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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Neoplasm Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm I (strength training)

Patients attend strength training classes for 1 hour 2 days per week.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Undergo strength training classes

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (tai chi)

Patients attend tai chi classes for 1 hour 2 days per week.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Undergo tai chi classes

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm III (control)

Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type BEHAVIORAL

Undergo stretching and relaxation classes

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Exercise Intervention

Undergo strength training classes

Intervention Type BEHAVIORAL

Exercise Intervention

Undergo tai chi classes

Intervention Type BEHAVIORAL

Exercise Intervention

Undergo stretching and relaxation classes

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Kerri Winters

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerri Winters-Stone

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Sitemba J, Crisafio M, Li F, Eckstrom E, Winters-Stone KM. Evaluating recruitment, retention, and adherence patterns in the GET FIT fall prevention exercise trial in older, postmenopausal cancer survivors. Support Care Cancer. 2025 Jul 28;33(8):727. doi: 10.1007/s00520-025-09767-1.

Reference Type DERIVED

PMID: 40721864 (View on PubMed)

Winters-Stone KM, Stoyles SA, Dieckmann NF, Eckstrom E, Luoh SW, Horak FB, Roeland EJ, Li F. Can strength training or tai ji quan training reduce frailty in postmenopausal women treated with chemotherapy? A secondary data analysis of the GET FIT trial. J Cancer Surviv. 2024 Aug;18(4):1179-1189. doi: 10.1007/s11764-024-01592-5. Epub 2024 Apr 20.

Reference Type DERIVED

PMID: 38642204 (View on PubMed)

Winters-Stone KM, Roeland EJ, Li F, Eckstrom E, Horak F, Dieckmann NF, Stoyles SA, Luoh SW. Reply to Y.-T. Hu et al. J Clin Oncol. 2023 Sep 10;41(26):4316-4317. doi: 10.1200/JCO.23.01034. Epub 2023 Jun 28. No abstract available.

Reference Type DERIVED

PMID: 37379504 (View on PubMed)

Winters-Stone KM, Horak F, Dieckmann NF, Luoh SW, Eckstrom E, Stoyles SA, Roeland EJ, Li F. GET FIT: A Randomized Clinical Trial of Tai Ji Quan Versus Strength Training for Fall Prevention After Chemotherapy in Older, Postmenopausal Women Cancer Survivors. J Clin Oncol. 2023 Jun 20;41(18):3384-3396. doi: 10.1200/JCO.22.01519. Epub 2023 Mar 8.

Reference Type DERIVED

PMID: 36888933 (View on PubMed)

McGinnis GJ, Holden S, Yu B, Ransom C, Guidarelli C, De B, Diao K, Boyce D, Thomas CR Jr, Winters-Stone K, Raber J. Association of fall rate and functional status by APOE genotype in cancer survivors after exercise intervention. Oncotarget. 2022 Nov 17;13:1259-1270. doi: 10.18632/oncotarget.28310.

Reference Type DERIVED

PMID: 36441715 (View on PubMed)

Winters-Stone KM, Li F, Horak F, Luoh SW, Bennett JA, Nail L, Dieckmann N. Comparison of tai chi vs. strength training for fall prevention among female cancer survivors: study protocol for the GET FIT trial. BMC Cancer. 2012 Dec 5;12:577. doi: 10.1186/1471-2407-12-577.

Reference Type DERIVED

PMID: 23217054 (View on PubMed)