Trial Outcomes & Findings for Improving Health for Older Adults With Pain Through Engagement (Open-pilot) (NCT NCT05782231)
NCT ID: NCT05782231
Last Updated: 2025-05-15
Results Overview
\>=75 of patients approached agree to participate in intervention
COMPLETED
NA
33 participants
10 weeks
2025-05-15
Participant Flow
Recruitment was facilitated through posted Massachusetts General Hospital (MGH) Institutional Review Board-approved flyers in the clinic and the hospital's research recruitment site, and referrals from MGH Revere HealthCare Center physicians, nurses, psychologists, and other relevant staff.
All enrolled participants were assigned to the intervention, GetActive+.
Participant milestones
| Measure |
GetActive+
10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Overall Study
STARTED
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33
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|
Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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1
|
Reasons for withdrawal
| Measure |
GetActive+
10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Improving Health for Older Adults With Pain Through Engagement (Open-pilot)
Baseline characteristics by cohort
| Measure |
GetActive+
n=33 Participants
10-week group mind body program focused on improving self-report, performance-based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota-based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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21 Participants
n=5 Participants
|
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Age, Continuous
|
67.76 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
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Sex: Female, Male
Female
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28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeks\>=75 of patients approached agree to participate in intervention
Outcome measures
| Measure |
Experimental: GetActive+
n=38 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Feasibility of Intervention Completion
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33 Participants
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PRIMARY outcome
Timeframe: 10 weeks\>=75% of enrolled participants complete at least 8/10 sessions
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Acceptability
|
31 Participants
|
PRIMARY outcome
Timeframe: Fidelity, as described above, was assessed periodically throughout the 11 months of the study, and is presented here as the sum total counts of all the high scoring components (again, described above) that were assessed over this 11 month time period.Clinician raters, with experience in intervention refinement or delivery, randomly selected 20% of all sessions to rate their components for this outcome. All sessions were audio-recorded. The overall number of units analyzed, which is reported below, refers to that 20% of the total number of sessions that were then analyzed for this outcome); the overall number of participants analyzed, which is also reported below, is the total number of participants in this study. Clinician raters used fidelity checklists to guide their ratings of the different session components. A session component was considered delivered as intended if the rater provided a score ≥8 (the scale was 1=poor to 10=outstanding). Reported here are the number of session components with a score ≥8, indicating successful delivery; the percentage of the total analyzed sessions that this represents is also calculated out below. The study benchmark we looked to meet for this fidelity measure was 75%.
Outcome measures
| Measure |
Experimental: GetActive+
n=1170 Number of session components
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Fidelity of Session Components, As Rated by Clinicians
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1145 Number of session components
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)6-minute walk test (6MWT), assesses distance walked (in meters) in 6 minutes.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Physical Function - Performance-based
Baseline
|
243.1 meters
Standard Deviation 82.6
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Physical Function - Performance-based
Post-test
|
277.0 meters
Standard Deviation 77.8
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)Average step count with ActiGraph GT3X-BTLE
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Physical Function - Objective
Baseline
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2561.4 steps
Standard Deviation 2013.4
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Physical Function - Objective
Post-test
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2560.3 steps
Standard Deviation 1797.7
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Short Form Brief Pain Inventory (BPI) pain severity subscale assesses pain at its worst, least, average, and current. Minimum = 0, maximum = 10. Higher scores indicate worse outcome. The interference subscale assesses pain interference in the last 24 hours. Minimum = 0, maximum = 10. Higher scores indicate worse interference.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales
Baseline
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5.7 units on a scale
Standard Deviation 1.8
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Short Form Brief Pain Inventory (BPI) Pain Severity and Interference Subscales
Post-test
|
4.4 units on a scale
Standard Deviation 2.3
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Patient Health Questionnaire (PHQ-8) is an assessment of depressive symptoms. Total summary score with Minimum = 0, Maximum = 24. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Patient Health Questionnaire-8 (PHQ-8)
Baseline
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8.4 units on a scale
Standard Deviation 6.0
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Patient Health Questionnaire-8 (PHQ-8)
Post-test
|
5.7 units on a scale
Standard Deviation 6.1
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Generalized Anxiety Disorder scale-7 (GAD-7) is an assessment of generalized anxiety symptoms. GAD-7 total score is obtained by adding the score for each of the items. Minimum = 0, Maximum = 21. Scores of 5-9 (mild), 10-14 (moderate), and 15-21 (severe) represent thresholds for mild, moderate, and severe anxiety. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Generalized Anxiety Disorder Scale-7 (GAD-7);
Post-test
|
5.1 units on a scale
Standard Deviation 4.2
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Generalized Anxiety Disorder Scale-7 (GAD-7);
Baseline
|
6.2 units on a scale
Standard Deviation 5.4
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b assesses one's ability to engage in physical activities. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the average (mean) physical function T score in the reference general population, with a standard deviation of 10. Higher T scores reflect greater physical function and ability to carry out physical activities.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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PROMIS Physical Function - Short Form 6b v2.0
Baseline
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38.7 T score
Standard Deviation 7.3
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PROMIS Physical Function - Short Form 6b v2.0
