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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by OHSU Knight Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Kerri Winters, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01635413
First received: June 29, 2012
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

To compare the efficacy of distinct exercise programs to prevent falls in women who have completed chemotherapy for cancer, comparing tai chi to strength training, and each against a placebo control group of stretching and relaxation.


Condition Intervention
Neoplasms
Behavioral: Strength Training
Behavioral: Flexibility and Relaxation
Behavioral: Tai Chi

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Change in the number of falls [ Time Frame: Monthly for 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in leg muscle strength [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    The 1-repetition maximum for leg press will be used to determine changes in maximum lower extremity muscle strength. The timed chair stand test will determine changes in functional leg strength so that strength changes can also be interpreted in a clinical context.

  • Change in postural stability [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Postural stability will be determined using the Sensory Organization Test (SOT) to identify balance problems consistent with neuropathy, vestibular loss, and Central Nervous System (CNS) disorders that contribute to fall risk. The composite equilibrium score, the somatosensory ratio, and the vestibular sensory ratio will be used to evaluate the specific effects of the intervention the physiologic systems affected by cancer chemotherapy that impair stability (i.e., neuropathy and vestibular impairment).

  • Change in physical function [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    To evaluate the effects of the different exercise programs on physical functioning, the Physical Performance Battery (PPB) will be assessed across the study period. The PPB consists of 3 timed performance tests: time to rise and sit 5 times from a chair, the time to maintain up to 3 standing positions (tandem, near tandem and side-by-side), and average walking speed over 4 meters.


Estimated Enrollment: 429
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tai Chi
Tai chi training 2 times a week for 6 months.
Behavioral: Tai Chi
The tai chi program will consist primarily of 8 purposeful movement forms, developed on the basis of the original simplified 24-form Yang-style tai chi. The program is moderate intensity and each session will last approximately 45-60 minutes. The program is specifically designed to challenge balance control and train gait patterns, but will not apply additional resistance to movements other than the participant's own body weight.
Experimental: Strength Training
Strength training 2 times a week for 6 months.
Behavioral: Strength Training
The strength training program will consist of 8-10 lower body strengthening exercises performed in sets of 1-3 with 8-15 repetitions at a moderate to vigorous intensity. Participants will wear a weighted vest while performing lower body strengthening exercises using functional movement patterns that challenge balance by using muscle groups and movement involved in everyday activities.
Active Comparator: Flexibility and Relaxation
Flexibility and relaxation training 2 times a week for 6 months.
Behavioral: Flexibility and Relaxation
Flexibility and relaxation training will include a series of whole body flexibility (stretching) and progressive neuromuscular relaxation exercises. Stretches will be performed from a seated or lying position in order to minimize weight-bearing forces that might increase muscle strength or postural control. The stretching will be limited in duration to 15-20 minutes, with the remainder of the 60 minute session devoted to relaxation exercises that produce no neuromuscular stimulus.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635413

Contacts
Contact: Lauren Bumgarner, MS 503-494-4361 mcdonlau@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University School of Nursing Recruiting
Portland, Oregon, United States, 97239
Contact: Lauren Bumgarner, MS    503-494-4361    mcdonlau@ohsu.edu   
Contact       exercise@ohsu.edu   
Sub-Investigator: Lillian Nail, PhD, RN         
Sub-Investigator: Shiuh-Wen Luoh, MD         
Sub-Investigator: Fay Horak, PhD         
Sub-Investigator: Jill Bennett, PhD         
Sub-Investigator: Fuzhong Li, PhD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Kerri Winters-Stone, PhD Oregon Health and Science University
  More Information

No publications provided by OHSU Knight Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kerri Winters, Associate Professor and Associate Scientist, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01635413     History of Changes
Other Study ID Numbers: 8560, 1 R01 CA163474-01
Study First Received: June 29, 2012
Last Updated: March 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
cancer survivor
exercise
neoplasms
postmenopause
randomized controlled trial
women
falls
physical function
muscle strength
postural stability

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014