GET FIT Prostate: A Randomized Controlled Exercise Trial

Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03741335

Enrollment

284

Registered

2018-11-14

Start date

2019-02-05

Completion date

2024-06-30

Last updated

2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

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.

Interventions

OTHERResistance Training

Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.

OTHERStretching

Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session

OTHERTai Chi

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (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.

Intervention model description

3-group, single-blind, parallel design randomized controlled trial

Eligibility

Sex/Gender

MALE

Age

18 Years to 100 Years

Healthy volunteers

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.).

Design outcomes

Primary

Measure	Time frame	Description
Number of Falls	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.

Secondary

Measure	Time frame	Description
Lean Body Mass	Baseline up to 12 months	Lean body mass will be measured by bioelectric impedance analysis (in kg). Higher values indicate higher lean body mass.
Fatigue-general	Baseline up to 12 months	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	Baseline up to 12 months	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.
Physical Activity	Baseline up to 12 months	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.
Walk Speed	Baseline up to 12 months	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.
Change in Total Frailty Score	Baseline up to 12 months	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.
Change in Functional Mobility	Baseline up to 12 months	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.
Change in Functional Balance	Baseline up to 12 months	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.
Change in Perceived Physical Function	Baseline up to 12 months	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	Baseline up to 12 months	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.
Muscle Strength	Baseline up to 12 months	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.

Countries

United States

Participant flow

Recruitment details

Community-dwelling prostate cancer survivors were recruited between February 2019 and September 2022. The first participant was enrolled on the 5th of February 2019 and the last participant was enrolled on the 19th of September 2022.

Pre-assignment details

284 men met eligibility criteria and were randomized to receive one of three treatment arms as specified per protocol.

Participants by arm

Arm	Count
Strength Training 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. Resistance Training: Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.	97
Stretching Control 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. Stretching: Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session	92
Tai Ji Quan Training 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. Tai Chi: 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.	95
Total	284

Baseline characteristics

Characteristic	Strength Training	Total	Tai Ji Quan Training	Stretching Control
Age, Continuous	72.7 years STANDARD_DEVIATION 6.7	72.7 years STANDARD_DEVIATION 7.1	73.0 years STANDARD_DEVIATION 7.1	72.4 years STANDARD_DEVIATION 7.4
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	6 Participants	3 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	95 Participants	269 Participants	90 Participants	84 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	9 Participants	2 Participants	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	7 Participants	3 Participants	3 Participants
Race (NIH/OMB) More than one race	2 Participants	7 Participants	3 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	8 Participants	2 Participants	3 Participants
Race (NIH/OMB) White	90 Participants	259 Participants	85 Participants	84 Participants
Region of Enrollment United States	97 participants	284 participants	95 participants	92 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	97 Participants	284 Participants	95 Participants	92 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	2 / 97	4 / 92	1 / 95
other Total, other adverse events	0 / 97	0 / 92	0 / 95
serious Total, serious adverse events	1 / 97	0 / 92	3 / 95

Outcome results

Primary

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.

Time frame: Baseline up to 6 months

Arm	Measure	Value (MEAN)
Strength Training	Number of Falls	0.29 Average fall count per 6 months
Stretching Control	Number of Falls	.33 Average fall count per 6 months
Tai Ji Quan Training	Number of Falls	.38 Average fall count per 6 months

Secondary

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.