Breast Cancer Clinical Trial
Official title:
The Effect of Resistance Exercise Frequency in Breast and Gynecologic Cancer Survivors
Verified date | June 2015 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
Canada | Exercise Lab: Queen Elizabeth II Dickson Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority | Dalhousie University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | 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) | Yes |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
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