N/A
N=284
GET FIT Prostate: A Randomized Controlled Exercise Trial
Prostate Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03741335 ↗Enrolled (actual)
284
Serious AEs
1.4%
Results posted
Jul 2025
Primary outcome: Primary: Number of Falls — 0.29; .33; .38 Average fall count per 6 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resistance Training (Other); Stretching (Other); Tai Chi (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Falls |
0.29; .33; .38 | — |
| SECONDARY Change in Total Frailty Score |
.41; .84; .66; 1.66; .99; 1.16 | — |
| SECONDARY Lean Body Mass |
-.03; -.68; -.87; -.18; -.34; -.06 | — |
| SECONDARY Fatigue-general |
1.60; -.63; 1.47; -1.26; -.08; .32 | — |
| SECONDARY Fatigue-cancer |
1.79; .51; 1.74; -1.15; -.32; .17 | — |
| SECONDARY Physical Activity |
514.72; -702.11; -319.98; -710.9; 259.06; 196.81 | — |
| SECONDARY Walk Speed |
.11; .07; .09; -.03; -.02; -.02 | — |
| SECONDARY Muscle Strength |
-2.63; -2.15; -1.85; .76; 0.18; .75 | — |
| SECONDARY Change in Functional Mobility |
-1.45; -.61; -.93; .60; .14; .17 | — |
| SECONDARY Change in Functional Balance |
0.00; .01; -.02; -.02; .01; .02 | — |
| SECONDARY Change in Perceived Physical Function |
-1.02; -.35; -2.18; -1.27; -.32; 1.85 | — |
| SECONDARY Flexibility |
1.70; 1.93; 1.73; -1.11; -1.96; -1.59 | — |
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
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.).
Data sourced from ClinicalTrials.gov (NCT03741335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.