Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
The purpose of the study is to compare the efficacy of two very distinct types of exercise,
tai chi versus strength training, to prevent falls in women who have completed chemotherapy
for cancer. The study is a three-group, single-blind, parallel design, randomized controlled
trial in women, aged 50-75 years old, who have completed chemotherapy for cancer comparing
1) tai chi to 2) strength training against 3) a placebo control group of seated stretching
exercise. Women participate in supervised study programs two times per week for six months
and are followed for an additional six months after formal training stops. The specific aims
of this study are to: 1) Determine and compare the efficacy of both tai chi training and
strength training to reduce falls in older female cancer survivors, 2) Determine the
mechanism(s) by which tai chi and strength training each reduces falls by measuring changes
in muscle strength and postural stability across the study period and, 3) Determine whether
or not the benefits of each intervention last after structured training stops by repeating
measures six months after training ends. If the aims are successfully achieved, findings
from this study will not only generate new knowledge about the effectiveness of two
exercise-based treatment options to reduce falls after cancer but will also advance clinical
rehabilitative practice. These factors, combined with the fact that the two exercise
regimens are easily accessible and implementable in practice, increase the potential impact
of this research on the quality of life in women with cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Change in the number of falls
In this study, 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. The study will track the number of falls, the number of injurious falls, and medical care resulting from a fall during the intervention and follow-up periods.
Monthly for 12 months
Yes
Kerri Winters-Stone, PhD
Principal Investigator
Oregon Health and Science University
United States: Institutional Review Board
8560
NCT01635413
January 2013
September 2016
Name | Location |
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Oregon Health & Science University School of Nursing | Portland, Oregon 97239 |