- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741335
GET FIT Prostate: A Randomized Controlled Exercise Trial
Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To determine and compare the efficacy of tai ji quan training and strength training in reducing the incidence of falls in prostate cancer survivors on antiandrogen therapy (ADT).
SECONDARY OBJECTIVE:
I. To determine and compare the efficacy of tai ji quan training and strength training to reduce frailty and dysfunction in prostate cancer survivors on ADT.
TERTIARY OBJECTIVE:
I. To determine how well the benefits of tai ji quan and strength interventions persist over a 6-month period.
EXPLORATORY OBJECTIVE:
I. To explore the patterns and predictors of types of men (including host and treatment factors) who benefit most from tai ji quan and strength training.
OUTLINE:
The study is a 3-group, single-blind, parallel design randomized controlled trial in prostate cancer survivors treated with ADT. Participants in each study group will attend supervised 1-hr classes, 3 days a week for 6 months.
ARM 1: Tai ji quan, an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements, specifically designed to challenge limits of stability and train gait patterns, as reflected in movements such as upright trunk positioning, displacement of body's center of mass over the weight-bearing leg, and step initiation, locomotion, and termination.
ARM 2: Strength training. Participants wear a weighted vest while performing exercises using functional movement patterns that challenge balance by using muscle groups and movement involved in everyday activities (chair rises, 90°squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups).
ARM 3: Stretching control. Participants in the control group will attend a supervised flexibility program of the same total weekly duration as the experimental arms (e.g., 3, 60-min sessions per week). Control participants will perform a series of whole body stretching exercises, according to the ACSM guidelines for flexibility training, with a focus on developing and maintaining a healthy back.
Six Month Follow-Up: Participants will be followed for an additional 6 months after the 6-month supervised intervention stops to track falls (using same monthly report used during intervention phase). Exercise questionnaires to track participation in home or community exercise programs and will be collected at the 9- and 12-month time periods.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with histologically confirmed prostate cancer (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his physician.)
- Currently on ADT for >= 6 months OR not currently receiving ADT, but received >= 6-month course within the last 10 years (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his physician.)
- If they have had other treatment, such as surgery, radiation or chemotherapy, it must have been completed >= 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his physician).
- Meets criteria for having experienced >= 1 fall in the last year (confirmed by self-report on Health History Questionnaire) or if no falls, meets criteria for slow Timed Up and Go (TUG) time (>= 12.0 seconds) OR slow chair stand time (>= 10.0 seconds) (confirmed by baseline screening testing).
Exclusion Criteria:
- Current participation in moderate or vigorous lower-body strength training two or more times per week for 30 minutes or more or participating in tai chi two or more times per week for 30 minutes or more (confirmed by self-report on Health History Questionnaire or by discretion of the principal investigator).
- 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/or 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.).
- Not medically cleared for participation in moderate intensity exercise. (Confirmed by physician clearance.).
- Knowingly unable to attend > 75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled. (Confirmed by documentation in the Case Report Form titled "CRF - Participant Contact Info_GET FIT Prostate").
- Not fluent in English and therefore incapable of answering survey questions, participating in class, following directions during performance testing, and providing informed consent when English is the language used. (Confirmed by documentation in the Case Report Form titled "CRF - Participant Contact Info_GET FIT Prostate" or the professional opinion of the principal investigator, Dr. Kerri Winters-Stone.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Strength Training
Participants wear a weighted vest while performing exercises using functional movement patterns used in everyday activities (chair rises, 90° squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups).
Participants attend supervised, group-based moderate-intensity strength training program remotely 3 times per week for 60 minutes per session.
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Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.
Other Names:
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Active Comparator: Stretching Control
Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back.
Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session.
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Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session
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Experimental: Tai Ji Quan Training
An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements.
Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session.
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Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of falls
Time Frame: Baseline up to 12 months
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Prospective assessment of falls will be done by collecting monthly 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.
