Trial Outcomes & Findings for Ancillary Study of the Lessening Incontinence With Low-impact Activity Study (NCT NCT04776720)
NCT ID: NCT04776720
Last Updated: 2023-09-07
Results Overview
Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance. Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Repeated change from baseline to 6 and 12 weeks
Results posted on
2023-09-07
Participant Flow
Participant milestones
| Measure |
Yoga Program
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
119
|
|
Overall Study
COMPLETED
|
101
|
109
|
|
Overall Study
NOT COMPLETED
|
20
|
10
|
Reasons for withdrawal
| Measure |
Yoga Program
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Overall Study
COVID Related
|
4
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Serious Adverse Event
|
0
|
1
|
|
Overall Study
Too Busy
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Family
|
2
|
2
|
|
Overall Study
No remote technology access
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Cannot tolerate intervention
|
1
|
0
|
|
Overall Study
Incomplete outcome data
|
6
|
1
|
Baseline Characteristics
Ancillary Study of the Lessening Incontinence With Low-impact Activity Study
Baseline characteristics by cohort
| Measure |
Yoga Program
n=121 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=119 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
83 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or PI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Total Urinary Incontinence Episodes
|
3.6 episodes per day
STANDARD_DEVIATION 2.5 • n=5 Participants
|
3.2 episodes per day
STANDARD_DEVIATION 1.9 • n=7 Participants
|
3.4 episodes per day
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Stress-Type Urinary Incontinence Episodes
|
1.4 episodes per day
STANDARD_DEVIATION 1.8 • n=5 Participants
|
1.4 episodes per day
STANDARD_DEVIATION 1.5 • n=7 Participants
|
1.4 episodes per day
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Urgency-Type Urinary Incontinence Episodes
|
2.1 episodes per day
STANDARD_DEVIATION 2.2 • n=5 Participants
|
1.7 episodes per day
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.9 episodes per day
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Incontinence Impact Questionnaire (IIQ)
|
100.4 units on a scale
STANDARD_DEVIATION 78.9 • n=5 Participants
|
101.6 units on a scale
STANDARD_DEVIATION 66.4 • n=7 Participants
|
101.0 units on a scale
STANDARD_DEVIATION 72.7 • n=5 Participants
|
|
Urogenital distress inventory-6 score (UDI)
|
39.1 units on a scale
STANDARD_DEVIATION 19.1 • n=5 Participants
|
28.5 units on a scale
STANDARD_DEVIATION 19.4 • n=7 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 19.2 • n=5 Participants
|
|
Patient Perception of BladderCondition (PPBC)
|
3.3 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Center for Epidemiologic Studies Depression Scale (CES-D)
|
10.1 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 8.1 • n=7 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
State/Trait Anxiety Inventory (STAI)--Trait
|
36.1 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
36.1 units on a scale
STANDARD_DEVIATION 10.5 • n=7 Participants
|
36.1 units on a scale
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Hospital Anxiety & Depression (HADS)--Anxiety score
|
5.3 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Perceived Stress Scale (PSS) score
|
13.0 units on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
13.3 units on a scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
13.2 units on a scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
PROMIS Physical 8B, T-Score
|
51.0 T-score
STANDARD_DEVIATION 6.2 • n=5 Participants
|
51.3 T-score
STANDARD_DEVIATION 6.8 • n=7 Participants
|
51.2 T-score
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
One-legged Balance Test
|
24.4 seconds
STANDARD_DEVIATION 9.9 • n=5 Participants
|
25.5 seconds
STANDARD_DEVIATION 8.7 • n=7 Participants
|
24.9 seconds
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Chair Stands (in 30 seconds)
|
12.6 chair stands
STANDARD_DEVIATION 3.9 • n=5 Participants
|
13.1 chair stands
STANDARD_DEVIATION 4.2 • n=7 Participants
|
12.9 chair stands
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
2-Minute Step Test
|
85.9 steps
STANDARD_DEVIATION 22.8 • n=5 Participants
|
88.5 steps
STANDARD_DEVIATION 26.1 • n=7 Participants
|
87.2 steps
STANDARD_DEVIATION 24.5 • n=5 Participants
|
|
Wake after sleep onset
|
24.4 Minutes
STANDARD_DEVIATION 29.2 • n=5 Participants
|
25.2 Minutes
STANDARD_DEVIATION 25.6 • n=7 Participants
|
24.8 Minutes
STANDARD_DEVIATION 27.4 • n=5 Participants
|
|
Total sleep time
|
7.1 hours
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.0 hours
STANDARD_DEVIATION 1.0 • n=7 Participants
|
7.0 hours
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI) total score
|
6.2 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in successive semi-tandem, tandem, and one-legged balance stand tests, in which their ability to hold each position for up to 30 seconds. Scoring is based on the number of seconds in which the participant is able to hold the one-legged balance position, ranging from 0 to 30. If a participant cannot make it through the semi-tandem and tandem stands, the one-legged balance will not be attempted. They will receive a score of zero for the one-legged balance. Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points
Outcome measures
| Measure |
Yoga Program
n=107 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=110 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in One-legged Balance Test (Winsorized)
|
1.34 seconds
Interval 0.52 to 2.16
|
1.53 seconds
Interval 0.72 to 2.35
|
PRIMARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life
Outcome measures
| Measure |
Yoga Program
n=105 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=106 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Chair Stands (in 30 Seconds)
|
1 chair stands
Interval 0.32 to 1.68
|
1.98 chair stands
Interval 1.3 to 2.66
|
PRIMARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in aerobic endurance. In this test of aerobic endurance for older adults, participants are asked to step in place as many times as possible in a 2 minute period, each time raising the knee to a level midway between the patella and iliac crest. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher scores indicating greater endurance.
