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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kerri Winters, OHSU Knight Cancer Institute

Brief Summary:
The GET FIT Prostate trial (Group Exercise Training for Fall prevention and functional Improvements during and after Treatment for Prostate cancer) is a single-blind, parallel group, randomized controlled trial comparing - 1) tai ji quan (functional balance) and 2) strength training (functional strength) against each other and vs. 3) a stretching control (functional mobility) - over a 6-mos. supervised intervention and 6-mos. follow-up. Two million prostate cancer survivors are alive in the U.S. and nearly half (45%) will receive androgen deprivation therapy (ADT) to reduce tumor androgen exposure and slow down cancer progression. While beneficial for cancer survival, significant treatment-induced side effects from ADT may lead to serious health consequences including falls, frailty, and dysfunction that contribute to morbidity and mortality.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Tai Ji Quan training Behavioral: Strength training Behavioral: Stretching Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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 OBJECTIVES:

I. To determine how well the benefits of tai ji quan and strength interventions persist over a 6-month period.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Stretching
Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with histologically confirmed prostate cancer.
  • Currently on ADT for >= 6 months OR not currently receiving ADT, but received >= 6-month course within the last 10 years.
  • Completed any surgery, radiation or chemotherapy ≥ 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer
  • 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 TUG time (≥12.0 seconds) OR slow chair stand time (≥10.0 seconds).

Exclusion Criteria:

  • Current participation in moderate-vigorous intensity 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.
  • Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent.
  • A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise.
  • Not medically cleared for participation in moderate intensity exercise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741335


Contacts
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Contact: Carolyn Guidarelli 503-346-0307 borsch@ohsu.edu

Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Loy    503-346-0444    exercise@ohsu.edu   
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kerri Winters-Stone, MD OHSU Knight Cancer Institute

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Responsible Party: Kerri Winters, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03741335     History of Changes
Other Study ID Numbers: STUDY00018354
R01CA222605 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases