Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Fibrosis

Liver Diseases

Gastrointestinal Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Hematinics

All Drugs and Chemicals

Liver Extracts

Conventional medical care and 8 weeks of a Prehabilitation supervised program

Conventional medical care, 8 weeks of a Prehabilitation supervised program and a posttransplant training program.

Supervised training program of 8-weeks and a frequency of 2 days/week. It includes interval aerobic exercise (5 cycles of 2 minutes at 70 percentage of Watts or heart rate of cardiopulmonary exercise testing (CEPT) and 3 minutes of active rest at 40 percentage; peripheral muscle training and balance exercises in a circuit of 10 phases, 10 to 15 repetitions, from 1 to 3 sets (the participants will work at moderate intensity, no more than 5-6/10 on the modified Borg scale); Inspiratory Muscle Training (IMT) through a threshold loading device \[2 sessions / day, 3 sets of 15 repetitions, at 60-70 percentage of the maximum inspiratory pressure (cmH2O)\]; ventilatory reeducation by an incentive inspirator based on the vital capacity evaluated in the initial spirometry. Both the aerobic modality and the resistance training, will increase the intensity of work (HR, Watts, Kg or cmH2O) between 2-5 percentage every 2 weeks complying with the principle of training overload.

Prehabilitation

Prehabilitation will be followed by a posttransplant training program. In this, the patient will perform supervised exercise (IIa interval aerobic exercise and resistance training) 2 days / week, and a physical exercise program at home until completing a total of 5 sessions / week in the aerobic modality. In the unsupervised phase (IIb), the patient will continue with the learned physical exercise program, but without supervision, 5 sessions / week (including a minimum of 2 non-consecutive sessions to perform resistance training).

Prehabilitation and posttransplant training program

Maria A Cebrià i Iranzo, PT, PhD

David Calatayud Mizrahi, MD, PhD

Natalia Cezón Serrano, PT

Luis Compte Torrero, MD, PhD

Laura Arjona Tinaut, PT

Rafael López Andújar, MD, PhD

Martín Prieto Castillo, MD, PhD

PreLiveR-T consists of a prospective randomized clinical trial conducted in an adult population that is a candidate for liver transplantation (LT) at the Hospital La Fe Valencia (Spain). The study is structured in three phases: I) Prehabilitation (2 months before LT); II) Training, divided in two successive periods: Supervised training (months 3-6 after LT) and Unsupervised training (6-12 months after LT); III) Long-term follow-up (2 years after LT).

Primary outcomes are related to post-surgery evolution (morbidity and mortality, hospitalization length, etc.). As a secondary outcomes are collected those related to: functional capacity, muscle strength and quality of life.

The main objective is to study the post-surgical impact (post-S) of a Prehabilitation program on candidates for liver transplantation (LT), as well as to study the effects of posttransplant training on the clinical and functional evolution of the recipients. Also this project pretends to assess the influence of functional capacity (FC) improvement on the short and long term post-S evolution of the LT candidates. This is a prospective randomized clinical trial in which three phases follow: Prehabilitation, training and follow-up. The sample will be constituted by 60 candidates for LT, randomized in a control group (CG, n=20), a Prehabilitation group (PG, n=20) and a Prehabilitation-posttransplant training group (PTG, n=20). To conventional care, a Prehabilitation program will be added to the PG and PTG. After the LT, just PTG will follow a posttransplant training program. The long-term follow-up will be extended to 2 years post-LT. The variables under study will be: complications and post-S evolution; FC; quality of life; etc. The individualization of Prehabilitation and posttransplant training program, and also medical control, will ensure safety and offer the potential benefits that these types of programs can provide.

Prehabilitation and Posttransplant Training Program in Liver Transplantation

Effects of a Prehabilitation Program in Liver Transplant Candidates Followed by a Posttransplant Training Program

Registry of post-surgical complications according to the Clavien-Dindo classification. Reference: Ann Surg 2004; 240(2):205-13.

Registry of number of days of hospitalization in intensive care unit and ward.

