Clinical trial NCT03741335: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2018-11-14
Enrollment: 335
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-group, single-blind, parallel design randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.).

Primary outcomes:
measure: Change in number of falls
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change in total frailty score
timeFrame: Baseline up to 12 months
measure: Lean body mass
timeFrame: Baseline up to 12 months
measure: Fatigue-general
timeFrame: Baseline up to 12 months
measure: Fatigue-cancer
timeFrame: Baseline up to 12 months
measure: Physical activity
timeFrame: Baseline up to 12 months
measure: Walk speed
timeFrame: Baseline up to 12 months
measure: Muscle strength
timeFrame: Baseline up to 12 months
measure: Change in functional mobility
timeFrame: Baseline up to 12 months
measure: Change in functional balance
timeFrame: Baseline up to 12 months
measure: Change in perceived physical function
timeFrame: Baseline up to 12 months
measure: Flexibility
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.