Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Body Weight

Breast Diseases

Skin Diseases

Quality of Life

Aerobic Exercise Training

Resistance Exercise Training

Kerry S Courneya, PhD

The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.

The study was a prospective, three-armed, randomized controlled trial. Participants were stratified by site (Edmonton, Ottawa, and Vancouver) and planned chemotherapy protocol (taxane-based versus nontaxane-based) and randomly assigned to AET, RET, or usual care (UC) in a 1:1:1 ratio using a random-numbers table. Participants assigned to the AET group were asked to perform aerobic exercise three times per week on a recumbent or upright cycle ergometer, treadmill, or elliptical. Exercise duration began at 15 minutes for weeks 0 through 2, and then systematically increased by 5 minutes every three weeks thereafter to 45 minutes for weeks 18 and beyond. Exercise intensity began at 60% of VO2max for weeks 0 through 2 and then systematically increased by 10% every 6 weeks thereafter to 80% of VO2max for weeks 12 and beyond. Warm-up and cool-down periods consisted of 5 minutes of aerobic activity at the power output of the ventilatory equivalent for oxygen (approximately 50% of peak oxygen consumption). Participants assigned to the RET group were asked to perform resistance exercise three times per week, which consisted of two sets of 10 repetitions of 9 different exercises performed at 60-70% of 1-repetition maximum. The specific exercises were: leg extension, leg curl, calf raises, chest press, latissimus pulldown, overhead press, triceps extension, biceps curls, and modified curl-ups. Resistance was increased by approximately 10% or the next weight level when the participant was able to complete 12 repetitions per set without difficulty.

Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy

Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial

Canadian Breast Cancer Research Alliance

University of Alberta, Physical Education

Inflammation

Menopause

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Postmenopausal breast cancer survivors undergoing tamoxifen treatment, who will do the evaluations before the beginning and after 12 weeks of exercise training and subsequently 12 weeks of detraining.

The exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals.

Resistance exercise training

The exercise detraining will last 12 weeks without exercise.

Exercise detraining

The present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

The present study aimed to verify the effects of 12 weeks of resistance exercise training and successive 12 weeks of detraining on body composition (Body Mass, Body Mass Index, Fat Mass, and Fat-Free Mass), lipid profile (Triglycerides, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol), muscle strength (1RM test), oxidative stress (Thiobarbituric acid reactive substances,Non-Protein Thiols, Catalase activity, and Superoxide Dismutase), and inflammatory markers (Interferon γ, Tumor Necrosis Factor α, interleukin 6 , Adiponectin, and Interleukin 4) of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors

Effects of Training and Detraining on Body Composition and Inflammatory, Oxidative and Lipid Profiles of Postmenopausal Breast Cancer Survivors Undergoing Tamoxifen Treatment

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. Serum levels of IL-4, IL-6, IFN-γ, TNF-α and Adiponectin will be determined by enzyme-linked immunosorbent assays (ELISA) using commercial kits (BD Biosciences, San Jose, CA, USA), according to the manufacturer's instructions, in an Immulite 2000 analyzer (BD Biosciences, San Jose, CA, USA). Expressed in pg/mL.

Blood samples will be collected after 8-10 hours overnight fasting in evacuated tubes containing separator gel. After 10 min centrifugation at 3000 rpm, the serum will be stored at -80 °C for further analysis. Lipid peroxidation was estimated by determining the serum concentration of thiobarbituric acid reactive substances (TBARS). The TBARS concentration will be obtained by spectrophotometric reading at 535 nm and interpolation in a malondialdehyde calibration curve. Oxidative damage to serum proteins will be estimated by determining the concentration of carbonylated proteins by reading the absorbance at 370 nm and using the molar absorptivity coefficient of 22.000 M-1cm-1. The levels of non-protein thiols will be obtained by the colorimetric method based on the reaction of the sulfhydryl group with 5,5'-dithiobis (2-nitrobenzoic acid) (DTNB). Expressed in mmol/L.

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis.Catalase (Cat) activity was evaluated by the ability of this enzyme to convert H2O2 into O2 and H2O. Expressed in K/gHb.s.