Days of acquisition, sitting, walking and stairs

Cardiopulmonary exercise test following an incremental protocol on ramp with a bicycle ergometer.

6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis. American Thoracic Society (ATS) Statement Guidelines for the Six-Minute Walk Test. Am J Resp Crit Care Med 2002;166(1):111-117

Isometric peripheral muscle strength will be measured using a digital hand dynamometer and the unit of measure is kilograms. References:

Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall CC, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age and Ageing 2011;40(4):423-9.

Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996; 76(3):248-59

Maximum respiratory pressures will be measured using a Respiratory Pressure Meter MicroRPM® and the unit of measure is cmH2O. MIP and MEP are probably the most frequently reported non-invasive estimates of respiratory muscle strength. Ever since Black and Hyatt (1969) reported this technique it has been widely used in patients, healthy control subjects across all ages, and athletes. Pressure is recorded at the mouth during a quasi-static short (few seconds) maximal breathing. Reference: Am J Respir Crit Care Med. 2002;166:531-535

The SPPB is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines three areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. Static balance is measured in units of time (seconds) and patients are timed holding 3 different stances. Gait speed is measured in time (seconds) to walk 4 meters. Chair sits are measured as the time (seconds) it takes to get up and out of a chair 5 times without using one's arms to assist the exercise. Collectively, the three tests are used to generate a total score (0-12) that reflects a patient's frailty (score of 0) or lack of frailty (score of 12). Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994;49:M85-M94.

Bioelectrical impedance analysis will be completed using the Bodystat 1500 MDD, which is a multi-frequency body composition analyzer. Body fat percentage (%) will be compared to lean body mass percentage and total body water percentage to assess sarcopenia and nutritional status.

Short-Form Liver Disease Quality of Life (SF-LDQOL) is formed by 9 dimensions: symptoms of the disease, effects of the disease on the activities of daily life, memory/concentration, anxiety, sleep, loneliness, hopelessness, stigma for the disease and sexual functioning. The minimum and maximum values of the scale are 0-100, so that the higher the score, the better health related quality of life (HRQL).

University of Valencia

Maria dels Angels Cebria i Iranzo, PT, PhD

Director research

Skin and Connective Tissue Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Breast Neoplasms

Neurotoxicity Syndromes

Syndrome

Breast Diseases

Skin Diseases

Poisoning

Chemically-Induced Disorders

A multimodal program based on adapted therapeutic exercise and vagal activation techniques performed before the begining of medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception).

ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention.

A multimodal program based on adapted therapeutic exercise and vagal activation techniques performed throughout medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception).

ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention.

Patients will perform therapeutic exercise and vagal activation techniques before medical treatment and will follow the usual care after medical treatment.

ATENTO-B

Patients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment.

ATENTO-T

Irene Cantarero Villanueva, PhD

Irene Cantarero-Villanueva, PhD

The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.

One of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system. Neurotoxicity is present in up to 75% of this population, which implies a large impact in quality of life. There is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae, whose benefits could improve thanks to the combination with vagal activation techniques.

This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention (ATENTO) based on moderate-high intensity and individualized therapeutic exercise (aerobic and strength exercises) and vagal activation techniques (myofascial stretching and breathing exercises), on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments (ATENTO-B) versus throughout them (ATENTO-T). A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85% will be allocated into two groups.

This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments.

Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)

Neurotoxicity Prevention With a Multimodal Program (ATENTO) Prior to Cancer Treatment Versus Throughout Cancer Treatment in Women Newly Diagnosed for Breast Cancer: a Randomized Clinical Trial.

The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0, that is one of the most widely used instruments to measure quality of life in cancer patients.

The Trail Making Test will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.

Wechsler Adult Intelligence Scale (WAIS-IV) will be used to assess working memory and processing speed

The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.

The EORTC QLQ-Chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) will be used to assess neuropathic symptoms.

The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy.

The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression.

Pressure pain thresholds (PPT) will be used to explore bilaterally the quadriceps, deltoid, trapezius and cervical muscles using an algometer.

