Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
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Identifiers
Details and patient eligibility
About
This research is being done to compare the physical and quality of life benefits of two different types of exercise- tai chi versus strength training- for female cancer survivors who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to participants in a group that performs flexibility and relaxation exercises, which is expected to have different benefits than either tai chi or strength training.
Full description
PRIMARY OBJECTIVES:
I. Compare the relative efficacy of tai chi and strength training to prevent falls in female cancer survivors.
II. Determine the mechanism by which tai chi and strength training each reduces the risk of falls.
III. Determine how well the benefits of each intervention persist after structured training stops.
SECONDARY OBJECTIVE:
I. Evaluate the effect of the intervention on physical functioning.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients attend strength training classes for 1 hour 2 days per week.
ARM II: Patients attend tai chi classes for 1 hour 2 days per week.
ARM III: Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
In all arms, treatment continues for 6 months.
After completion of study treatment, patients are followed up for 6 months.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm either the site of her cancer or that her stage of cancer is < stage IV, we will send a letter to her physician to confirm this criterion)
- Completed chemotherapy > 3 months prior to enrollment and no concurrent adjuvant therapy other than hormone manipulation therapy for breast cancer (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm whether or not she completed chemotherapy 3 months prior to enrollment, we will send a letter to her physician to confirm eligibility on this criterion)
- Postmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent [< 6 months from enrollment] laboratory report documenting serum follicle-stimulating hormone [FSH] > 30 mIU/ml and/or serum estradiol < 30 pg/ml)
- Currently underactive (< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire)
Exclusion criteria
- Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone)
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)
Trial design
Primary purpose
Allocation
Interventional model
Masking
444 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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