Walking Exercise for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Antibiotics, Probiotics, Nicotinamide

Disqualifiers: Cognitive impairment, Neurologic disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have taken antibiotics or probiotics within 4 weeks of screening.

What data supports the effectiveness of the treatment Walking Exercise for Breast Cancer?

Research shows that home-based exercise programs, including walking, are effective in improving physical activity and overall health for breast cancer survivors. These programs are convenient and affordable, helping women maintain a healthy lifestyle after completing primary therapy. ^{1 2 3 4 5}

Is walking exercise generally safe for humans?

Research on home-based exercise programs for people with intermittent claudication (a condition related to peripheral artery disease) shows that these programs are generally safe, with a very low rate of adverse events. This suggests that walking exercise is likely safe for humans in general. ^{6 7 8 9 10}

How is the Walking Exercise treatment for breast cancer different from other treatments?

The Walking Exercise treatment for breast cancer is unique because it offers both center-based and home-based options, making it a flexible and convenient way for survivors to increase physical activity and improve their quality of life. This approach is particularly beneficial as it can be easily integrated into daily routines, unlike more traditional, facility-based exercise programs. ^{1 2 4 11 12}

Research Team

Stephen Anton

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for older breast cancer survivors, aged 60 or above, who finished their cancer therapy between 3 months and a year ago. Participants must have had stage I-III invasive breast cancer diagnosed in 2021 or 2022 and be experiencing moderate to severe fatigue. They should not have any major health issues that could interfere with exercise.

Inclusion Criteria

I finished my additional cancer treatment between 3 months and 1 year ago.

I often feel very tired.

Your cancer was diagnosed in 2021 or 2022.

Exclusion Criteria

You have other health problems that could make it difficult for you to take part in the exercise program.

Pregnant

Simultaneous participation in other interventional studies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either a center-based or home-based walking exercise intervention for 8 weeks

8 weeks

3 visits per week (center-based) or 5 sessions per week (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Center-Based Walking Exercise
• Home-Based Walking Exercise

Trial Overview The EXERGISE study is testing whether walking exercises can help reduce fatigue in older breast cancer survivors. It compares two types of walking programs: one that's done at a center under supervision and another that participants can do at home on their own.

Participant Groups

Group I: Home-Based Walking Exercise Experimental Treatment 1 Intervention

Subjects will be randomly assigned to walk for exercise in their community five days/week.

Group II: Center-Based Walking Exercise Experimental Treatment 1 Intervention

Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

A home-based exercise program for breast cancer survivors significantly improved upper body strength and shoulder range of motion after 16 weeks, involving 89 women aged around 55 years.

However, the intervention did not lead to significant changes in overall physical fitness, sedentary behavior, or disability measures, suggesting that additional strategies may be needed to enhance broader health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. Ortiz, A., Hughes, DC., Mama, SK., et al.[2022]

Home-based physical activity interventions are effective in increasing physical activity levels among breast cancer survivors who have completed primary therapy, as shown in a review of 20 studies including randomized controlled trials.

These interventions, such as walking programs, provide a convenient and affordable way for breast cancer survivors to improve their quality of life and maintain a healthy lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of home-based physical activity interventions for breast cancer survivors. Coughlin, SS., Caplan, L., Stone, R., et al.[2020]

A supervised exercise program for breast cancer survivors showed significant improvements in motivational factors related to exercise, particularly in autonomy, with a notable increase in the immediate exercise group compared to the delayed group.

The study involved 60 participants and achieved a 61.3% adherence rate, suggesting that early engagement in exercise can foster a positive attitude towards physical activity, potentially leading to better long-term adherence post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a combined resistance and aerobic exercise program on motivational variables in breast cancer survivors: a randomized controlled trial. Milne, HM., Wallman, KE., Gordon, S., et al.[2018]

A home-based exercise program for breast cancer survivors significantly improved their quality of life and physical activity levels, with participants increasing their exercise from an average of 40.7 minutes per week to 116.9 minutes by week 12.

The intervention led to notable improvements in global quality of life, social functioning, and physical fitness, as measured by predicted VO2 peak, demonstrating its effectiveness in a population lacking access to specialized exercise facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based exercise in breast cancer survivors: a randomized clinical trial. Farajivafa, V., Khosravi, N., Rezaee, N., et al.[2023]

The home-based exercise (HBE) rehabilitation program significantly improved shoulder flexion and abduction range of motion in women after surgery for breast cancer, compared to usual care, indicating its efficacy in post-surgical recovery.

The program was conducted over 11 days post-surgery and showed no differences in shoulder strength between groups, but both groups experienced improvements in external rotation and grip strength, suggesting that while mobility improved with HBE, strength gains were similar across both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a self-administered, home-based exercise rehabilitation program for women following a modified radical mastectomy and axillary node dissection: a preliminary study. Kilgour, RD., Jones, DH., Keyserlingk, JR.[2022]

Home-based exercise programs (HBEPs) for individuals with intermittent claudication (IC) are safe, with only four adverse events reported over 147,810 patient-hours, resulting in a complication rate of one event per 36,953 patient-hours.