The Pittsburgh Sleep Quality Index (PSQI) will evaluate the quality of sleep through seven dimensions (quality, latency, duration, efficiency, alterations, use of medication and daily dysfunction).

Cardiopulmonary exercise test will be performed with a Medisoft, 870 A treadmill and Jaeger MasterScreen® CPX gas analyser to assess VO2 peak following the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI).

Flamingo test will be used to assess static body balance

Asociación Española contra el Cáncer

Universidad de Granada

Irene Cantarero Villanueva

Wounds and Injuries

Fatigue

Head and Neck Neoplasms

Accessory Nerve Injuries

Accessory Nerve Diseases

Cranial Nerve Diseases

Cranial Nerve Injuries

Craniocerebral Trauma

Trauma, Nervous System

Therapeutic Exercise Program (standard care) will include:

1. Neck range of motion and strengthening, and posture retraining.
2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.

The Therapeutic Exercise Program (standard care) will include:

1. Neck range of motion and strengthening, and posture retraining.
2. Shoulder specific progressive resistance exercise program that focuses on spinal accessory nerve dysfunction and rehabilitation of trapezius muscle function.

The Resistance Exercise component will target 6-8 muscle groups of the lower extremities and core including gluteal, quadriceps, hamstrings, abdominals, and gastrocnemius muscles. A progressive introduction of exercises will occur over the first 3 weeks.

1. a personalized program of lower extremity resistance exercises
2. core strengthening exercises

A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.

Therapeutic Exercise

A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise

Therapeutic + Lower Body Exercise

Margaret L. McNeely, PhD

The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

Participants will be stratified by early (within 18 months of surgery) and late (\> 18 months of surgery) and randomized on a one-on-one basis to (1) a supervised therapeutic exercise program for the neck and shoulder (serving as standard care) or (2) a combined therapeutic and lower body resistance exercise program. The randomization sequence will be generated by staff in the Rehabilitation Research Centre at Corbett Hall and placed in sealed opaque envelopes.

The exercise program will be offered in a group setting. Participants will exercise 2 times per week for a 10-week session and will have the option to continue for an additional 10-week maintenance session. The primary outcome for the study will be quality of life as measured by the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale at 12-weeks.

At each measurement point following the baseline assessment, including the 12-week and 24-week and one year follow-ups, an Independent Assessor will perform the objective fitness measurements. The Independent Assessor will also administer the Neck Dissection Impairment Questionnaire and the FACT-Fatigue quality of life questionnaires. The Physical Activity Adherence Diary will be collected by a Research Coordinator at each follow-up visit.

Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

Evaluating Outcomes From a Combined Supervised Therapeutic and Physical Exercise Program for Post-surgical Head and Neck Cancer Survivors: A Randomized Controlled Trial

Godin Leisure Time Questionnaire: minutes of mild, moderate and strenuous exercise.

costs to programming, institution and participants

Adherence to exercise programming: attendance at supervised exercise sessions and self-directed sessions over the 1 year period.

Active and passive glenohumeral joint range of motion using standard 12 inch goniometer.

Derived from height and weight of the participant.

The maximal amount weight that can be pulled (seated row) and pushed (vertical bench) with proper form.

Measures of neck flexion, side flexion, rotations and extension using myrin goniometer.

Maximal repetitions to fatigue based on 50% of 1 repetition maximum strength for seated row.

Maximal grip strength: composite score of both hands. Best of three attempts for each side.

The maximal amount of weight that can be moved with proper

The maximal amount of weight that can be pushed with proper form.

number of repetitions performed in 30 seconds

The composite score of physical, functional and fatigue subscales of the questionnaire.

Cross Cancer Institute

University of Alberta

Associate Professor

Behaviors and Mental Disorders

Pain

Chronic Pain

Neurologic Manifestations

Quality of Life

Chronic Graft Versus Host Disease

Participants will receive a 3-month online physiotherapy program comprised of 'pain neuroscience education' (month 1) and 'gradual exposure to movement' (month 2 and 3). They will receive an informative booklet online.

Participants will receive the 'usual care'. They will receive an informative booklet online and the possibility of receiving the therapeutic program, once the study is completed.

