Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)

Conditions
-----------------
Postmenopausal, Malignant Neoplasm

Intervention / Treatment
-----------------
* Behavioral: Exercise Intervention
* Behavioral: Exercise Intervention
* Behavioral: Exercise Intervention
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (strength training)<br>Patients attend strength training classes for 1 hour 2 days per week. | Behavioral: Exercise Intervention<br>* Undergo strength training classes<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (tai chi)<br>Patients attend tai chi classes for 1 hour 2 days per week. | Behavioral: Exercise Intervention<br>* Undergo tai chi classes<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm III (control)<br>Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week. | Behavioral: Exercise Intervention<br>* Undergo stretching and relaxation classes<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Prospective assessment of falls will be done by collecting monthly and quarterly reports returned by postal and/or electronic mail. A fall is defined as unintentionally coming to rest on the ground or at some other lower level, not as a result of a major intrinsic event (e.g., stroke or syncope) or overwhelming hazard. | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Measured by 1-repetition maximum (1-RM) for leg press. The maximum amount of weight that can be lifted one time. | Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment | 
| Postural stability | Measured by Computerized dynamic posturography using the sensory organization test (SOT) and limits of stability (LOS). The SOT generates an equilibrium scores and sensory ratios that range from 0-100, where 100 = perfect stability and 0 = an inability to maintain balance and a fall. The LOS measures the average % of targeted distances reached (end point excursion) and average % of movement in the targeted direction (directional control). | Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment | 
| Flexibility | Measured by the standardized chair sit-and-reach test for lower body flexibility. Designed for older adults with demonstrated validity and reliability in older adults (test-retest 0.95-0.96). | Baseline, 3 and 6 months during study treatment and 6 months after completion of study | 
| Physical Function | Measured by the Physical Performance Battery (PPB). The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12. | Baseline, 3 and 6 months during study treatment and 6 months after completion of study | 
| Injurious falls | Collected during prospective monthly and quarterly reports of falls. A fall is considered ''injurious'' if it results in fractures, head injuries, sprains, bruises, scrapes, or serious joint injuries, or if the participant seeks medical care. | Baseline up to 12 months |