Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Cognitive Dysfunction

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Web-based community-led, 12-week exercise program

Community based FTTs will use a web-based platform to deliver a 12-week exercise training program (120-minute group sessions of aerobic activity 3 times/week). Each session will include:

* Warm-up activities
* Aerobic activities and fitness training in a game-like fashion
* Organized sports/games
* Cool down activity
* Snack/reward time

Web-based Aerobic Exercise Program

Donald J Mabbott, Ph.D.

Cynthia de Medeiros, M.Sc.

Cynthia de Medeiros, M. Sc.

Donald J Mabbott

The study will assess the feasibility of a pilot clinical trial of community-led aerobic exercise training for paediatric brain tumour survivors (PBTS) and the feasibility of a web-based platform to deliver this exercise training. It is hypothesized that 12 weeks of community-led exercise training will be feasible for PBTS and the web-based platform will be feasible to deliver exercise training by community-based instructors.

PBTS will complete 12 consecutive weeks of exercise training. Exercise training will involve 90-minute group sessions of aerobic activity 3 times/week with a 30-minute snack/reward time. The investigators anticipate participants will complete the exercise training program in cohorts, each comprised of a minimum of 3 and maximum of 10 participants. With a minimum of 3 participants per cohort, in order for us to achieve the investigators' goal of recruiting 30 participants, the investigators anticipate running approximately 7 cohorts. Participants will be assigned to a cohort based on proximity to session location and availability to attend sessions.

Site Description:

This is a single-site trial, as participants will be recruited from SickKids. Community-led exercise training will be delivered at various locations across the Greater Toronto and Hamilton Area (GTHA). Exercise training sessions will be conducted in partnership with Wellspring, a network of community support services across the GTHA for individuals diagnosed and treated for cancer. The investigators have developed a web-based platform for Fitness Trainers/Therapists (FTTs) to i) educate them on working with PBTS, ii) build exercise session plans, and iii) provide feedback on sessions and overall web-based platform functionality and usability. The web-based platform will allow the administration of community-led exercise training in any location. To test the feasibility of the web-based platform, the investigators will be administering exercise training in approximately 5 locations associated with Wellspring centres (and/or surrounding gymnasiums or outdoor space) and Wellspring FTTs.

Study Intervention Description:

Exercise training will consist of group sessions of aerobic exercise. Each session will include five (5) components:

1. Warm-up activities
2. Aerobic training activities
3. Group sports/games
4. Cool-down activities
5. Snack/reward time The goal of the intervention is to increase and maintain participants' heart rate for at least 30 minutes per session at a minimum of 80% of participants' peak heart rate achieved during a baseline fitness assessment. Increased heart rate will mainly take place during the aerobic circuit training and group sport/game components of each session. Heart rate will be measured using heart rate monitors.

Description of study population:

* Sample size: n = 30
* Age: 6-17 years
* Sex: males and females
* General health: Patients who have completed treatment for hemispheric or posterior fossa tumours and do not have severe neurological/motor dysfunction that would preclude safe participation in an exercise program
* Geographic location: Canada

Fitness to Aid the Brain and Cognitive Skills

Development of a Web-based Exercise Training Program for Brain Repair and Cognitive Recovery for Paediatric Brain Tumour Survivors in the Community: a Feasibility Study

To compare community-led exercise training to historical data from a hospital-led exercise training for PBTS in terms of changes in hippocampal volume using MRI (magnetic resonance imaging).

Measures: Anatomical T1 weighted MRI will acquire estimates of hippocampal volume

To compare community-led exercise training to historical data from a hospital-led exercise training for PBTS in terms of changes in neural communication, as estimated by functional connectivity during magnetoencephalography (MEG) recording.

Measures: The weighted phase lag index (wPLI) will be used to measure functional connectivity during MEG recording as an estimate of neural communication

To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in information processing speed.

Measure: Scores on the Rapid Visual Information Processing subtest of the Cambridge Neuropsychological Test Automated Battery

To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in controlled attention.

Measure: Scores on the Match to Sample Visual Search Task subtest of the Cambridge Neuropsychological Test Automated Battery

To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in declarative memory.

Measures: Scores on the Delayed Matching to Sample Task subtest of the Cambridge Neuropsychological Test Automated Battery

To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in cardiovascular fitness, including heart rate, sub-maximal and and maximal work rates.

Measures: 6-Minute Walk Test and electrically braked cycle ergometer to measure heart rate, and sub-maximal and maximal pro-rated work rates

To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in physical functioning, including bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility).