Online group therapeutic program (small groups), applied for 3 months.

Online physiotherapy protocol based on pain neuroscience education and gradual exposure to movement.

Patricia Martínez Miranda

Introduction: Pain stands out among the sequelae that affect the quality of life of breast cancer survivors. Pain neuroscience education and graded exposure to movement are therapeutic approaches that have been shown to be effective in the management of chronic pain in other populations. However, there are no previous studies that combine them in this population. Objective: To evaluate the effectiveness of an online physiotherapy focused-person program which combines pain neuroscience education and graded exposure to movement, to improve the quality of life of breast cancer survivors. Methodology: The design of the study is a randomised controlled clinical trial and the sample will be 40 breast cancer survivors with pain in the last 6 months. A random method will be used to assign participants into two groups (experimental and control). The evaluator and statistician will be blinded to participant allocation while the experimental group will receive the therapeutic program which combines pain neuroscience education and graded exposure to movement-based intervention throughout therapeutic yoga; the control will be a passive group. There will be four points of assessment: the main outcome assessed will be quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the secondary outcomes are variables related to pain experience (catastrophising, self-efficacy, kinesiophobia and fear-avoidance behaviours). All will be assessed using validated methods. SPSS program will be used for the data analysis. A mixed-model analyses of variance ANOVA (2x4) will be used to study the effects of the treatment on the dependent variables. An intention-to-treat analysis will be performed. All statistical tests will be performed considering a confidence interval of 95%. Trial record: NCT04965909.

Study Design A randomised controlled clinical trial will be carried out according to the Consolidated Standards of Reporting Trials (CONSORT) Statement for its development. In addition, the Template for Intervention, Description and Replication Checklist (TIDieR) will be used as a guide to provide transparency and make the intervention replicable. Also, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to develop this protocol. The protocol of this study has been registered on clinicaltrials.org with the registry number: NCT04965909.

Sampling method and sample's size calculation For sampling, non-probabilistic convenience and snowball methods will be used. Sample size was calculated using the G\*Power software, version 3.1.9.7 (Heinrich-Heine University, Düsseldorf, Germany), and considering the previous data reported by Park et al., (2012) for the variable global Quality of life (Functional Assessment of Cancer Therapy - Breast, FACT-B). We considered 2 groups and 4 measurements, a type I risk or α 0.05, type II risk or β 0.20 (study power of 80%), and a partial Eta2 effect size of 0.049. This generated a sample of 40 individuals, including an estimated 15% dropout rate. Figure 1 shows the study flow diagram.

Subjects' recruitment The sample for this study will be recruited through the dissemination of the project using social networks and with the collaboration of three Spanish breast carcer survivor support associations (Amama Sevilla, AGAMAMA and ASAMMA). Participation in the study will be voluntary. All participants will be facilitated by written informed consent that must be signed to be part of the clinical trial.

Group assignment and masking This study will have two groups (experimental and control). For assignment, a random method will be carried out using an online tool called 'random allocation software'. A stratified allocation was applied according to the women's age (≤45 years old or \>45 years old). On each of the strata, a randomisation will be carried out by blocks of constant size. The assignment sequence will be hidden from the evaluator and the study subjects through an automated assignment system. The preparation of the sequence, the inclusion of the individuals in each group and the assignment of the treatments will be carried out by different members of the research team. On the other hand, the evaluator and statistician will be blinded. Nonetheless, the therapist and subject will not be able to be blinded because of the type of intervention.

Assessment points, method of data collection and outcomes The outcomes will be assessed at four points during the entire study period: before the intervention (T0), after the experimental group completes the first part of the intervention based on PNE (T1), after complete intervention (T2) and at the 3-month follow-up (T3) (Figure 2).

All data will be collected in a format model. All data were encrypted and only members of the research team will have access to the data of the participants. The outcomes will be assessed using validated scales or questionnaires that women will complete by themselves. In addition, extra information related to their pain context will be collected by two evaluators in an online meeting. The evaluators will have previous experience in the issue and will be trained before the interviews.