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The activity of superoxide dismutase (SOD) was evaluated based on their ability to inhibit pyrogallol auto-oxidation and promote a decline in absorbance at 420 nm over time. Expressed in U/gHb.

Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The serum levels of triglycerides (TGC), total cholesterol (t-C), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) will be determined using commercial kits (Labtest, Lagoa Santa, MG, Brazil) in a Technicon RA-XT biochemical analyzer (Bayer, New York, NY, USA). Expressed in mg/dL.

The test of one-repetition maximum (1-RM) was adopted to assess muscle strength in all exercises, except for abdominal exercise on the ground, which will be performed only with body mass. Before each test, the subjects will perform a general warm-up (3-5 minutes of light activity), followed by dynamic stretches also for the muscles involved. Then, the participants will perform a specific set of warm-ups that consisted of 8 repetitions with approximately 50% of the estimated load for 1-RM, followed by 3 repetitions with 70% of the estimated load for 1-RM. Subsequently, the loads will be progressively increased until the 1-RM load was found. Rest intervals of approximately 4 to 5 minutes will be inserted between each attempt and the result will be considered valid when performed properly, in a controlled manner, and without assistance from the researchers involved in the assessment. The number of attempts to determine such values will be not more than five. Expressed in kg.

Fat mass (FM) and lean mass (LM) will be measured using a tetrapolar bioimpedance analyzer (InBody230™, Seoul, Korea). Expressed in kg.

Fat mass percentage (BF%) will be measured using a tetrapolar bioimpedance analyzer (InBody230™, Seoul, Korea).

Height was measured in a stadiometer with 0.1 cm accuracy and total body mass was measured using a balance with 0.1 kg accuracy. Body mass index will be calculated using the formula: body mass/height². Expressed in kg/m².

Federal University of Uberlandia

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants randomized to this arm will engage in a 4-week home-based training program with anticipated 12 sessions (3 per week) with participants required to attend a minimum of 9 sessions.

Each session will be performed at home, with resistance bands used to provide resistance. Participants will be guided to increase the resistance if over 15 repetitions can be performed prior to fatigue. Weekly contact will be made with participants to encourage participation and to guide the exercise.

Each session will include:

2 min warm-up jogging on the spot

2 sets of 12-15 repetitions of:

Squats

Hip flexion

Hip extension

Hip abduction

Seated row

Bench press

Lateral raises

2 min jogging on the spot cooldown.

Each session will include:

* 2 min warm-up: jogging on the spot
* Each of the following exercises performed for 60seconds, interspaced by 90 seconds rest

  * Star jumps
  * Standing squats
  * On-the-spot sprints
  * Standing squats
  * Star jumps
* 2 min cool-down: jogging on the spot

Participants will be contacted weekly to encourage participation and to guide the exercise

High-intensity interval training

Jon Lund, MD MBBS

The aim is to investigate the impact of prostate and colorectal cancer on mitochondrial quantity and quality along with muscle mass and function and whether this can be modified through the use of a home-based short-term exercise training program.

The investigators aim to recruit participants awaiting curative surgery for colorectal and prostate cancer and to assess the variation in baseline mitochondrial activity between them.

Participants from both cancer types will then carry out a 4 week home exercise program, this will be randomly allocated to either resistance-based or high-intensity interval training based. Participants will then be re-assessed on the day of their planned surgical procedure to assess the changes effected by the training program.

The investigators hypothesize that there will be variation in mitochondrial activity linked to muscle mass across the two cancer types and that home-based exercise programs have the ability to improve mitochondrial activity along with muscle mass.

Participants will be recruited from surgical outpatient clinics following an initial introduction to the trial by their clinical team. At this point, participants will be provided with a participant information sheet. Contact details will be provided on the information sheet to enable potential participants to arrange a screening visit. The screening visit would entail a detailed description of all study elements and addressing any questions prior to gaining written consent. Once the patient provides written informed consent, they will undergo a full cardiovascular examination by a medically qualified research team member and will have a set of screening bloods taken.

