Trial Outcomes & Findings for GET FIT Prostate: A Randomized Controlled Exercise Trial (NCT NCT03741335)
NCT ID: NCT03741335
Last Updated: 2025-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
284 participants
Primary outcome timeframe
Baseline up to 6 months
Results posted on
2025-07-02
Participant Flow
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.
284 men met eligibility criteria and were randomized to receive one of three treatment arms as specified per protocol.
Participant milestones
| Measure |
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.
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
97
|
92
|
95
|
|
Overall Study
COMPLETED
|
82
|
73
|
72
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GET FIT Prostate: A Randomized Controlled Exercise Trial
Baseline characteristics by cohort
| Measure |
Strength Training
n=97 Participants
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.
|
Stretching Control
n=92 Participants
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
|
Tai Ji Quan Training
n=95 Participants
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.
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
73.0 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
92 participants
n=7 Participants
|
95 participants
n=5 Participants
|
284 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 monthsProspective 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.
Outcome measures
| Measure |
Strength Training
n=94 Participants
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.
|
Stretching Control
n=84 Participants
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
|
Tai Ji Quan Training
n=85 Participants
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.
|
|---|---|---|---|
|
Number of Falls
|
0.29 Average fall count per 6 months
Interval 0.18 to 0.47
|
.33 Average fall count per 6 months
Interval 0.21 to 0.54
|
.38 Average fall count per 6 months
Interval 0.24 to 0.6
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsFrailty 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.
Outcome measures
| Measure |
Strength Training
n=84 Participants
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.
|
Stretching Control
n=77 Participants
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
|
Tai Ji Quan Training
n=80 Participants
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.
|
|---|---|---|---|
|
Change in Total Frailty Score
Baseline-6mo
|
.41 Incidence rate ratio
Interval 0.06 to 0.76
|
.84 Incidence rate ratio
Interval 0.56 to 1.2
|
.66 Incidence rate ratio
Interval 0.36 to 0.97
|
|
Change in Total Frailty Score
6mo-12mo
|
1.66 Incidence rate ratio
Interval 1.28 to 2.04
|
.99 Incidence rate ratio
Interval 0.69 to 1.31
|
1.16 Incidence rate ratio
Interval 0.83 to 1.49
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsLean body mass will be measured by bioelectric impedance analysis (in kg). Higher values indicate higher lean body mass.
Outcome measures
| Measure |
Strength Training
n=75 Participants
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.
|
Stretching Control
n=63 Participants
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
|
Tai Ji Quan Training
n=66 Participants
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.
|
|---|---|---|---|
|
Lean Body Mass
Baseline-6mo
|
-.03 Score on a scale per 6 months
Interval -0.72 to 0.66
|
-.68 Score on a scale per 6 months
Interval -1.42 to 0.07
|
-.87 Score on a scale per 6 months
Interval -1.64 to -0.1
|
|
Lean Body Mass
6mo-12mo
|
-.18 Score on a scale per 6 months
Interval -1.15 to 0.79
|
-.34 Score on a scale per 6 months
Interval -1.43 to 0.75
|
-.06 Score on a scale per 6 months
Interval -1.11 to 0.99
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsFatigue 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).
Outcome measures
| Measure |
Strength Training
n=97 Participants
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.
|
Stretching Control
n=91 Participants
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
|
Tai Ji Quan Training
n=94 Participants
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.
|
|---|---|---|---|
|
Fatigue-general
6mo-12mo
|
-1.26 Score on a scale per 6 months
Interval -2.56 to 0.04
|
-.08 Score on a scale per 6 months
Interval -1.47 to 1.32
|
.32 Score on a scale per 6 months
Interval -1.06 to 1.71
|
|
Fatigue-general
Baseline-6mo
|
1.60 Score on a scale per 6 months
Interval 0.08 to 3.12
|
-.63 Score on a scale per 6 months
Interval -2.21 to 0.95
|
1.47 Score on a scale per 6 months
Interval -0.14 to 3.08
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsFatigue 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.
Outcome measures
| Measure |
Strength Training
n=97 Participants
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.
|
Stretching Control
n=91 Participants
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
|
Tai Ji Quan Training
n=94 Participants
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.
|
|---|---|---|---|
|
Fatigue-cancer
Baseline-6mo
|
1.79 Score on a scale per 6 months
Interval 0.54 to 3.05
|
.51 Score on a scale per 6 months
Interval -0.79 to 1.81
|
1.74 Score on a scale per 6 months
Interval 0.42 to 3.07
|
|
Fatigue-cancer
6mo-12mo
|
-1.15 Score on a scale per 6 months
Interval -2.51 to 0.2
|
-.32 Score on a scale per 6 months
Interval -1.76 to 1.12
|
.17 Score on a scale per 6 months
Interval -1.28 to 1.61
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPhysical 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.
Outcome measures
| Measure |
Strength Training
n=97 Participants
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.
|
Stretching Control
n=91 Participants
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
|
Tai Ji Quan Training
n=94 Participants
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.
|
|---|---|---|---|
|
Physical Activity
Baseline-6mo
|
514.72 Score on a scale per 6 months
Interval -26.22 to 1055.67
|
-702.11 Score on a scale per 6 months
Interval -1261.49 to -142.74
|
-319.98 Score on a scale per 6 months
Interval -885.25 to 245.3
|
|
Physical Activity
6mo-12mo
|
-710.9 Score on a scale per 6 months
Interval -1226.03 to -195.76
|
259.06 Score on a scale per 6 months
Interval -285.54 to 803.67
|
196.81 Score on a scale per 6 months
Interval -354.3 to 747.93
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsWalk 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.