Outcome measures
| Measure |
Yoga Program
n=104 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=109 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in 2-Minute Step Test
|
8.05 steps
Interval 4.58 to 11.51
|
9.03 steps
Interval 5.59 to 12.48
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in total score on Perceived Stress Scale (PSS), a 10-item measure of thoughts and feelings related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40; higher scores indicated greater perceived stress. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points
Outcome measures
| Measure |
Yoga Program
n=106 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=112 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Perceived Stress Scale (PSS) Score
|
-0.44 units on a scale
Interval -1.41 to 0.52
|
-0.72 units on a scale
Interval -1.68 to 0.24
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in total score on Center for Epidemiologic Studies Depression (CES-D) scale, a validated 20-item self-administered questionnaire measure that has been widely used in clinical trials, including trials of bladder interventions, and has been shown to be sensitive to change. Total scores range from 0 to 60, with higher scores indicate greater burden of depression symptoms. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points
Outcome measures
| Measure |
Yoga Program
n=107 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=112 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
|
-0.82 units on a scale
Interval -2.25 to 0.6
|
-0.52 units on a scale
Interval -1.93 to 0.9
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in somatic anxiety. Somatic anxiety (i.e., the affective component of anxiety believed to be related to autonomic physiological arousal response) is measured using the trait component of the Spielberger State Trait Anxiety Inventory (STAI), a 20-item self-administered measure validated in clinical populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points
Outcome measures
| Measure |
Yoga Program
n=107 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=112 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
|
-1.22 score on a scale
Interval -2.41 to -0.03
|
-1.34 score on a scale
Interval -2.52 to -0.17
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range 0-21, Higher score indicates lower quality of life
Outcome measures
| Measure |
Yoga Program
n=107 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=111 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
|
-0.21 units on a scale
Interval -0.72 to 0.3
|
-0.33 units on a scale
Interval -0.83 to 0.18
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in sleep disruption. Average time spent awake after initial sleep onset is also assessed using the Pittsburgh Sleep Diary, based on participant recordings of nocturnal awakenings after initially falling asleep. Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life.
Outcome measures
| Measure |
Yoga Program
n=104 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=108 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Wake After Sleep Onset (Winsorized)
|
-3.55 minutes
Interval -7.96 to 0.85
|
-6.96 minutes
Interval -11.3 to -2.61
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in global sleep quality. Subjective sleep quality is being assessed using the Pittsburgh Sleep Quality Index (PSQI), an 18-item validated questionnaire originally designed to assess sleep quality, latency, efficiency, and problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points
Outcome measures
| Measure |
Yoga Program
n=108 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=112 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
|
-0.37 units on a scale
Interval -0.78 to 0.04
|
-0.66 units on a scale
Interval -1.07 to -0.25
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 6 and 12 weeksPopulation: Number of participants with outcomes data
Assess change in average nightly sleep duration. Average total sleep duration is assessed using the Pittsburgh Sleep Diary is a daily self-report measure previously validated against actigraphy data, and used in multiple past studies of older adults. Change from baseline in Total sleep time. Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points.
Outcome measures
| Measure |
Yoga Program
n=104 Participants
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=109 Participants
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Change From Baseline in Total Sleep Time
|
0 hours
Interval -0.18 to 0.17
|
0.09 hours
Interval -0.08 to 0.27
|
Adverse Events
Yoga Program
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Physical Conditioning Program
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Yoga Program
n=121 participants at risk
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=119 participants at risk
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High Grade B-Cell Lymphoma Burkitt-Like Lymphoma Nos
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
Other adverse events
| Measure |
Yoga Program
n=121 participants at risk
The 3-month yoga intervention provides instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Yoga Practice Program: 3 month group yoga classes
|
Physical Conditioning Program
n=119 participants at risk
The 3-month physical conditioning program provides instruction and practice in a variety of exercises and stretches that have been designed by the study physical therapist.
Physical Conditioning Program: 3 month group physical conditioning classes
|
|---|---|---|
|
Cardiac disorders
Recurrent Atrial Fibrillation
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Eye disorders
Detached Retina
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Abdominal Cramps
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Gastrointestinal disorders
Dental Discomfort
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Gastrointestinal disorders
Epigastric Pain
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Food Poisoning
|
1.7%
2/121 • Number of events 2 • 9 months
|
1.7%
2/119 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Tooth Pain
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
General disorders
Facial Pain
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Immune system disorders
Allergy
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Immune system disorders
Allergy Nos
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Immune system disorders
Hay Fever
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Infections and infestations
Bladder Infection
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Infections and infestations
Bronchitis
|
0.83%
1/121 • Number of events 1 • 9 months
|
1.7%
2/119 • Number of events 2 • 9 months
|
|
Infections and infestations
Coronavirus Infection
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Infections and infestations
Ear Infection
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Infections and infestations
Lower Urinary Tract Infection
|
0.00%
0/121 • 9 months
|
1.7%
2/119 • Number of events 2 • 9 months
|
|
Infections and infestations
Mumps
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Infections and infestations
Shingles
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Infections and infestations
Tooth Infection
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Infections and infestations
Upper Respiratory Infection
|
3.3%
4/121 • Number of events 4 • 9 months
|
1.7%
2/119 • Number of events 2 • 9 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Injury, poisoning and procedural complications
Back Sprain
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Knee Injury
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Injury, poisoning and procedural complications
Lateral Epicondylitis
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Leg Fracture
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Injury, poisoning and procedural complications
Pulled Hamstring
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Shoulder Injury
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Injury, poisoning and procedural complications
Toe Injury
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Vaccination Adverse Reaction
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Investigations
Colonoscopy
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Investigations
Endoscopy
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back Muscle Spasms
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.83%
1/121 • Number of events 1 • 9 months
|
2.5%
3/119 • Number of events 3 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain; Knee Injury
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Frozen Shoulder
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Groin Discomfort
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Hand Pain
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Hip Arthrosis
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Hip Discomfort
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
4.1%
5/121 • Number of events 5 • 9 months
|
2.5%
3/119 • Number of events 3 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Knee Swelling
|
3.3%
4/121 • Number of events 4 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.83%
1/121 • Number of events 1 • 9 months
|
1.7%
2/119 • Number of events 2 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar Pain
|
1.7%
2/121 • Number of events 2 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Soreness
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain Ankle
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Ankle
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Elbow
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Hip
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Injury
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Deformity Nos
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
3.3%
4/121 • Number of events 4 • 9 months
|
3.4%
4/119 • Number of events 4 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder Soreness
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder Nos
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma In Situ
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Nervous system disorders
Dizziness
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Nervous system disorders
Headache
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Nervous system disorders
Localised Numbness
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Nervous system disorders
Migraine, Unspecified
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Nervous system disorders
Neck Numbness
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Nervous system disorders
Sciatica Aggravated
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Stress
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Aggravated
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Attack
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Skin and subcutaneous tissue disorders
Cyst Epidermal
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Skin and subcutaneous tissue disorders
Neck Rash
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Back Surgery
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Surgical and medical procedures
Bladder Sling Procedure
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Bunionectomy
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Surgical and medical procedures
Oral Surgery
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
|
Surgical and medical procedures
Shoulder Replacement
|
0.00%
0/121 • 9 months
|
0.84%
1/119 • Number of events 1 • 9 months
|
|
Vascular disorders
Hot Flashes
|
0.83%
1/121 • Number of events 1 • 9 months
|
0.00%
0/119 • 9 months
|
Additional Information
Alison Huang, MD, MAS, MPhil
University of California, San Francisco
Phone: 415-353-7900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place