The main outcome of this trial is quality of life measured by The Functional Assessment of Cancer Therapy - Breast (FACT-B+4). In addition, five secondary outcomes related to health will be measured: intensity of pain using the Brief Pain Inventory - Short Form (BPI-SF), catastrophising level using the Pain Catastrophising Scale, self-efficacy level using the Pain Self-efficacy questionnaire (PSEQ), Kinesiophobia using the Tampa Scale for Kinesiophobia (TSK-11) and fear-avoidance behaviours using the Fear Avoidance Components Scale Questionnaire - Spanish Version (FACS-SP).

Method for results and data analysis For the data analysis, a data matrix will be prepared according to the coding methods that have been described in the outcomes section. A descriptive and inferential statistical analysis will be carried out, assuming that the groups are independent. The SPSS program, version 26.0 for Windows will be used for data analysis.

First, the Shapiro-Wilk test will be used to determine whether there is a normal distribution. Then, a descriptive analysis of the data will be conducted. The absolute count and percentages of each category will be calculated in the nominal qualitative variables. For the quantitative variables adjusted to the normality, the mean and standard deviation will be provided, while the median and the first and third quartiles will be provided in those that are not adjusted to normality. Next, the homogeneity in the baseline between the experimental and control groups will be studied with respect to the sociodemographic and clinical variables and pre-test of all dependent variables. In the dichotomous nominal qualitative variables, Pearson's bilateral asymptotic Chi2 test will be used, or, failing that, Fisher's exact test. In the polytomous nominal qualitative variables, Pearson's bilateral asymptotic Chi2 test or Pearson's exact test will be used. On the other hand, in the quantitative variables adjusted to normality that are homoscedastic, we will use the student's t test for independent samples and the Welch t test in those that are heteroscedastic. In quantitative variables that do not adjust to normality, the Mann-Whitney U test will be used. On the other hand, in those variables in which the 4 measurements are adjusted to normality in both intervention groups, a mixed-model analyses of variance factorial ANOVA (2x4) will be used to study the effects of the treatment on the dependent variables evaluated in the present investigation, considering the group as a between-subject factor and time (the different measurements performed) as a within-subject factor. The hypothesis of interest will be the interaction group by time with an a priori alpha level of 0.05. In addition, the effect size of the observed differences will be estimated by calculating the partial Eta squared coefficient. In those variables in which none of the measurements in either of the two intervention groups adjust to normality, the following analyses will be implemented: the measurements made of the intragroup dependent variables will be compared (considering each of the intervention groups in isolation). In those variables in which all of the measurements are normal in one of the two intervention groups, we will use the ANOVA test of repeated measures. If any of the measurements do not adjust to normality, we will use the Friedman ANOVA test. Next, to compare the inter-group dependent variables, the difference between the value of each pair of measurements will be calculated for each dependent variable, calling such values "differences". In addition, the percentages of change in the scores between each pair of measurements were established. Finally, the values obtained in the "differences in scores" and in the "percentage changes in scores" in the two groups will be compared. For this we use Student's t test for independent samples, in the differences and percentages of change that are normal and homoscedastic, while in the normal and heteroscedastic we will use the Welch t test. The effect size was estimated by calculating Cohen's d coefficient. In the event that such differences are not normal, we will used the Mann-Whitney U test and the effect size will be found by calculating Rosenthal's r with the formula: r=Z/√N. An "intention to treat" analysis will be performed in the study of the effects of the applied intervention. All statistical tests will be performed considering a confidence interval (hereinafter CI) of 95% (p-value \<0.05).

Planned timing The project would be carried out from 2020 to 2024.

Ethical considerations For the preparation of this study, all relevant ethical considerations have been made. In addition, this program has the approval of the Research Ethics Committee (CEI) of the Virgen Macarena - Virgen del Rocío University Hospitals.

In accordance with Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights and prior verbal and written information, this study will have the express written consent of each participant. This will be delivered together with the informed consent revocation sheet. All personal data will be treated properly, not being disclosed under any circumstances and not being misused.

