Strength Training Study for Survivors of Breast and Gynecologic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare once-a-week vs. twice-a-week strength training in survivors of breast and gynecologic cancer to determine which is the optimal exercise prescription.

Detailed Description
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As a result of cancer and its treatment, survivors of breast and gynecologic cancer are reported to have deficits in both physical and psycho-social health. In cancer survivors exercise has been shown to improve fitness, increase bone density and lean body mass, enhance self-esteem, and reduce fatigue. These changes have a positive effect on the survivor's physical functioning and quality of life. However, there are few studies which have examined the effects of strength training or studies aimed at determining optimal exercise prescription in this population. Therefore, the purpose of this study is to compare two strength training prescriptions (once-a-week vs. twice-a-week strength training) to determine which prescription (if any) results in greater benefit for survivors. It is hoped that the results of this study will lead to a better understanding of how strength training improves the health of survivors and will help inform future exercise guidelines for this population.

Official Title
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The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors

Conditions
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Breast Cancer, Gynecologic Cancer, Ovarian Cancer, Uterine Cancer, Cervical Cancer

Intervention / Treatment
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* Behavioral: Strength Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Survivor of Breast or Gynecologic Cancer Completed Primary Treatment (hormone treatments are ok) 18 years of age or older Physician's Permission to Participate Exclusion Criteria: High Risk Individuals (determined by questionnaire) Secondary Health Problems that could increase the risk of participating (Includes but not limited to: Uncontrolled angina/hypertension, heart failure, osteoporosis, brain metastases, history of seizures). Report participating in a strength training program in the past six (6) months Have had a change in medication in the past 30 days

Ages Eligible for Study
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Minimum Age: 18 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once-a-week Strength Training<br>After completing the introduction to strength training (two sessions in the first week), participants randomized to the once-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet ONCE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises. | Behavioral: Strength Training<br>* This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.<br>* Other names: Restive Exercise;|
| Experimental: Twice-a-week Strength Training<br>After completing the introduction to strength training (two sessions in the first week), participants randomized to the twice-a-week group will receive 12 additional weeks of progressive strength training. Participants will meet TWICE-A-WEEK to strength train in a supervised exercise group. The program includes nine exercises. | Behavioral: Strength Training<br>* This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.<br>* Other names: Restive Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Muscular Strength | Muscular Strength will be assessed using the predicted one-repetition maximum method (Brzycki method)using the bench press and leg press to measure upper and lower body strength. | Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process Measures | Process measures will provide insight about the feasibility of the exercise prescriptions. Included measures are: recruitment (percent of interested survivors who consent); adherence (the number of sessions attended); compliance (the degree to which the survivors follow the exercise prescription); and safety (all adverse events will be recorded) | Final (end of week 13) | 
| Changes in Muscular Endurance | Muscular Endurance will be assessed using the standard load test. Participants will lift a weight equal to 50% one repetition maximum as many times as possible. The bench press and leg press will be used to measure endurance of the upper and lower body. | Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) | 
| Changes in Body Composition | Body composition will be assessed using bioelectric impedance to determine percent body fat, lean body mass, and fat mass. | Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) | 
| Changes in Quality of Life | Quality of Life will be assessed using the Medical Outcomes Survey - Short Form. This survey measures multiple aspects of quality of life including: physical function, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, and mental health. | Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) | 
| Changes in Fatigue | Fatigue will me measured using the Fatigue scale of the Functional Assessment of Cancer Treatment. This is a 13 item questionnaire that measures the degree to which a cancer survivor experiences fatigue | Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) | 
| Changes in Physical Activity Levels | Physical activity will be estimated using the Godin Leisure Time Exercise Questionnaire. | Baseline (end of week 1); Midpoint (end of week 7); Final (end of week 13) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Breast Cancer, Gynecologic Cancer, Strength Training, Exercise, Physical Activity, Fatigue, Quality of Life, Strength, Fitness, Cancer Survivor, Survivor