GET FIT Prostate: A Randomized Controlled Exercise Trial
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|ClinicalTrials.gov Identifier: NCT03741335|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Tai Ji Quan training Behavioral: Strength training Behavioral: Stretching||Not Applicable|
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 androgen deprivation therapy (ADT).
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.
I. To determine how well the benefits of tai ji quan and strength interventions persist over a 6-month period.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||3-group, single-blind, parallel design randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessors will be masked to the participants assigned study arm. Participants will not be formally masked from knowing whether or not they are assigned to an experimental or control group, but every effort will be made not to overemphasize expected outcomes.|
|Primary Purpose:||Supportive Care|
|Official Title:||Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer|
|Actual Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Experimental: Tai Ji Quan Training
An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements.
Behavioral: Tai Ji Quan training
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
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).
Behavioral: Strength training
Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.
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 3 times per week for 60 minutes per session.
- Change in number of falls [ Time Frame: Baseline up to 12 months ]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.
- Frailty: Change in total frailty score [ Time Frame: Baseline up to 12 months ]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.
- Lean body mass [ Time Frame: Baseline up to 12 months ]Lean body mass will be measured by whole body by DXA scan and by bioelectric impedance analysis.
- Fatigue-General [ Time Frame: Baseline up to 12 months ]Fatigue will be measured using the SF-36 Vitality Scale. The scale ranges from 0-100 with lower scores indicating higher fatigue (i.e., less vitality).
- Fatigue-Cancer [ Time Frame: Baseline up to 12 months ]Fatigue will also be measured using the FACIT-F. The questionnaire includes 13 items rated from "not at all to "very much" over the past 7 days. Possible scores range from 0 to 52. Low values indicate no fatigue, while high values indicate high fatigue.
- Physical activity [ Time Frame: Baseline up to 12 months ]Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report physical activity.
- Walk speed [ Time Frame: Baseline up to 12 months ]Walk speed will be measured as the fastest time of two 15' 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.
- Muscle strength [ Time Frame: Baseline up to 12 months ]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.
- Physical Function: Change in Functional mobility [ Time Frame: Baseline up to 12 months ]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 m, turn around a cone and return and sit in the chair. This will also be completed with a secondary task, where the participant counts backwards by 3 starting at 99.
- Physical Function: Change in Functional balance [ Time Frame: Baseline up to 12 months ]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 (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.
- Physical Function: Change in perceived physical function [ Time Frame: Baseline up to 12 months ]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
- Flexibility [ Time Frame: Baseline up to 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741335
|Contact: Carolyn Guidarellifirstname.lastname@example.org|
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Loy 503-346-0444 email@example.com|
|Principal Investigator:||Kerri Winters-Stone, MD||OHSU Knight Cancer Institute|