Post-test
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43.2 T score
Standard Deviation 8.7
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Interpersonal Support Evaluation List (ISEL-12) measures perceptions of social support. Minimum = 12, Maximum = 48. Higher scores indicate a better outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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The Interpersonal Support Evaluation List (ISEL-12),
Baseline
|
35.4 units on a scale
Standard Deviation 7.8
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The Interpersonal Support Evaluation List (ISEL-12),
Post-test
|
36.5 units on a scale
Standard Deviation 7.1
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Pain Catastrophizing Scale (PCS) is a 13-item measure that assesses hopelessness, helplessness and rumination about pain. Subscales (rumination, magnification, and helplessness) are calculated by summing item responses for the associated questions, and then combined (summed) to create the total score. Items range from 0-4, and total scores range from 0-52. For the subscales, rumination ranges from 0-16, magnification ranges from 0-12, and helplessness ranges from 0-24. Higher scores (on subscales and the scale as a whole) indicate higher levels of pain catastrophizing, i.e. higher scores indicate poorer outcomes. Both subscales and total score are shown here. The means reported reflect the mean of each subscale or total score among GetActive+ participants at the indicated timepoint.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Pain Catastrophizing Scale (PCS)
Total Score - Baseline
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20.6 score on a scale
Standard Deviation 14.5
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Pain Catastrophizing Scale (PCS)
Total score - Post-test
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15.5 score on a scale
Standard Deviation 11.4
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Pain Catastrophizing Scale (PCS)
Rumination- Baseline
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7.3 score on a scale
Standard Deviation 5.0
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Pain Catastrophizing Scale (PCS)
Rumination- Post-test
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5.7 score on a scale
Standard Deviation 4.1
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Pain Catastrophizing Scale (PCS)
Magnification - Baseline
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4.2 score on a scale
Standard Deviation 3.8
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Pain Catastrophizing Scale (PCS)
Magnification - Post-test
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3.3 score on a scale
Standard Deviation 2.7
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Pain Catastrophizing Scale (PCS)
Helplessness - Baseline
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9.1 score on a scale
Standard Deviation 6.7
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Pain Catastrophizing Scale (PCS)
Helplessness - Post-test
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6.6 score on a scale
Standard Deviation 5.4
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Pain, Enjoyment of Life and General Activity scale (PEG) rates a participant's pain intensity and related interference in enjoyment of life and general activity. Items are scored on a scale of 0-10, with 0 being no pain (or interference) and 10 being pain as bad as you can imagine (or complete interference). The total score is a sum of the three individual items (Pain Intensity Average, Activity Interference, Enjoyment Interference) divided by 3, with a minimum possible score of 0 and a maximum possible score of 10. Higher scores indicate worse outcomes (i.e. more pain intensity and interference). Scores presented here are the mean total score and mean item scores at the indicated timepoints.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Total Score (Baseline)
|
6.0 score on a scale
Standard Deviation 2.2
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Total Score (Posttest)
|
4.6 score on a scale
Standard Deviation 2.6
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Average Pain Intensity (Baseline)
|
6.5 score on a scale
Standard Deviation 1.8
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Average Pain Intensity (Posttest)
|
5.4 score on a scale
Standard Deviation 2.4
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Activity Interference (Baseline)
|
5.5 score on a scale
Standard Deviation 2.9
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Activity Interference (Posttest)
|
4.1 score on a scale
Standard Deviation 3.0
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Enjoyment Interference (Baseline)
|
5.8 score on a scale
Standard Deviation 2.7
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Pain, Enjoyment of Life and General Activity Scale (PEG)
Enjoyment Interference (Posttest)
|
3.8 score on a scale
Standard Deviation 3.0
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SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Applied Mindfulness Process Scale (AMPS) assesses how participants use mindfulness when facing challenges in daily life. Sum all 15 items to obtain a total score ranging from 0-60. Higher scores indicate higher utilization of mindfulness
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Applied Mindfulness Process Scale (AMPS)
Baseline
|
37.4 units on a scale
Standard Deviation 12.9
|
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Applied Mindfulness Process Scale (AMPS)
Post-test
|
43.0 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) rates a participant's broad conceptualization of mindfulness,. Minimum = 12 Maximum = 48. Higher values reflect higher levels of mindfulness.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Baseline
|
35.3 units on a scale
Standard Deviation 7.2
|
|
Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Post-test
|
36.0 units on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Perceived Stress Scale (PSS-4) assesses stress perception levels. Total sum of scores. Minimum = 0 Maximum =16; Higher scores are correlated to more stress.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Perceived Stress Scale (PSS-4)
Baseline
|
6.7 units on a scale
Standard Deviation 2.0
|
|
Perceived Stress Scale (PSS-4)
Post-test
|
5.6 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Post-Traumatic Checklist-Civilian Version-6 (PCL-C short form) assesses current Post Traumatic Stress Disorder symptoms. Items in the measure are scored on a scale of 1-5, with 5 indicating being extremely bothered by a problem (related to stressful experiences) in the past month, and 1 indicating not being bothered at all. The total score is a sum of all item responses; this can range from 6 - 30. Higher scores are suggestive of difficulties with post-traumatic stress, and further assessment and possibly referral for treatment may be indicated especially if a score is 14 or more.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)
Baseline
|
12.5 units on a scale
Standard Deviation 5.4
|
|
Post-Traumatic Checklist-Civilian Version-6 (PCL-C Short Form)
Post-test
|
11.8 units on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)Population: 23 participants provided this information at baseline, but only 19 participants provided it at posttest.