Most adverse events were cardiac-related and occurred during high levels of claudication pain, suggesting that while HBEPs are generally safe, monitoring and possibly cardiac screening may be beneficial for those engaging in more intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. Waddell, A., Seed, S., Broom, DR., et al.[2022]

Supervised exercise therapy (SET) significantly improves maximal walking distance (MWD) and pain-free walking distance (PFWD) in patients with intermittent claudication compared to home-based exercise therapy (HBET) and walking advice (WA), with increases of approximately 120 and 210 meters after three months, respectively.

SET shows better outcomes for self-reported functional impairment and some quality of life measures compared to WA, while HBET does not demonstrate significant improvements over WA, indicating that SET is the most effective exercise intervention for enhancing walking capacity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication. Hageman, D., Fokkenrood, HJ., Gommans, LN., et al.[2022]

In a study of 20 patients with peripheral artery disease (PAD) participating in a 12-week community-based structured exercise training program, non-exercise walking (NEW) activity was found to have a moderate positive correlation with improvements in peak walking time (PWT), suggesting that everyday walking can enhance exercise performance.

The results indicate that increasing walking activity outside of formal exercise sessions may be beneficial for PAD patients, highlighting the importance of overall physical activity in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of non-exercise walking activity with exercise performance in patients with peripheral artery disease: NEW activity for PAD. Mays, RJ., Kahnke, R., Schorr, EN., et al.[2023]

Home-based exercise therapy (HBET) can improve functional walking capacity and quality of life in patients with peripheral arterial disease (PAD) and intermittent claudication (IC), based on a systematic review of 7 randomized controlled trials involving 754 patients.

While HBET is beneficial compared to no exercise, supervised exercise therapy (SET) remains the more effective treatment option for enhancing walking capacity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise Therapy in the Management of Intermittent Claudication: A Systematic Review and Meta-Analysis. Twomey, A., Khan, Z.[2023]

A supervised exercise program significantly improved initial claudication distance (ICD) more than a home-based program after 12 weeks, indicating that structured guidance can enhance short-term outcomes for patients with intermittent leg claudication.

Both supervised and home-based exercise programs led to similar long-term improvements in absolute claudication distance (ACD) after 24 weeks, suggesting that a well-instructed home-based program can be a safe and effective alternative for maintaining exercise benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home versus supervised exercise for patients with intermittent claudication. Savage, P., Ricci, MA., Lynn, M., et al.[2022]

A 12-week exercise training program with follow-up phone calls significantly increased the number of 'very active' women and overall physical activity levels in the intervention group of 31 women recovering from breast cancer surgery, compared to a control group.

The increased physical activity was associated with improved quality of life, particularly in the 'future healthy function' area, although some symptoms related to treatment side effects did increase, indicating a complex relationship between exercise and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training and follow-up calls at home on physical activity and quality of life after a mastectomy. Nemli, A., Tekinsoy Kartin, P.[2019]

A systematic review of 27 studies found that demonstrating how to perform physical activity was the most commonly used behavior change technique (BCT) among interventions aimed at increasing activity levels in breast cancer survivors.

The use of objects like pedometers or accelerometers was identified as the BCT with the highest potential to boost physical activity, followed by goal setting and self-monitoring, highlighting effective strategies for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of behaviour change techniques used in interventions to increase physical activity among breast cancer survivors. Hailey, V., Rojas-Garcia, A., Kassianos, AP.[2022]

References

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

Effectiveness of a Home-Based Exercise Intervention in the Fitness Profile of Hispanic Survivors of Breast Cancer. [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

A review of home-based physical activity interventions for breast cancer survivors. [2020]

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

Impact of a combined resistance and aerobic exercise program on motivational variables in breast cancer survivors: a randomized controlled trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based exercise in breast cancer survivors: a randomized clinical trial. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of a self-administered, home-based exercise rehabilitation program for women following a modified radical mastectomy and axillary node dissection: a preliminary study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication. [2022]

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

Relation of non-exercise walking activity with exercise performance in patients with peripheral artery disease: NEW activity for PAD. [2023]

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

Home-Based Exercise Therapy in the Management of Intermittent Claudication: A Systematic Review and Meta-Analysis. [2023]

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

Effects of home versus supervised exercise for patients with intermittent claudication. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Effects of exercise training and follow-up calls at home on physical activity and quality of life after a mastectomy. [2019]

12. Japan pubmed.ncbi.nlm.nih.gov

A systematic review of behaviour change techniques used in interventions to increase physical activity among breast cancer survivors. [2022]