Measure: Bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility) using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Minimum points scored: 0, maximum points scored: 80; higher scores account for greater motor proficiency (better outcomes)

To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in white matter microstructure using diffusion kurtosis imaging (DKI)

Measures: DKI will acquire kurtosis measures of water diffusion in the brain (mean, axial, radial kurtosis)

To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes hippocampal volume using Anatomical T1 MRI

Measures: Hippocampal volume estimated using Anatomical T1 MRI

To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in neural communication as estimated by functional connectivity during MEG recording.

Measures: The wPLI will be used to measure functional connectivity during MEG recording as an estimate of neural communication

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in information processing speed.

Measures: Scores on the Pattern Comparison Processing Speed Test subtest of the National Institutes of Health Toolbox and Reaction Time Task subtest RTI subtest of the Cambridge Neuropsychological Test Automated Battery

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in controlled attention

Measures: Scores on the Flanker Inhibitory Control \& Attention Task subtest of the National Institutes of Health Toolbox, and the Stop Signal Task, Rapid Visual Information Processing, and Match to Sample Visual Search subtests of the of the Cambridge Neuropsychological Test Automated Battery

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in declarative memory

Measures: Scores on the Children's Auditory Verbal and Learning Test-2 or Rey Auditory Verbal Learning Test (for participants who will be 18 years of age at the time of study completion) and Delayed Matching to Sample subtest of the Cambridge Neuropsychological Test Automated Battery

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in full scale intelligence.

Measures: Scores on the Vocabulary and Matrix Reasoning subtests of the Wechsler Abbreviated Scale of Intelligence-Second Edition

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in MEG behavioural measures.

Measures: Reaction time and accuracy scores on the Simple and Choice Visual-Motor Reaction Time Task, and Multi-Source Interference Task during MEG recording

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in health and QOL

Measure: Scores on the Patient-Reported Outcomes Measurement Information System - Global health 7+2, Pediatric Quality of Life Scale generic core scale, physical activity preference questionnaire and Habitual Physical Activity Scale. All health and QOL measures are parent-proxy reports.

To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in cardiovascular fitness, including heart rate, sub-maximal and and maximal work rates.

Measures: 6-Minute Walk Test and electrically braked cycle ergometer to measure heart rate, and sub-maximal and maximal pro-rated work rates

To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in physical functioning, including bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility), and ataxia.

Measure: Bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility) using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Minimum points scored: 0, maximum points scored: 80; higher scores account for greater motor proficiency (better outcomes), strength assessment conducted by a registered Physiotherapist and the Scale for the Assessment and Rating of Ataxia. Minimum points scored: 0, maximum points scored: 40; higher scores indicate increased severity of ataxia (worse outcome)

To investigate the impact of community-let exercise training in PBTS to improve physical functioning in the participant's daily life, as reported by their parent.

Measure: Parent report the ease of physical (and cognitive) activities in their child's daily life.

In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory patient recruitment. The goal is to recruit n=30 participants (≥25% probability)

Measure: The Bayesian probability statistic that 30 eligible patients will be recruited

In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory participant attendance. The goal is for a participant to attend ≥60% of exercise training sessions (≥80% probability of participants).

Measure: The Bayesian probability statistic that participants will rate the therapeutic alliance between participant/instructor as cooperative and collaborative.

In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory participant adherence to study procedures (neuroimaging, cognitive, health and quality of life (QOL), cardiovascular fitness and physical functioning assessments). The goal is for a recruited participant to complete all study procedures (≥80% probability).

Measure: The Bayesian probability statistic that a recruited participant will complete all study procedures

In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory instructor adherence to deliver the program. The goal is for instructors to adhere to the web-based platform to deliver exercise training (≥80% probability).

Measure: The Bayesian probability statistic that instructors will adhere to the web-based platform to deliver exercise training

In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory rating by the participant of the therapeutic alliance between participants and instructors. The goal is for participants to have a cooperative and collaborative relationship with the instructors, as rated by the Therapeutic Alliance Scales for Children-Revised questionnaire.

Measure: The Bayesian probability statistic that the therapeutic alliance between participant/instructor will be comparable across cohorts.

In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as acceptable (e.g. would recommend to others, would continue to use). The goal is for instructors to rate the the platform as acceptable, indicating ease of use and satisfaction (≥80% probability).

Measure: The Bayesian probability statistic that instructors will rate the platform as acceptable

In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as relevant (e.g. includes all necessary components to administer an exercise program, would choose to use such a tool to deliver an exercise program).The goal is for the instructors to rate the platform as relevant, indicating the presence of necessary information (≥80% probability).