The Pittsburgh Sleep Quality Index (PSQI) is a four-question measure assessing sleep quality. This study ONLY utilized question 4 of the measure, which asks about sleep duration in hours and minutes per night (the time spent actually asleep, not just in bed). Reported below as an outcome is the mean hours of sleep reported by participants at baseline and posttest, i.e. the mean hours reported by participants as captured in Question 4 only of the PSQI measure.
Outcome measures
| Measure |
Experimental: GetActive+
n=23 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
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|---|---|
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Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration
Baseline
|
5.50 hours
Standard Deviation 1.98
|
|
Pittsburgh Sleep Quality Index (PSQI) - Sleep Duration
Posttest
|
6.23 hours
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a v1.0 assesses quality of sleep. Raw scores on the survey are converted to T scores, which are standardized scores based on the average in the population; a score of 50 would indicate meeting the T score for the average quality of sleep in the reference general population, with a standard deviation of 10. Higher T scores reflect greater sleep disturbance, and thus worse outcomes. The means reported are the mean T scores at the indicated timepoint.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
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PROMIS Sleep Disturbance - Short Form 6a v1.0
Baseline
|
55.6 T-score
Standard Deviation 9.3
|
|
PROMIS Sleep Disturbance - Short Form 6a v1.0
Post-test
|
52.2 T-score
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Everyday Discrimination Scale - Short (EDS-S) assesses the frequency of experiences of discrimination. Each item is scored on a scale of 0-5, with 0 indicating never experiencing that situation, and 5 indicating experiencing it almost every day. Responses are then summed across items, with final scores ranging from 0 - 25. Higher scores indicate greater frequency of discriminatory experiences.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
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Everyday Discrimination Scale - Short (EDS-S)
Baseline
|
2.9 units on a scale
Standard Deviation 3.5
|
|
Everyday Discrimination Scale - Short (EDS-S)
Post-test
|
2.5 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) assess substance use behaviors. No summary score. Each item is scored individually for each substance. For each item, higher scores indicate better outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Tobacco Use · Never
|
32 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Tobacco Use · Less than monthly
|
1 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Tobacco Use · Monthly
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Tobacco Use · Weekly
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Tobacco Use · Daily or almost daily
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Tobacco Use · Prefer not to respond
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Binge Drinking · Never
|
23 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Binge Drinking · Less than monthly
|
3 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Binge Drinking · Monthly
|
4 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Binge Drinking · Weekly
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Binge Drinking · Daily or almost daily
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Binge Drinking · Prefer not to respond
|
3 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Prescription Drug Use · Never
|
31 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Prescription Drug Use · Less than monthly
|
2 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Prescription Drug Use · Monthly
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Prescription Drug Use · Weekly
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Prescription Drug Use · Daily or almost daily
|
0 Participants
|
|
Tobacco, Alcohol, Prescription Medications, and Other Substance (TAPS)
Prescription Drug Use · Prefer not to respond
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)Contrast Avoidance Questionnaire - Shortened (CAQ-S) a measure of sustaining negative emotionality to protect against sudden shifts in emotion. Minimum = 8, Maximum = 40 with higher scores indicating worse outcomes.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Contrast Avoidance Questionnaire - Shortened (CAQ-S)
Baseline
|
13.7 units on a scale
Standard Deviation 6.1
|
|
Contrast Avoidance Questionnaire - Shortened (CAQ-S)
Post-test
|
12.9 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Patient Global Impression of Change (PGIC) measures changes in pain in response to treatment. Minimum = 0, Maximum = 6. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=31 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Patient Global Impression of Change (PGIC)
Very much improved
|
11 Participants
|
|
Patient Global Impression of Change (PGIC)
Much improved
|
7 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally improved
|
6 Participants
|
|
Patient Global Impression of Change (PGIC)
No change
|
5 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally worse
|
2 Participants
|
|
Patient Global Impression of Change (PGIC)
Much worse or very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Tampa Scale for Kinesiophobia-11 (TSK11) is an 11-item questionnaire that assesses fear avoidance and fear of activity. Summary score of total responses with Minimum = 11 and Maximum = 44. Higher scores indicate higher kinesiophobia.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Tampa Scale for Kinesiophobia-11 (TSK11)
Baseline
|
28.9 units on a scale
Standard Deviation 6.7
|
|
Tampa Scale for Kinesiophobia-11 (TSK11)
Post-test
|
25.5 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The UCLA-3 Loneliness Scale measures isolation / perceived lack of social connectedness. Minimum = 3, Maximum = 9. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
UCLA-3 Loneliness Scale
Baseline
|
5.1 units on a scale
Standard Deviation 2.0
|
|
UCLA-3 Loneliness Scale
Post-test
|
4.8 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Minimum = 0, maximum = 52. Higher scores indicate better outcome and a stronger ability to recognize stress and cope.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Measure of Current Status (MOCS)
Baseline
|
28.8 units on a scale
Standard Deviation 9.8
|
|
Measure of Current Status (MOCS)
Post-test
|
32.0 units on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Self-Compassion Scale - Short Form (SCS-SF) is the rate of a participant's amount of self-compassion. Scores are calculated by averaging the 12 items with Minimum = 1, Maximum = 5. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Self-Compassion Scale - Short Form (SCS-SF)
Baseline
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Self-Compassion Scale - Short Form (SCS-SF)
Post-test
|
3.6 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline (0 weeks), Post-test (1 week after intervention completion)The Gratitude Questionnaire (GQ-6) assesses the proneness to experience gratitude in daily life. All items individual items are scored from 1=strongly disagree to 7=strongly agree. The total score is a sum of all the items, with a minimum of 6 and maximum of 42. Higher scores indicate a greater amount of gratitude. Results are reported for baseline and posttest (timepoint indicated by the row title description)\>
Outcome measures
| Measure |
Experimental: GetActive+
n=32 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Gratitude Questionnaire (GQ-6)
Baseline
|
35.00 score on a scale
Standard Deviation 5.66
|
|
Gratitude Questionnaire (GQ-6)
Posttest
|
35.13 score on a scale
Standard Deviation 5.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-test (1 week after intervention completion)Qualitative information was collected from patients through one-on-one exit interviews assessing perceptions of intervention; these were completely qualitative (i.e. held through discussions and not by using surveys or structured questions, etc). The reported result is the number of participants who completed this optional exit interview after intervention completion.
Outcome measures
| Measure |
Experimental: GetActive+
n=33 Participants
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Qualitative Assessment of Intervention by Participants
|
32 Participants
|
Adverse Events
Experimental: GetActive+
Serious adverse events
| Measure |
Experimental: GetActive+
n=33 participants at risk
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
General disorders
Kidney Stones and Infection
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Psychiatric disorders
Suicide attempt, Command hallucinations for suicide
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Injury, poisoning and procedural complications
Adverse effect of drug or medicament
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
Other adverse events
| Measure |
Experimental: GetActive+
n=33 participants at risk
A mind-body program focused on increasing physical and emotional function in older adults with chronic musculoskeletal pain
GetActive+: This is a 10-week group mind body program focused on improving self- report, performance based and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increased in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain/injury
|
12.1%
4/33 • Number of events 6 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Musculoskeletal and connective tissue disorders
Fall on same level from slipping, tripping or stumbling
|
15.2%
5/33 • Number of events 5 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Blood and lymphatic system disorders
Severe Nosebleed (Epistaxis)
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Renal and urinary disorders
Kidney Stones
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Nervous system disorders
Syncopal Episode
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Musculoskeletal and connective tissue disorders
Fall on or from stairs or steps
|
6.1%
2/33 • Number of events 2 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Cardiac disorders
Thrombophlebitis
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Cardiac disorders
Arrhythmias
|
6.1%
2/33 • Number of events 3 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Musculoskeletal and connective tissue disorders
Fall from furniture
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Gastrointestinal disorders
Diverticulitis
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
|
Surgical and medical procedures
Concern regarding prior hip replacement
|
3.0%
1/33 • Number of events 1 • Adverse events were monitored for each participant over the course of their participation in the intervention (10 weeks) through posttest (which was 1 week after the intervention was completed). The total counts of adverse events reported here reflect the total counts of all the events of all study participants, taken over the duration of the study (which was 11 months long in total)
|
Additional Information
Ana-Maria Vranceanu, PhD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place