D2O Instructions 24 hours prior to the study day, participants will be asked to consume a stable isotope tracer drink (D2O) at a 3 ml/kg priming dose at home. Participants will be asked to provide saliva samples immediately prior to D2O consumption and a further sample 2-hours post-consumption. Participants will be provided with written instructions, the tracer drinks, and collection receptacles at their screening visit or via postal delivery for them to collect these samples at home. Participants will also be provided with a smaller maintenance dose (1.5ml/kg) to maintain D2O enrichment throughout the training program. This will need to be consumed once per week, with saliva collected immediately prior to, and 2-hours post-consumption each week - again, all materials and written instructions will be provided.

Pre-Exercise study day Participants will attend the University of Nottingham Graduate Entry Medical School at the Royal Derby hospital for an assessment visit prior to the commencement of their training protocol. Participants will be asked to arrive starved from 03:00 of the day, this is to match the nil-by-mouth rules required for their surgical procedure to ensure that all assessments are performed on the same fed-state. On arrival, they will undergo a limited number of physical function assessments (including time up and go, handgrip strength, and the short performance physical battery test).

Followed by the Ruffier test to provide an estimated cardiopulmonary fitness\[14\]. The ruffier test is performed by the participant resting for 5 minutes (lying down) then taking note of the resting heart rate. The participant then performs up to 30 standing squats within 45seconds, with a heart rate taken immediately upon completion. The participant then lies back down for 2 minutes with further heart rate measurement. This allows us to calculate the Ruffier Dicksons index which provides an estimated cardiopulmonary fitness\[15\].

Ruffier Dickson index (RDI): ((P1-70)+ 2(P2-P0))/10 Where P0 is 15 s average resting HR, in our case, from 3 min 45 s to 4 min, P1 is the maximum HR recorded during the first 15 s of recovery, and P2 is the 15 s average after the 1st minute of recovery, that is from 1 min and 00 s and 1 min and 15 s.

An ultrasound scan of the thigh to assess muscle architecture will then be performed.

A muscle biopsy will be taken from the mid-belly of m. vastus lateralis using a conchotome biopsy technique. Biopsies will be taken by medically qualified doctors trained and experienced in this procedure. The procedure will be performed under aseptic conditions. After local anesthetic; a 5-10mm incision will be made in the skin and underlying fascia and a sample of muscle will be taken (approximately 150mg). Direct pressure will be applied to achieve hemostasis. A single absorbable suture will be placed to allow skin apposition and healing. A sterile dressing and compression bandage will be applied to remain in place for the duration of the day. The suture will dissolve around 7-10 days after the biopsy was taken. The biopsy sample will be assessed using an Oroboros respirometer for the primary endpoint of mitochondrial activity, analysed by western blotting, PCR and immunohistochemistry to determine cell signalling and gene expression.

Participants will then be provided with a complimentary snack, and asked to complete quality of life questionnaires (EQ-5D and IPAQ). Participants will be randomly allocated to either the training arm of the study or to routine care at this point. The training regimen will then be demonstrated to them with time allowed for questions regarding the training regimen. This will conclude this study day.

Training program:

All exercise training will take place in the participants own home. With a documentation pack provided to participants to guide exercise and for participants to log their workouts.

Participants will be asked to perform 3 workouts per week over the 4-week period (12 workouts in total) with each workout estimated to take 30 minutes maximum.

Participants randomly allocated to the resistance group will be provided with a set of resistance bands to provide resistance to their workout.

As well as the education session provided at the pre-exercise study day, participants will be contacted weekly via telephone or video call to provide support, encourage participation, answer any difficulties participants maybe experiencing, and to ensure no adverse symptoms are being experienced. A video will be recorded of a member of the research team performing the exercise regimen to enable participants to watch from home.

For participants in the RET arm, the session will include:

2 min warm-up jogging on the spot 2 sets of 12-15 repetitions of: Squats Hip flexion Hip extension Hip abduction Seated row Bench press Lateral raises 2 min jogging on the spot cooldown.

Each exercise will be separated by 1-minute rest, with participants encouraged to workout to mild fatigue on their final repetition in each set. If able to perform more than the allocated maximum of 15 repetitions prior to fatigue, then participants will be informed to increase the resistance by using a tougher resistance band.

For participants in the HIIT arm, the session will include:

2 min warm-up: jogging on the spot Each of the following exercises performed for 60seconds, interspaced by 90 seconds rest Star jumps Standing squats On-the-spot sprints Standing squats Star jumps 2 min cool-down: jogging on the spot

Our research group has conducted many similar exercise regimes of this intensity to subjects in the anticipated age-range without incident. Participants will be advised to terminate exercise training immediately if experiencing:

Chest pain or tightness Faintness Sudden pallor Loss of co-ordination Confusion Dizziness Palpitations Sudden breathlessness

Should any participant experience these effects during any session, they will be advised to seek urgent medical attention and will be withdrawn from the study for safety purposes.

Day of surgery study day All participants will attend for their operations fasted as per the clinical teams' instructions, this is to be starved 6-hours prior to anticipated surgical start time, in line with anesthetic guidelines. Participants will be met by a member of the research team on their arrival, who will perform the following assessments during the time prior to their surgery. Participants will first have an ultrasound scan of the thigh to assess muscle architecture. Following this, participants will be asked to complete a quality-of-life questionnaire (EQ-5D) and a self-administered short-form international physical activity questionnaire (IPAQ). The sputum samples collected at home will be received from the participants by a researcher. Participants will then perform physical function assessments to determine muscle function, including the timed-up-and-go test, and the short performance physical battery test, and the ruffier test to provide an estimated VO2. These assessments will all be completed by a member of the research team prior to the participant being taken to theatre and will not delay a participant's surgical start time, nor will it require participants to arrive earlier than patients not undertaking the study.

Once the participant has been anesthetized for their planned surgical procedure, a member of the research team perform venipuncture to gather samples for analysis of myokine expression, this will be followed by a single muscle biopsy. The muscle biopsy will be taken from the mid belly of m. vastus lateralis using the conchotome biopsy technique as previously described.

Day 21-28 post-surgery Participants will be contacted by postal survey and asked to complete a further EQ-5D and IPAQ questionnaire, along with a study feedback questionnaire to ascertain participants views on the study and their exercise program.

As detailed above, in addition to their normal treatments, patients will potentially undergo the following invasive or potentially harmful tests from involvement in the study (risks outlined in Risk section): three blood tests and 2 muscle biopsies.

Participants will all receive baseline assessments of their mitochondrial function, muscle mass and functional assessments.

Participants with both cancer types (Prostate and colorectal) will be randomly allocated to either Resistance based or high-intensity interval training based home exercises for 4 weeks prior to their planned surgical date.

Participants will then all be re-assessed on the day of their planned surgical procedure.

Due to the nature of the exercise interventions, there will be no masking

Impact of Exercise on Mitochondria in Cancer Patients.

The Impact of Short-term Exercise Programs on Mitochondrial Activity in Colorectal and Prostate Cancer Patients.

Mitochondrial oxidative phosphorylation capacity between colorectal and prostate cancer.

Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. This will then be compared across cancer types and expressed as a ratio of maximal consumption.

The effect of either a resistance exercise-based and high-intensity interval training-based home-based training program on mitochondrial function.

Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes seen throughout the treatment will then be expressed as a percentage in order to express the changes seen from the baseline.

The differing responses between cancer type to the short-term exercise training.

Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes caused by the training regimen will then be expressed as a percentage in order to express the changes seen from the baseline, and in order to allow comparison between cancer type.

As assessed using the short performance physical battery tests. This is a well-established measure of lower extremity physical function, giving a maximal numerary score out of 12 allowing comparison between cancer-types and throughout exercise regimen.

Myokines planned to be analysed: Interleukin - 6, Tumour necrosis factor- alpha, and transforming growth factor beta.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy	NCT00115713	Breast Neoplasm...	Aerobic Exercis... Resistance Exer...	-	University of Alberta, Physical Education
Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy	NCT00115713	Breast Neoplasm...	Aerobic Exercis... Resistance Exer...	-	University of Alberta, Physical Education
Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors	NCT04479098	Breast Neoplasm...	Resistance exer... Exercise detrai...	40 Years - 65 Years	Federal University of Uberlandia
Impact of Exercise on Mitochondria in Cancer Patients.	NCT04558398	Prostate Cancer Colorectal Canc...	Resistance exer... High-intensity ...	50 Years -	University of Nottingham

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