Measure: The Bayesian probability statistic that instructors will rate the platform as relevant

In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as efficient (e.g. is useful). The goal is for the instructors to rate the platform as efficient, indicating its usefulness (≥80% probability).

Measure: The Bayesian probability statistic that instructors will rate the platform as efficient

The Hospital for Sick Children

Senior Scientist and Program Head

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants engage in low intensity endurance exercise.

Participants engage in moderate intensity endurance exercise.

This arm includes a low-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.

Exercise Program Low Intensity

This arm includes a moderate-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.

Exercise Program Moderate Intensity

Ana L Mulero-Portela, PhD

The purpose of this study is to evaluate the effect of two exercise programs: 1) one program will be at low intensity; 2) the other program will be at moderate intensity. One hundred forty two women who are breast cancer survivors will be recruited. Participants will be educated on a home exercise program to be performed at either low or moderate intensity, according to group assignment. Evaluations to participants will consist of function and quality of life.

Improvements in early diagnosis and treatment for breast cancer in women have resulted in increased survivorship. An unintended consequence of increased survival, however, is that more women are living with the negative sequelae associated with cancer treatment, including decreased physical function. Exercise has been beneficial in arresting these sequelae, but adherence to exercise guidelines continues to be a challenge. As most breast cancer survivors are middle-aged and older, an alternative to enhance exercise engagement and adherence might be providing a low intensity exercise program. The overall purpose of this study is to assess the impact of a low intensity versus moderate intensity endurance exercise program on physical functioning on breast cancer survivors. It is hypothesized that participants of the low intensity exercise program will demonstrate similar physical functioning as participants in the moderate intensity exercise program. The Theory of Planned Behavior will serve as framework for the intervention. A convenience sample of 142 women, residents of Puerto Rico, age 50 or older, with a diagnosis of breast cancer, stage 0 thru III, who have received surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly assigned to a low intensity or moderate intensity endurance intervention. Both interventions will be home-based, have a duration of 6 months, and be provided by physical therapists. An evaluator blinded to group assignment will assess participants at baseline and at completion of the intervention. Primary outcome measures will consist of physical functioning, and health-related quality of life.

Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors

Effect of Low-intensity Versus Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors: a Randomized Controlled Trial

Data will be presented at the conclusion of the study.

Will be used to assess physical function in cancer survivors. It has been validated to assess exercise tolerance (American Thoracic Society, 2002) and has been recommended as a test suitable for fitness, as it is highly correlated with oxygen uptake. An increase in walking distance indicates an improvement in performance. Data will be collected on distance walked (meters), number of rests, and duration of rest during the 6 minutes. Rating of perceived exertion will be monitored. Heart rate and oxygen saturation will be examined using a pulse oximeter.

Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0/1.1 General Health. The Spanish version (Salud general) will be used. It contains two subdomains: Global Physical Health and Global Mental Health. The final score can be converted to a score for the EUROQoL.

PROMIS Item Bank v. 1.2 Physical Function. The Spanish version (Capacidad de Funcionamiento Físico - Cuestionario Abreviado 20) will be used. It consists of 20 items, measuring upper extremity function, as well as gross motor function such as walking and stairs use.

Inventario -II de depresión de Beck (BDI-II). The Spanish version has proper psychometric properties for assessment of depression (internal consistency, obtaining a Cronbach alfa of 0.89 and has reported known-group validity; Vega-Dienstmaier, 2014).

Body Appreciation Scale-2 (BAS-2; Tylka \& Wood-Barcalow, 2014), Spanish version will be used to measure body appreciation, an aspect that encompasses positive self-evaluation of body image. It has 13 items with responses ranging from 1 (never) to 5 (always). The Spanish BAS showed adequate internal consistency (Cronbach's α = .91) and construct validity (correlations with BMI, influence of the body shape model, perceived stress, coping strategies, self-esteem and variables from the Eating Disorders Inventory-2). Test-retest reliability ranged from .88 to .90.

Accelerometers will be used to evaluate the amount of time spent in low to moderate and moderate to vigorous physical activity. Accelerometry has been found to be a valid measure of physical activity, as compared to oxygen uptake and calorimetry (Hendelman et al., 2000; Kuffel, et al., 2011) and has been used nationally by the National Health and Nutritional Examination Survey (NHANES) study to document, more precisely than self-reported measures, the intensity and time of physical activity (Hawkins et al., 2009). The procedures established by NHANES (CDC, 2005) will be followed.

