Strength Training for Older Breast Cancer Survivors

Study Overview
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Brief Summary
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Women aged 50 and older are disproportionately affected by breast cancer, not only in terms of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a first diagnosis of breast cancer are aged 50 and over, thus older women constitute the largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether physical activity and exercise interventions affect long-term symptoms, physical fitness and function, and body composition of older breast cancer survivors. Due to the combined effects of breast cancer, related treatments and aging it is likely that exercise is even more beneficial for older breast cancer survivors than for younger survivors. Along with the cancer-related symptom of fatigue common to cancer survivors, older survivors face age-related declines in bone and muscle mass, muscle strength, bone health and physical function (gait and balance) that are likely exacerbated by reduced physical activity in survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training is specifically suited to reverse or slow age-related declines in bone, muscle, strength and function and has shown promise to reduce cancer-related fatigue. However, no controlled trials of strength training in older breast cancer survivors have been conducted.

Official Title
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Strength Training for Older Breast Cancer Survivors

Conditions
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Breast Neoplasm, Osteoporosis, Postmenopausal

Intervention / Treatment
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* Behavioral: Resistance Exercise
* Behavioral: Flexibility Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with early stage breast cancer at age of 50 or older Completed adjuvant therapy, radiation +/- chemotherapy but selective estrogen receptor modulators (SERMS), (aromatase inhibitors (AIs) ok) at least 1 year prior to enrollment Exclusion Criteria: Cognitive difficulties that preclude answering the survey questions, participating in performance testing or giving informed consent Diagnosed osteoporosis Current regular participation in planned impact activities or resistance training (more than 2 times a week for 30 minutes at a time) Medication that contraindicates participation in moderate intensity strength training or previous use of medications known to affect bone metabolism Movement or neurologic disorder, not including chemo-induced peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Progressive resistance training program 3 times a week for 12 months | Behavioral: Resistance Exercise<br>* 60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months<br>|
| Active Comparator: 2<br>Flexibility training 3 times a week for 12 months | Behavioral: Flexibility Training<br>* 60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning (muscle strength, gait and balance), self-report physical and mental health, and fatigue |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (fat mass, muscle mass) and bone mineral density of the lumbar spine and proximal femur |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms