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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635413
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kerri Winters, OHSU Knight Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Postmenopausal Behavioral: Exercise Intervention Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
Study Start Date : September 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Arm I (strength training)
Patients attend strength training classes for 1 hour 2 days per week.
Behavioral: Exercise Intervention
Undergo strength training classes

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (tai chi)
Patients attend tai chi classes for 1 hour 2 days per week.
Behavioral: Exercise Intervention
Undergo tai chi classes

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm III (control)
Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
Behavioral: Exercise Intervention
Undergo stretching and relaxation classes

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Falls [ Time Frame: Baseline up to 12 months ]
    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.


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment ]
    Measured by 1-repetition maximum (1-RM) for leg press. The maximum amount of weight that can be lifted one time.

  2. Postural stability [ Time Frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment ]
    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).

  3. Flexibility [ Time Frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study ]
    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).

  4. Physical Function [ Time Frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study ]
    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.

  5. Injurious falls [ Time Frame: Baseline up to 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635413


Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kerri Winters-Stone OHSU Knight Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kerri Winters, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01635413    
Other Study ID Numbers: IRB00008560
NCI-2012-01141 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MR00045870
CPC-12080-LX
IRB00008560 ( Other Identifier: OHSU Knight Cancer Institute )
R01CA163474 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Neoplasms