International Physical Activity Questionnaire (IPAQ, 2002, self-administered, long Spanish version). The IPAQ assesses multiple domains of activity such as leisure, occupation, household, and transport, among others (Craig et al., 2003). This questionnaire has proved to be reliable (Roman-Viñas et al., 2010), and has been validated with accelerometer, pedometer, physical activity log, and maximal oxygen uptake (van Poppel et al., 2010).

Exercise logs. Participants will be asked to record week number and type and duration of exercise. Logs will be collected at the 6-month evaluation session.

University of Puerto Rico

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

progressive resistance training (2x/week), starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery with only low-to-moderate-intensity training during the first 4 weeks.

Six months supervised resistance training

Home-based exercise training (2x/week) with initial counseling and weekly telephone contact starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery.

Six months home-based exercise training

Karen G Steindorf, Prof. Dr.

The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.

The randomized-controlled balanced-parallel-group trial included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg. The study compared two specific exercise interventions and one standard care control arm. The intervention programs were (1) a 6-month supervised moderate-to-high-intensity, progressive resistance training, and (2) a 6-month home-based exercise training. Thus, the two interventions differed primarily by the intensity and mode-of-administration of the intervention. Both interventions started at the earliest 8 weeks after surgery to allow for wound healing until Maximum 12 months after the surgery. The supervised progressive training started with only moderate-intensity training during the first 4 weeks. Only patients without comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability) were eligible.

The primary objective is to compare the effects of the different interventions on physical functioning, measured as change from baseline to 6 months. Additional endpoints are overall quality of life, fatigue, endurance, and strength performance, adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes has been assessed every 3 months for a minimum follow-up period of 12 months.

Exercise Intervention Study for Pancreatic Cancer Patients

SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial

University of Heidelberg Medical Center

Deutsche Krebshilfe e.V., Bonn (Germany)

German Cancer Research Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Kidney Diseases

Heart Failure

Lung Diseases

Liver Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Jan Christensen

Purpose: To determine unmet functional needs in patients referred to the Palliative Care Unit at Rigshospitalet, Copenhagen University Hospital will be asked to fill out self reported questionnaires regarding problem intensity, problem burden and felt needs, physical functioning, emotional functioning, fatigue, sleep, distress. Furthermore patients physical function will be evaluated.

Physical functioning is found to be an important predictor for survival and physical ability 'to do what one wants' affects quality of life in cancer patients in palliative care and their spouses. Despite this, physical functioning is reported as a neglected dimension in palliative care quality of life outcome measures, and advanced cancer patients report that they do not receive the help they need. The vast majority of patients with advanced cancer described unmet palliative care needs, and with the most frequently reported problems being; fatigue (73%), limitations doing physical activities (65%), limitations in work and daily activities (58%), worry (58%), difficulties with sexuality (54%), pain (52%) and problems with concentration (43%). Furthermore, limitations in physical functioning and physical activity is a leading cause of distress and psychological problems a rehabilitative approach in palliative care integrated in the interdisciplinary interventions to the patients must be maintained throughout the entire illness trajectory from diagnosis through treatment, rehabilitation and palliative care to address such problems.

However, prevalence of patient unmet needs and reported physical functioning and performance is reported to differentiate largely between palliative units.

In order to address the functional needs of patients receiving specialist palliative care studies of their specific needs are required. Therefore, the aim of this study is to investigate the patient reported unmet needs for function and supportive occupational- and physiotherapy rehabilitation interventions in the palliative unit at Copenhagen University Hospital, Rigshospitalet. Furthermore, we aim to investigate if observations, additional disease-specific patient reported outcomes and assessment of physical function and performance can support the unmet needs.

Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions

Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting

The Three-Levels-of-Needs Questionnaire (3LNQ)

Maximum strength test by handgrip dynamometer

Hospital Anxiety and Depression Scale (HADS)

Functional Assessment of Cancer Therapy - Fatigue (FACT-F) 13 item fatigue subscale

The Canadian Occupational Performance Measure (COPM)

International Physical Activity Questionnaire (IPAQ) short form

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fitness to Aid the Brain and Cognitive Skills	NCT05367076	Pediatric Brain... Cognitive Impai...	Web-based Aerob...	6 Years - 18 Years	The Hospital for Sick Children
Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors	NCT02982564	Breast Neoplasm...	Exercise Progra... Exercise Progra...	50 Years -	University of Puerto Rico
Exercise Intervention Study for Pancreatic Cancer Patients	NCT01977066	Pancreatic Canc...	Six months supe... Six months home...	18 Years -	German Cancer Research Center
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions	NCT04066153	Cancer Kidney Diseases Heart Failure Neurologic Diso... Liver Diseases Pulmonary Disea... Side Effect Quality of Life Physical Disord...		18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for physical functioning