Back to resultsGET FIT Prostate: A Randomized Controlled Exercise Trial
Primary Purpose
Prostate Carcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Stretching
Tai Chi
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Carcinoma
Eligibility Criteria
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.).
Sites / Locations
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Strength Training
Stretching Control
Tai Ji Quan Training
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in number of falls
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
Change in total frailty score
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
Lean body mass will be measured by whole body by dual-energy X-ray absorptiometry (DXA) scan and by bioelectric impedance analysis.
Fatigue-general
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).
Fatigue-cancer
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.
Physical activity
Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report physical activity.
Walk speed
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.
Muscle strength
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.
Change in functional mobility
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.
Change in functional balance
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.
Change in perceived physical function
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
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.
Full Information
NCT ID
NCT03741335
First Posted
October 30, 2018
Last Updated
July 9, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT03741335
Brief Title
GET FIT Prostate: A Randomized Controlled Exercise Trial
Official Title
Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3-group, single-blind, parallel design randomized controlled trial
Masking
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.
Allocation
Randomized
Enrollment
335 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strength Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tai Ji Quan Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Strength Training
Intervention Description
Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of falls
Description
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.
Time Frame
Baseline up to 12 months
Secondary Outcome Measure Information:
Title
Change in total frailty score
Description
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.
Time Frame
Baseline up to 12 months
Title
Lean body mass
Description
Lean body mass will be measured by whole body by dual-energy X-ray absorptiometry (DXA) scan and by bioelectric impedance analysis.
Time Frame
Baseline up to 12 months
Title
Fatigue-general
Description
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).
Time Frame
Baseline up to 12 months
Title
Fatigue-cancer
Description
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.
Time Frame
Baseline up to 12 months
Title
Physical activity
Description
Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report physical activity.
Time Frame
Baseline up to 12 months
Title
Walk speed
Description
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.
Time Frame
Baseline up to 12 months
Title
Muscle strength
Description
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.
Time Frame
Baseline up to 12 months
Title
Change in functional mobility
Description
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.
Time Frame
Baseline up to 12 months
Title
Change in functional balance
Description
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.
Time Frame
Baseline up to 12 months
Title
Change in perceived physical function
Description
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.
Time Frame
Baseline up to 12 months
Title
Flexibility
Description
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.
Time Frame
Baseline up to 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34742325
Citation
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.
Results Reference
derived
PubMed Identifier
34741653
Citation
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.
Results Reference
derived
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GET FIT Prostate: A Randomized Controlled Exercise Trial
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