Exercise Program for Cancer Management

(WELL-FIT Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Waterloo

Disqualifiers: Physical limitations, No medical clearance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a combination of cardiovascular (heart and lung exercises) and resistance (strength) exercises can manage side effects of cancer treatments. Participants will join the UW WELL-FIT Exercise Program, a 12-week regimen designed to address issues like fatigue and weakness associated with cancer therapies. The findings could provide valuable insights into existing research on cancer care. Individuals diagnosed with cancer and undergoing chemotherapy, radiation, or hormonal therapy might be suitable for this trial. Medical clearance is required to participate in exercise activities. As an unphased trial, this study offers a unique opportunity to enhance the understanding of exercise benefits during cancer treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current cancer treatments while participating.

What prior data suggests that this exercise program is safe for cancer management?

Research shows that exercise is safe for people undergoing cancer treatment. One study with 577 participants found that exercise did not cause any serious harm. Coaches observed minor side effects in 20% of cases, indicating that most people did not experience problems from exercising. Programs like UW WELL-FIT aim to improve physical ability and quality of life. They appear promising in safely managing treatment side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the UW WELL-FIT Exercise Program because it offers a non-traditional approach to cancer management by focusing on cardiovascular and strength training exercises. Unlike standard treatments that often rely on medication or surgery, this program emphasizes physical activity as a way to improve overall health and potentially enhance recovery. The unique feature of this program is its structured 24-session regimen over approximately 12 weeks, which aims to boost patients' physical strength and cardiovascular health, potentially improving their quality of life and treatment outcomes. This holistic approach encourages an active lifestyle, which may complement existing treatments and provide additional benefits not achieved through conventional methods alone.

What evidence suggests that the UW WELL-FIT Exercise Program is effective for managing cancer treatment side effects?

Research has shown that the UW WELL-FIT Exercise Program, which participants in this trial will undergo, can help manage the side effects of cancer treatment. Studies have found that supervised exercise can boost physical abilities and improve the quality of life for cancer patients. This program includes exercises for the heart and muscles, which contribute to better overall health. Patients in these programs often report feeling stronger and having more energy. These findings suggest that exercise can play a crucial role in managing the side effects of cancer treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Marina Mourtzakis, PhD

Principal Investigator

University of Waterloo

Caryl Russell, MSc

Principal Investigator

University of Waterloo

Michael Sharratt, PhD

Principal Investigator

University of Waterloo

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with cancer and are currently undergoing treatment such as chemotherapy, radiation therapy, or hormonal therapy. Participants must be able to exercise and have their doctor's approval to join.

Inclusion Criteria

I am currently undergoing treatment for my cancer.

Exclusion Criteria

Lack of medical clearance from physician

Physical/health factors that prohibit exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

Participants undergo initial consultation, assessment, and consent process

1-2 weeks

1 visit (in-person)

Treatment

Participants engage in a 12-week exercise program with cardiovascular and strength training

12 weeks

24 sessions (in-person)

Post Assessment

Post assessment including repeated pre-test assessments and data entry

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Graduate Program (optional)

Participants may opt into the UW WELL-FIT Graduate Program for continued exercise and annual reassessments

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• UW WELL-FIT Exercise Program

Trial Overview The UW WELL-FIT program is testing the effectiveness of cardiovascular and resistance exercises combined with educational sessions in managing side effects of cancer treatments. The outcomes will contribute to ongoing research.

How Is the Trial Designed?

Group I: Cardiovascular and strength training exercise Experimental Treatment 1 Intervention

24 sessions (\~12 weeks) exercise

Who Is Running the Clinical Trial?

University of Waterloo

Lead Sponsor

Trials

132

Recruited

221,000+

Published Research Related to This Trial

The EFICANCER individualized exercise program significantly improved cancer-specific quality of life and functional capacity in patients with stage IV gastrointestinal, breast, or non-small cell lung cancer, with a notable difference of 15.7 points in quality of life scores after 12 months.

The program was found to be safe and feasible, with 74.47% of participants completing at least one session, highlighting its potential as a valuable addition to standard oncological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. Mendizabal-Gallastegui, N., Arietaleanizbeaskoa, MS., Latorre, PM., et al.[2023]

A study of 350 cancer patients receiving physical therapist-led exercise counseling showed significant reductions in global distress and fatigue, indicating that exercise counseling can effectively improve symptoms related to cancer treatment.

Patients reported notable improvements in overall health and well-being after counseling, suggesting that exercise may play a crucial role in enhancing quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapist-Led Exercise Assessment and Counseling in Integrative Cancer Care: Effects on Patient Self-reported Symptoms and Quality of Life. Lopez, G., Eddy, C., Liu, W., et al.[2023]

In a study involving 577 participants undergoing cancer treatment, exercise was found to be safe, with 20% of adverse events (AEs) reported by coaches and 28% by participants, mostly being minor musculoskeletal issues.

High-intensity exercise was associated with a higher likelihood of AEs compared to low-to-moderate exercise, but both forms of exercise are recommended for patients if there are no medical contraindications, as serious complications like lymphedema and PICC issues were low and not significantly different across exercise intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it safe to exercise during oncological treatment? A study of adverse events during endurance and resistance training - data from the Phys-Can study. Henriksson, A., Johansson, B., Radu, C., et al.[2021]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

The Bizi Orain exercise program, a community-based initiative for cancer patients, aims to improve cardiorespiratory function and quality of life through a 3-month supervised exercise regimen, with 265 patients enrolled since January 2019.

This program is significant as it represents the first population-based exercise initiative in Spain designed to integrate structured physical activity into cancer care, potentially enhancing patient survival and reducing treatment-related adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial. Arietaleanizbeaskoa, MS., Gil Rey, E., Mendizabal Gallastegui, N., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21562800/

UW WELL-FIT: the impact of supervised exercise programs ... Purpose: The purpose of this study is to report physical function and quality of life data collected from cancer patients who participated ...

2. researchgate.net researchgate.net/publication/51117704_UW_WELL-FIT_The_impact_of_supervised_exercise_programs_on_physical_capacity_and_quality_of_life_in_individuals_receiving_treatment_for_cancer

The impact of supervised exercise programs on physical ... The purpose of this study is to report physical function and quality of life data collected from cancer patients who participated in a supervised exercise ...

3. uwaterloo.ca uwaterloo.ca/centre-community-clinical-applied-research-excellence/programs/community-programs/uw-well-fit-cancer-exercise-programs

UW WELL-FIT cancer exercise programs UW WELL-FIT is a portfolio of evidence-based exercise programs for individuals who are currently or have previously undergone cancer treatment.

4. withpower.com withpower.com/trial/phase-5-2014-3d5e2

Exercise Program for Cancer Management (WELL-FIT Trial) The purpose of this project is to help to manage the many cancer treatment side effects through cardiovascular and resistance exercise, and education with the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0003999321013484

Community-Based Exercise Programs for Cancer Survivors UW WELL-FIT: the impact of supervised exercise programs on physical capacity and quality of life in individuals receiving treatment for cancer. Support Care ...