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


N/A
50 Years
75 Years
Open (Enrolling)
Female
Neoplasms

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Trial Information

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.


Inclusion Criteria:



- Diagnosed with stage I-IIIc cancer other than cancers of the brain or spinal cord

- Completed chemotherapy more than 3 months prior to enrollment and no concurrent
adjuvant therapy other than hormone manipulation therapy for breast cancer

- Postmenopausal

- Currently underactive (less than 60 minutes of moderate intensity exercise per week
in the last month)

Exclusion Criteria:

- Cognitive difficulties that preclude answering the survey questions, participating in
the exercise classes or performance tests, or providing informed consent

- A medical condition, movement or neurological disorder, or medication use that
contraindicates participation in moderate intensity exercise

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Change in the number of falls

Outcome Description:

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.

Outcome Time Frame:

Monthly for 12 months

Safety Issue:

Yes

Principal Investigator

Kerri Winters-Stone, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

8560

NCT ID:

NCT01635413

Start Date:

January 2013

Completion Date:

September 2016

Related Keywords:

  • Neoplasms
  • cancer survivor
  • exercise
  • neoplasms
  • postmenopause
  • randomized controlled trial
  • women
  • falls
  • physical function
  • muscle strength
  • postural stability
  • Neoplasms

Name

Location

Oregon Health & Science University School of Nursing Portland, Oregon  97239