Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-02 @ 6:31 AM
Study NCT ID:
NCT03741335
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GET FIT Prostate: A Randomized Controlled Exercise Trial
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-01422 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00018354 | OTHER | OHSU Knight Cancer Institute | View | |
| R01CA222605 | NIH | None | https://reporter.nih.gov/quic… | View |