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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01635413
First received: June 29, 2012
Last updated: June 24, 2015
Last verified: June 2015
  Purpose

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 Intervention
Malignant Neoplasm
Behavioral: Exercise Intervention
Other: Laboratory Biomarker Analysis

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:
  • Benefits of treatment after completion of structured training [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Evaluated with a negative binomial regression model using an intent-to-treat approach. The regression will be performed piecewise, with the change point occurring at 6 months. In addition, we will examine whether participation in an exercise program following the end of the intervention moderates the effect of the intervention on stability, strength, and falls.

  • Muscle strength and postural stability as mediators between interventions and falls [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Analyzed using structural equation modeling. Manifest model tested with dummy vectors representing tai chi and strength training as exogenous variables, baseline scores of strength (1-RM) and stability (composite SOT score) as exogenous control variables, strength and stability (difference from baseline-6 months) as endogenous variables, and # of falls from baseline to end of intervention as endogenous variable. Analysis also performed replacing composite SOT score with somatosensory (SOM) and vestibular (VEST) scores, and 1-RM and composite SOT with strength measures (PPB chair stand) and dynamic stability (gait speed).

  • Total number of falls per participant in strength training and tai chi arms compared to control [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Compared between groups while controlling for covariates using negative binomial regression models of total number of falls per participant during the intervention period. A negative binomial regression was chosen over a Poisson regression for modeling the count data because of the over dispersion that is common with actual research data. Intervention type will be entered into the model as 2 dummy vectors, with the reference group being the control group. Fall rates for participants who drop out of the study will be adjusted by accounting for their exposure time within the study timeframe.


Secondary Outcome Measures:
  • Effectiveness of interventions in breast cancer survivors (BCS) compared with women with other cancers [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Using the negative binomial regression models, we will include the binary BCS variable and the product of binary BCS and the treatment dummy vectors as independent variables. A significant coefficient for the product term would indicate that having breast cancer versus other types modifies the effect of the intervention on the fall rate. All significant interactions will be plotted to determine the nature of the interactions.

  • Reduction in injurious falls, defined as any fall that resulted in fractures, head injuries, sprains, bruises, scrapes, or serious joint injuries, or in a participant seeking outside medical attention, in patients with at least 1 previous fall [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    This analysis will be conducted among the subsample that had at least 1 fall using logistic regression. The control variables and dummy vectors for treatment will be the independent variables and the occurrence of at least 1 injurious fall will be the binary dependent variable.


Other Outcome Measures:
  • Effect of tai chi and resistance exercise on biomarkers common to both cancer progression and CVD [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Will be tested with a linear mixed effects modeling approach. Specific hypotheses about treatment group effects will be examined through a series of planned contrasts. In addition to evaluating hypotheses based on traditional significance levels, the practical significance of the interventions will be evaluated, and any interaction effects will be interpreted, by summarizing results with respect to effect size.

  • Effect of tai chi and resistance exercise on biomarkers unique to CVD [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Will be tested with a linear mixed effects modeling approach. Specific hypotheses about treatment group effects will be examined through a series of planned contrasts. In addition to evaluating hypotheses based on traditional significance levels, the practical significance of the interventions will be evaluated, and any interaction effects will be interpreted, by summarizing results with respect to effect size.

  • Effects of exercise training on a biomarker of accelerated aging [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Will be tested with a linear mixed effects modeling approach. Specific hypotheses about treatment group effects will be examined through a series of planned contrasts. In addition to evaluating hypotheses based on traditional significance levels, the practical significance of the interventions will be evaluated, and any interaction effects will be interpreted, by summarizing results with respect to effect size.

  • Influence of initial and change in adiposity on changes in biomarkers from exercise [ Time Frame: Up to 6 months after completion of study treatment ] [ Designated as safety issue: No ]
    Will be tested with a linear mixed effects modeling approach with interaction terms added. Significant interaction terms will indicate that the effect of the exercise intervention depends, or is moderated by, the level of participant body fat at baseline. In addition to evaluating hypotheses based on traditional significance levels, the practical significance of the interventions will be evaluated, and any interaction effects will be interpreted, by summarizing results with respect to effect size.


Estimated Enrollment: 481
Study Start Date: September 2012
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Laboratory Biomarker Analysis
Optional correlative 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: Laboratory Biomarker Analysis
Optional correlative 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: Laboratory Biomarker Analysis
Optional correlative studies

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 OBJECTIVES:

I. Quantify and compare the relative efficacy of tai chi and resistance exercise on biomarkers common to both cancer progression and cardiovascular disease (CVD) in women cancer survivors. (Optional ancillary study) II. Quantify and compare the relative efficacy of tai chi and resistance exercise on biomarkers unique to CVD in women cancer survivors. (Optional ancillary study) III. Determine the influence of initial and changes in adiposity on changes in biomarkers from exercise. (Optional ancillary study) IV. Explore the effects of exercise training on a biomarker of accelerated aging in women cancer survivors. (Optional ancillary study)

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.

  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-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 milli international units per milliliter (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)
  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

Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Kerri Winters-Stone    503-494-0813    wintersk@ohsu.edu   
Principal Investigator: Kerri Winters-Stone         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Kerri Winters-Stone OHSU Knight Cancer Institute
  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: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01635413     History of Changes
Other Study ID Numbers: IRB00008560, NCI-2012-01141, MR00045870, CPC-12080-LX, IRB00008560, P30CA069533, R01CA163474
Study First Received: June 29, 2012
Last Updated: June 24, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 01, 2015