Outcome measures
| Measure |
Strength Training
n=84 Participants
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.
|
Stretching Control
n=78 Participants
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
|
Tai Ji Quan Training
n=81 Participants
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.
|
|---|---|---|---|
|
Walk Speed
Baseline-6mo
|
.11 Score on a scale per 6 months
Interval 0.08 to 0.15
|
.07 Score on a scale per 6 months
Interval 0.04 to 0.11
|
.09 Score on a scale per 6 months
Interval 0.06 to 0.13
|
|
Walk Speed
6mo-12mo
|
-.03 Score on a scale per 6 months
Interval -0.06 to 0.0
|
-.02 Score on a scale per 6 months
Interval -0.06 to 0.01
|
-.02 Score on a scale per 6 months
Interval -0.05 to 0.01
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsMuscle 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.
Outcome measures
| Measure |
Strength Training
n=84 Participants
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.
|
Stretching Control
n=77 Participants
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
|
Tai Ji Quan Training
n=80 Participants
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.
|
|---|---|---|---|
|
Muscle Strength
Baseline-6mo
|
-2.63 Score on a scale per 6 months
Interval -3.45 to -1.81
|
-2.15 Score on a scale per 6 months
Interval -3.0 to -1.28
|
-1.85 Score on a scale per 6 months
Interval -2.73 to -0.96
|
|
Muscle Strength
6mo-12mo
|
.76 Score on a scale per 6 months
Interval -0.07 to 1.6
|
0.18 Score on a scale per 6 months
Interval -0.72 to 1.08
|
.75 Score on a scale per 6 months
Interval -0.14 to 1.64
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsFunctional 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.
Outcome measures
| Measure |
Strength Training
n=84 Participants
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.
|
Stretching Control
n=78 Participants
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
|
Tai Ji Quan Training
n=80 Participants
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.
|
|---|---|---|---|
|
Change in Functional Mobility
Baseline-6mo
|
-1.45 Score on a scale per 6 months
Interval -1.9 to -1.0
|
-.61 Score on a scale per 6 months
Interval -1.08 to -0.15
|
-.93 Score on a scale per 6 months
Interval -1.4 to -0.45
|
|
Change in Functional Mobility
6mo-12mo
|
.60 Score on a scale per 6 months
Interval 0.2 to 1.0
|
.14 Score on a scale per 6 months
Interval -0.28 to 0.56
|
.17 Score on a scale per 6 months
Interval -0.24 to 0.59
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsFunctional 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.
Outcome measures
| Measure |
Strength Training
n=84 Participants
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.
|
Stretching Control
n=78 Participants
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
|
Tai Ji Quan Training
n=81 Participants
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.
|
|---|---|---|---|
|
Change in Functional Balance
Baseline-6mo
|
0.00 Score on a scale per 6 months
Interval -0.04 to 0.04
|
.01 Score on a scale per 6 months
Interval -0.04 to 0.05
|
-.02 Score on a scale per 6 months
Interval -0.06 to 0.03
|
|
Change in Functional Balance
6mo-12mo
|
-.02 Score on a scale per 6 months
Interval -0.03 to 0.06
|
.01 Score on a scale per 6 months
Interval -0.03 to 0.06
|
.02 Score on a scale per 6 months
Interval -0.02 to 0.07
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPerceived 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.
Outcome measures
| Measure |
Strength Training
n=97 Participants
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.
|
Stretching Control
n=91 Participants
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
|
Tai Ji Quan Training
n=92 Participants
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.
|
|---|---|---|---|
|
Change in Perceived Physical Function
Baseline-6mo
|
-1.02 Score on a scale per 6 months
Interval -3.5 to 1.45
|
-.35 Score on a scale per 6 months
Interval -2.93 to 2.22
|
-2.18 Score on a scale per 6 months
Interval -4.82 to 0.46
|
|
Change in Perceived Physical Function
6mo-12mo
|
-1.27 Score on a scale per 6 months
Interval -3.95 to 1.41
|
-.32 Score on a scale per 6 months
Interval -3.16 to 2.53
|
1.85 Score on a scale per 6 months
Interval -1.01 to 4.71
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsFlexibility 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.
Outcome measures
| Measure |
Strength Training
n=85 Participants
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.
|
Stretching Control
n=80 Participants
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
|
Tai Ji Quan Training
n=84 Participants
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.
|
|---|---|---|---|
|
Flexibility
Baseline-6mo
|
1.70 Score on a scale per 6 months
Interval 0.69 to 2.7
|
1.93 Score on a scale per 6 months
Interval 0.87 to 2.99
|
1.73 Score on a scale per 6 months
Interval 0.65 to 2.81
|
|
Flexibility
6mo-12mo
|
-1.11 Score on a scale per 6 months
Interval -1.88 to -0.33
|
-1.96 Score on a scale per 6 months
Interval -2.79 to -1.12
|
-1.59 Score on a scale per 6 months
Interval -2.4 to -0.77
|
Adverse Events
Strength Training
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Stretching Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Tai Ji Quan Training
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Strength Training
n=97 participants at risk
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.
|
Stretching Control
n=92 participants at risk
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
|
Tai Ji Quan Training
n=95 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/97 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/92 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
1.1%
1/95 • Number of events 1 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
1.0%
1/97 • Number of events 1 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/92 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/95 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/97 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/92 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
1.1%
1/95 • Number of events 1 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
|
General disorders
New immunotherapy treatment
|
0.00%
0/97 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
0.00%
0/92 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
1.1%
1/95 • Number of events 1 • Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kerri Winters-Stone
Oregon Health & Science University
Phone: 503-494-0813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place