A Randomized Controlled Clinical Trial of two groups (experimental and control) will be carried out.

double-blind (researcher and statistician)

Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors

Online Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors: Protocol of a Randomised Controlled Trial.

The personal data of the participants will be treated in accordance with the Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights

Quality of life measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4). The FACT-B+4 is a 41-item instrument designed to measure six domains of QOL in breast cancer patients: Physical, social, emotional and functional well-being, and breast-cancer (BCS) and lymphedema (ARM) subscales. The score obtained ranges from 0-148 points. The ARM subscale was not included in the total score. A higher score translates into a better quality of life.

Pain intensity measured by the Brief Pain Inventory - Short Form (BPI - SF). The PBI -SF is a 9-item instrument designed to measure pain intensity and pain interference with the diary daily activities. The questionnaire has two subareas, one related to pain intensity, whose score ranges from 0-50, with a higher score being an indication of greater intensity; and another related to the interference of pain in activities of daily living, whose score ranges from 0-70, with a higher score being indicative of a greater impact on daily life.

Catastrophim level measured by the Pain Catastrophizing Scale. This scale allows us to assess the degree of catastrophizing of pain in adolescents and adults who face this condition as a result of various pathologies or diseases. The scale consists of 3 subscales (rumination, magnification and helplessness), whose items will be valued from 0 (nothing) to 4 (all the time) to obtain a total score that ranges between 0-52. A higher score translates into a higher level of catastrophizing.

Self-efficacy level measured by the pain self-efficacy questionnaire (PSEQ). The PSEQ is a 22-item instrument designed to measure self-efficacy level. Each item is scored from 0 - 10. 0 is equal to 'I think I am totally incapable' and 10 is equal to 'I think I am totally capable'. The total score ranges from 0-220. A higher score on the questionnaire corresponds to a higher level of self-efficacy.

Kinesiophobia measured by the Tampa Scale for Kinesiophobia (TSK-11). This scale is one of the most used to evaluate kinesiophobia in patients with pain. It is composed of two factors (avoidance of activity and harm) with a total of 11 items that are valued from 1 (totally disagree) to 4 (totally agree). The total score obtained ranges from 11 - 44. More punctuation shows higher kinesiophobia level.

Fear avoidance beliefs measured by the Fear Avoidance Components Scale Questionnaire - Spanish Version (FACS - SP) . The FACS- SP is a questionnaire that allows us to evaluate patient's fear of pain and consequent avoidance of physical activity due to fear. The questionnaire consists of 20 items in which a patient rates his agreement with each statement on a 6-point Likert scale. Where 0 = completely disagree, 6 = completely agree. There is a maximum score of 100. A higher score indicates more strongly held fear-avoidance beliefs. Five severity levels are available for clinical interpretation: subclinical (0-20), mild (21-40), moderate (41-60), severe (61-80), and extreme (81-100).

University of Seville

Doctoranda Programa del Doctorado Interuniversitario en CCSS

Peripheral Nervous System Diseases

Small Fiber Neuropathy

Neuromuscular Diseases

An adapted therapeutic exercise program using blood flow restriction cuff perfomed during chemotherapy treatment. 24-36 sessions of 1 hour multimodal components: aerobic, strength and fascial release exercises. Frequency will be adapted to the recovery status of each patient.

Patients undergoing usual medical treatment

Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment

PRESIONA

Noelia Galiano-Castillo, Phd

Irene Cantarero-Villanueva, Phd

María de la Cabeza López-Garzón, MSc

The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.

CIPN is a side effect of cancer therapies that nowadays has no solution, so our intention is to carry out a preventive therapy against the onset of CIPN. The nature of the studies that try to prevent is very diverse, but one of the wide tools is therapeutic exercise. In this case we intend to combine therapeutic exercise with BFR to obtain a pre-conditioning effect that protects intraepidermal fibers from exposure to the chemotherapy.

Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program

Symptoms across to sensory, motor and automic domains will be measured using the questionnarie the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased symptom burden.

assessed by European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased quality of life.

assessed by clinical version of The Total Neuropathy Score. Each item is scored from 0 to 4, with the total score ranging from 0 to 24 points; a higher score indicates greater neuropathy severity.

assessed by Pittsburgh Sleep Quality Index that is a self-rated questionnaire which assesses sleep quality and disturbances. The global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties.

assessed by Scale for Mood Assessment. The scale tries to assess four moods; anxiety, angerhostility, sadness-depression, and happiness. Itd subscale is scory from 0 to 10, a higher score in the EVEA subscales would indicate that the respondent has a higher level of sad-depressed, anxious, angryhostile, and happy mood, respectively.

assessed by visual analogue scale. From 0 to 10, a higher score is a worse subjective pain in hands and feet.

assessed by Semmes-Weinstein filaments (SWMs)

assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)

assessed by the 6 minutes walking test. A greater distance (meters) covered over 6 min indicates greater mobility and general functioning.

Principal Investigator

Heart and Blood Diseases

Cardiotoxicity

An adapted therapeutic exercise program performed before medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).

An adapted therapeutic exercise program performed during medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).

Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.

ATOPE-B

Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.

ATOPE-I

Manuel Arroyo-Morales, PhD

The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.

The positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. To date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits.

In this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival.

This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.

Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program

Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer

To assess cardiac toxicity by echocardiography

Number of cardiovascular events registered in a diary

To assess cardiac autonomic system balance by a Holter

With the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures. Values are assigned between 1 and 4 (1: not at all, 2: a little, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 evaluate with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of cancer impact on the patient of each of the scales. The high values in the scales of global health and function state indicate a better CV, while in the scale of symptoms it would indicate a decrease in CV since it indicates the presence of symptoms associated with cancer.

European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. After the scoring procedures for the QLQ-C30, all scale and single-item scores are linearly transformed to a 0 to 100 scale. For the functional scales and single items (ie, body image, sexuality, and future perspective), higher scores represent a better level of functioning. For the symptom scales and single item, a higher score represents a higher level of symptoms.

type of chemotherapy agent used and number of sessions.

delay of doses or reduction, total doses received from the total expected.

Patient stopped receiving chemotherapy before last \>=1 sessions.

Adverse effects of chemotherapy treatment and if it was interrupted (\>=3 missing consecutive bouts of exercise)

\>=1 bout that required a dose modification during the program and number of bouts modified in total.

days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.

Frequency of serious and non-serious events occurring during program.

assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan

assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)

assessed by the Modified sit-and-reach test

Thiobarbituric acid reactive substances (TBARS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prehabilitation and Posttransplant Training Program in Liver Transplantation	NCT04246970	Liver Transplan... Cirrhosis, Live... Hepatic Carcino...	Prehabilitation Prehabilitation...	18 Years -	Hospital Universitario La Fe
Prehabilitation and Posttransplant Training Program in Liver Transplantation	NCT04246970	Liver Transplan... Cirrhosis, Live... Hepatic Carcino...	Prehabilitation Prehabilitation...	18 Years -	Hospital Universitario La Fe
Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)	NCT04583124	Breast Neoplasm	ATENTO-B ATENTO-T	18 Years - 70 Years	Universidad de Granada
Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors	NCT02647021	Head and Neck N... Accessory Nerve... Fatigue	Therapeutic Exe... Therapeutic + L...	18 Years -	University of Alberta
Prehabilitation and Posttransplant Training Program in Liver Transplantation	NCT04246970	Liver Transplan... Cirrhosis, Live... Hepatic Carcino...	Prehabilitation Prehabilitation...	18 Years -	Hospital Universitario La Fe
Pain Neuroscience Education and Graded Exposure to Movement in Breast Cancer Survivors	NCT04965909	Breast Neoplasm... Pain, Chronic Quality of Life	Online physioth...	18 Years - 65 Years	University of Seville
Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program	NCT04652609	Breast Neoplasm	PRESIONA	18 Years - 70 Years	Universidad de Granada
Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program	NCT03787966	Breast Neoplasm...	ATOPE-B ATOPE-I	18 Years - 70 Years	Universidad de Granada

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