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Baseline up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total frailty score
Time Frame: Baseline up to 12 months
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Frailty will be measured using the components of the Frailty Phenotype, which consist of measures of lean body mass, fatigue, physical activity, walk speed, and muscle strength, listed as additional outcomes below.
Each component of frailty will be assessed using measures that will capture frailty criteria in the prostate cancer survivor population and where cutoff scores can be appropriately determined.
A total frailty score will be calculated as: >= 3 components = frail; 1-2 components = prefrail; 0 components = robust.
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Baseline up to 12 months
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Lean body mass
Time Frame: Baseline up to 12 months
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Lean body mass will be measured by whole body by dual-energy X-ray absorptiometry (DXA) scan and by bioelectric impedance analysis.
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Baseline up to 12 months
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Fatigue-general
Time Frame: Baseline up to 12 months
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Fatigue will be measured using the Short Form (SF)-36 Vitality scale.
The scale ranges from 0-100 with lower scores indicating higher fatigue (i.e., less vitality).
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Baseline up to 12 months
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Fatigue-cancer
Time Frame: Baseline up to 12 months
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Fatigue will also be measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).
The questionnaire includes 13 items rated from "not at all" to "very much" over the past 7 days.
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Baseline up to 12 months
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Physical activity
Time Frame: Baseline up to 12 months
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Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report physical activity.
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Baseline up to 12 months
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Walk speed
Time Frame: Baseline up to 12 months
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Walk speed will be measured as the fastest time of two 15 foot walks at a usual pace.
Walks will be performed on an electronic gait mat to ensure accurate timing.
Cutpoints for the slowness component of frailty are: walk time >= 7 seconds for height >= 173 cm or time >= 6 seconds for height =< 173 cm. 3 meter Timed Up and Go will also be collected as a measure of slowness.
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Baseline up to 12 months
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Muscle strength
Time Frame: Baseline up to 12 months
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Muscle strength will be measured by timed chair stand test (seconds required to rise from chair 5 times).
The cutpoint for the frailty component of weakness is: chair stand time >= 12 seconds.
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Baseline up to 12 months
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Change in functional mobility
Time Frame: Baseline up to 12 months
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Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 meters (m), turn around a cone and return and sit in the chair.
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Baseline up to 12 months
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Change in functional balance
Time Frame: Baseline up to 12 months
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Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing.
Participants will perform a standard 30-second postural sway test to measure the velocity (meters per second [m/s]) of sway during quiet standing with i) feet together and eyes closed and ii) feet together and eyes open, using lightweight, inertial wireless sensors worn on the trunk.
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Baseline up to 12 months
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Change in perceived physical function
Time Frame: Baseline up to 12 months
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Perceived physical function will be measured by self-report using the physical function subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; version 3, App.
I).
Scores on the subscale range from 0-100 where higher scores indicate better physical functioning.
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Baseline up to 12 months
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Flexibility
Time Frame: Baseline up to 12 months
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Flexibility will be measured using the chair sit and reach.
While seated on the edge of a chair, participants bend from the hip and reach toward or past the toes.
The toes represent 0, so a reach short of the toes is recorded in negative inches, and a reach past the toes is recorded in positive inches.
Higher values indicate greater flexibility.
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Baseline up to 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kerri Winters-Stone, MD, OHSU Knight Cancer Institute
Publications and helpful links
General Publications
- Winters-Stone KM, Li F, Horak F, Dieckmann N, Hung A, Amling C, Beer TM. Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer. Trials. 2021 Nov 6;22(1):775. doi: 10.1186/s13063-021-05687-7.
- Winters-Stone KM, Boisvert C, Li F, Lyons KS, Beer TM, Mitri Z, Meyers G, Eckstrom E, Campbell KL. Delivering exercise medicine to cancer survivors: has COVID-19 shifted the landscape for how and who can be reached with supervised group exercise? Support Care Cancer. 2022 Mar;30(3):1903-1906. doi: 10.1007/s00520-021-06669-w. Epub 2021 Nov 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018354 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2019-01422 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA222605 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Access will be provided to investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.
Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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