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Completed

NCT Number: NCT01635413

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

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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Key information

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise Intervention

Behavioral

Undergo strength training classes

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Falls

    Time frame: Baseline up to 12 months

    Prospective assessment of falls will be done by collecting monthly and quarterly reports returned by postal and/or electronic mail. 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.

Secondary outcomes

  1. Muscle strength

    Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment

    Measured by 1-repetition maximum (1-RM) for leg press. The maximum amount of weight that can be lifted one time.

  2. Postural stability

    Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment

    Measured by Computerized dynamic posturography using the sensory organization test (SOT) and limits of stability (LOS). The SOT generates an equilibrium scores and sensory ratios that range from 0-100, where 100 = perfect stability and 0 = an inability to maintain balance and a fall. The LOS measures the average % of targeted distances reached (end point excursion) and average % of movement in the targeted direction (directional control).

  3. Flexibility

    Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study

    Measured by the standardized chair sit-and-reach test for lower body flexibility. Designed for older adults with demonstrated validity and reliability in older adults (test-retest 0.95-0.96).

  4. Physical Function

    Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study

    Measured by the Physical Performance Battery (PPB). The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.

  5. Injurious falls

    Time frame: Baseline up to 12 months

    Collected during prospective monthly and quarterly reports of falls. A fall is considered ''injurious'' if it results in fractures, head injuries, sprains, bruises, scrapes, or serious joint injuries, or if the participant seeks medical care.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: GET FIT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2012
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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