Prostate CarcinomaNCT03741335
GET FIT Prostate: A Randomized Controlled Exercise Trial
A study testing Resistance Training, Stretching and Tai Chi in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Resistance Training, Stretching and Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer
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
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- To determine how well the benefits of tai ji quan and strength interventions persist over a 6-month period.
EXPLORATORY OBJECTIVE:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Resistance Training, Stretching, Tai Chi
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Also called Strength Training
Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.
StretchingOther
Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session
Tai ChiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strength Training | Experimental | 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. Receives: Other: Resistance Training |
| Stretching Control | Active comparator | 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. Receives: Other: Stretching |
| Tai Ji Quan Training | Experimental | 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. Receives: Other: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 6 months
Secondary outcomes (11)
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 is assessed using measures that will capture frailty criteria in the prostate cancer survivor population using appropriate cutoff scores indicating that a component meets a particular criterion. A total frailty score was calculated for each patient at each timepoint defined as a count of the number of frailty components met.
Measured: Baseline up to 12 months
Lean Body Mass
Lean body mass will be measured by bioelectric impedance analysis (in kg). Higher values indicate higher lean body mass.
Measured: Baseline up to 12 months
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).
Measured: Baseline up to 12 months
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, and possible scores from 0 to 52. Lower scores indicate more fatigue, while higher scores indicate less severe fatigue.
Measured: Baseline up to 12 months
Physical Activity
Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report moderate-to-vigorous physical activity (MVPA). Lower scores indicate less MVPA and higher scores indicate more MVPA.
Measured: Baseline up to 12 months
Walk Speed
Walk speed will be measured by the 3-meter Timed Up and Go, a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair.
Measured: Baseline up to 12 months
Muscle Strength
Muscle strength will be measured by timed chair stand test (seconds required to rise from chair 5 times). The larger the time, the longer it took them to complete 5 chair stands.
Measured: Baseline up to 12 months
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. Larger times means they were slower, and shorter times mean they were faster.
Measured: Baseline up to 12 months
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 feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk. Lower sway velocity (m/s) indicates better postural stability.
Measured: Baseline up to 12 months
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.
Measured: Baseline up to 12 months
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 negative values indicate greater flexibility.
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start5 Feb 2019
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-group, single-blind, parallel design randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741335
- Sponsor's protocol ID
- STUDY00018354
- Other IDs
- NCI-2019-01422, STUDY00018354, R01CA222605
- Status last verified
- Jun 2025
- First submitted
- 30 Oct 2018
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual quantitative participant data collected during the trial, after deidentification.
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939Winters-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.
PubMed 34742325Winters-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.
PubMed 34741653
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer
- ClinicalTrials.gov ID
- NCT03741335
- Acronym / sponsor ID
- STUDY00018354
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Posted 2 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- To determine how well the benefits of tai ji quan and strength interventions persist over a 6-month period.
EXPLORATORY OBJECTIVE:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-group, single-blind, parallel design randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Strength Training | Experimental | Other: Resistance TrainingParticipants 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. |
| Stretching Control | Active comparator | Other: StretchingParticipants 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. |
| Tai Ji Quan Training | Experimental | Other: Tai ChiAn 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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").
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingAlso: Strength TrainingParticipants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session. | Other | Strength Training |
| StretchingParticipants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session | Other | Stretching Control |
| Tai ChiParticipants 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. | Other | Tai Ji Quan Training |
Primary outcome
Number of Falls
Time frame: Baseline up to 6 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.
11 secondary outcomes
Change in Total Frailty Score
Time frame: Baseline up to 12 months
Lean Body Mass
Time frame: Baseline up to 12 months
Fatigue-general
Time frame: Baseline up to 12 months
Fatigue-cancer
Time frame: Baseline up to 12 months
Physical Activity
Time frame: Baseline up to 12 months
Walk Speed
Time frame: Baseline up to 12 months
Muscle Strength
Time frame: Baseline up to 12 months
Change in Functional Mobility
Time frame: Baseline up to 12 months
Change in Functional Balance
Time frame: Baseline up to 12 months
Change in Perceived Physical Function
Time frame: Baseline up to 12 months
Flexibility
Time frame: Baseline up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Derived from this study: PubMed 34742325Winters-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.
- Derived from this study: PubMed 34741653Winters-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.
- Individual participant dataSharing planned: Yes. All individual quantitative participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Winters-Stone, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training, Stretching and Tai Chi in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Falls (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741335, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.