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

200 Participants Needed

Trial Summary

What is the purpose of this 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 goal of using program outcomes to contribute to current research.

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 data supports the effectiveness of the UW WELL-FIT Exercise Program treatment for cancer management?

Research shows that supervised exercise programs like UW WELL-FIT can improve physical function and quality of life for cancer patients. Exercise has been found to help with various quality-of-life aspects and can be safely integrated into cancer care, even for those with advanced cancer. ^{1 2 3 4 5}

Is exercise safe for people undergoing cancer treatment?

Research shows that exercise is generally safe for people undergoing cancer treatment, with some studies monitoring adverse events (unwanted effects) and finding them to be relatively low. Exercise programs have been shown to improve fitness in cancer patients, and while potential harms are less studied, guidelines are being developed to better understand and report any negative effects. ^{4 6 7 8 9}

How does the exercise program treatment for cancer differ from other treatments?

This exercise program is unique because it integrates supervised physical activity into cancer care, focusing on improving physical function and quality of life, rather than directly targeting cancer cells like traditional treatments such as chemotherapy or radiation. ^{1 2 10 11 12}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

UW WELL-FIT: the impact of supervised exercise programs on physical capacity and quality of life in individuals receiving treatment for cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Safety, feasibility, and effectiveness of implementing supervised exercise into the clinical care of individuals with advanced cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Coping with cancer: can exercise help? [2010]

4. Canada pubmed.ncbi.nlm.nih.gov

Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial. [2021]

5. United States 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. [2023]

6. England 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Safety, Effectiveness, and Uptake of Exercise Medicine Integrated Within a Cancer Care Center. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Nurse-Supervised Exercise for People with Stage IV Cancer: The EFICANCER Randomized Clinical Trial. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Feasibility and impact of a physical exercise program in patients with advanced cancer: a pilot study. [2019]