Trial Outcomes & Findings for Technology Interventions to Improve Outcomes After Knee Replacement (NCT NCT04482400)
NCT ID: NCT04482400
Last Updated: 2026-03-27
Results Overview
sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
2 months
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
NEAT!2
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
41
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Technology Interventions to Improve Outcomes After Knee Replacement
Baseline characteristics by cohort
| Measure |
NEAT!2
n=42 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=41 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.8 • n=56 Participants
|
65.1 years
STANDARD_DEVIATION 9.0 • n=62 Participants
|
65.3 years
STANDARD_DEVIATION 9.4 • n=123 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=56 Participants
|
30 Participants
n=62 Participants
|
62 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=56 Participants
|
11 Participants
n=62 Participants
|
21 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=56 Participants
|
41 Participants
n=62 Participants
|
83 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=56 Participants
|
8 Participants
n=62 Participants
|
19 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=56 Participants
|
33 Participants
n=62 Participants
|
64 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Percentage of time spent in Sedentary Behavior
|
73.26 percentage of time in sedentary behavior
STANDARD_DEVIATION 7.47 • n=56 Participants
|
74.13 percentage of time in sedentary behavior
STANDARD_DEVIATION 6.17 • n=62 Participants
|
73.68 percentage of time in sedentary behavior
STANDARD_DEVIATION 6.84 • n=123 Participants
|
PRIMARY outcome
Timeframe: 2 monthssedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Objectively Measured (Actigraph) Sedentary Behavior at 2 Months
|
659.52 minutes/day
Standard Deviation 75.70
|
638.24 minutes/day
Standard Deviation 75.56
|
PRIMARY outcome
Timeframe: 5 monthssedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Objectively Measured (Actigraph) Sedentary Behavior at 5 Months
|
674.17 minutes/day
Standard Deviation 77.60
|
638.62 minutes/day
Standard Deviation 78.31
|
SECONDARY outcome
Timeframe: 5 months after surgerySix minute walk test - the number of feet an individual can walk in 6 minutes.
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Physical Function
|
1338.67 feet
Standard Deviation 271.20
|
1340.04 feet
Standard Deviation 342.75
|
SECONDARY outcome
Timeframe: 5 months after surgeryWOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
WOMAC Pain Subscale
|
3.05 score on a scale
Standard Deviation 3.47
|
3.0 score on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: 5 months after surgeryobjectively measured light, moderate and vigorous activity (\>= 100 counts/min) by Actigraph accelerometers
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Total Physical Activity Measured by Actigraph Accelerometers
|
1532.41 minutes/week
Standard Deviation 510.40
|
1442.08 minutes/week
Standard Deviation 478.67
|
SECONDARY outcome
Timeframe: 2 monthsNumber of calls completed
Outcome measures
| Measure |
NEAT!2
n=42 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=41 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Adherence to Calls
|
4.8 calls completed
Standard Deviation 0.6
|
4.8 calls completed
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Participants in NEAT!2 were included in analyses of the adherence to the NEAT!2 app. The MyKneeGuide participants did not receive the app, thus, the total days of adherence could not be calculated.
total days NEAT! app was used
Outcome measures
| Measure |
NEAT!2
n=42 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Adherence to NEAT!2 App
|
40.3 days
Standard Deviation 13.82
|
—
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Participants in NEAT!2 were included in analyses of the response to NEAT!2 prompts. The MyKneeGuide participants did not receive the app, thus, response of NEAT!2 prompts could not be calculated.
percentage of notifications in which a transition from sitting to standing was detected
Outcome measures
| Measure |
NEAT!2
n=42 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Response to NEAT!2 Prompts
|
9.7 percentage of notifications w/response
Standard Deviation 7.8
|
—
|
SECONDARY outcome
Timeframe: 5 months after surgeryChair stand test - how many times a participant can stand up and sit down in 30 seconds
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Physical Function Via Chair Stand Test
|
10.59 repetitions
Standard Deviation 2.71
|
10.39 repetitions
Standard Deviation 2.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 months after surgeryTimed up and go test - How fast a participant can stand up, walk around a cone, and return back to the chair and sit.
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Physical Function Via Timed up and go
|
9.22 seconds
Standard Deviation 2.06
|
9.51 seconds
Standard Deviation 2.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsKnee Injury and Osteoarthritis Outcome Score (KOOS) pain subcale (0 indicates extreme problems, 100 no problems)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Knee Symptoms - KOOS Pain
|
81.03 score on a scale
Standard Deviation 16.62
|
81.87 score on a scale
Standard Deviation 16.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 monthsKnee Injury and Osteoarthritis Outcome Score (KOOS) symptoms subcale (0 indicates extreme problems, 100 no problems)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Knee Symptoms - KOOS Symptoms
|
74.04 score on a scale
Standard Deviation 17.98
|
72.95 score on a scale
Standard Deviation 17.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsKnee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) subscale (0 indicates extreme problems, 100 no problems)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Knee Symptoms - KOOS ADL
|
83.46 score on a scale
Standard Deviation 14.41
|
83.44 score on a scale
Standard Deviation 14.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsKnee Injury and Osteoarthritis Outcome Score (KOOS) sport/recreation subcale (0 indicates extreme problems, 100 no problems)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Knee Symptoms - KOOS Sport/Rec
|
66.34 score on a scale
Standard Deviation 27.04
|
69.61 score on a scale
Standard Deviation 24.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsKnee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subcale (0 indicates extreme problems, 100 no problems)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Knee Symptoms - KOOS QoL
|
66.62 score on a scale
Standard Deviation 21.04
|
64.14 score on a scale
Standard Deviation 22.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsminutes/day in sedentary time as assessed by activPAL accelerometer worn for 7 days on the thigh
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Sedentary Time Via activPAL Accelerometers
|
629.05 minutes/day
Standard Deviation 109.06
|
615.36 minutes/day
Standard Deviation 116.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsPatient-Reported Outcomes Measurement Information System (PROMIS) - T score (50 indicates the population mean with a \*standard deviation of 10) - (scores higher than 50 represent better function and mobility)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Patient Reported Outcomes - Mobility - T-Score
|
43.16 T-score
Standard Deviation 5.79
|
43.42 T-score
Standard Deviation 5.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsPatient-Reported Outcomes Measurement Information System (PROMIS) Global Health - T score (50 indicates the population mean with a standard deviation of 10) (scores higher than 50 represent better health)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Patient Reported Outcomes - Global Health - T-Score
|
49.28 T Score
Standard Deviation 9.03
|
48.94 T Score
Standard Deviation 8.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsPatient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance - T score (50 indicates the population mean with a standard deviation of 10) (scores higher than 50 represent worse sleep disturbance)
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Patient Reported Outcomes - Sleep Disturbance - T-Score
|
47.90 T-Score
Standard Deviation 8.72
|
48.31 T-Score
Standard Deviation 7.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 monthsSelf-reported sitting time on weekday in hours/day as assessed by the SIT-Q survey
Outcome measures
| Measure |
NEAT!2
n=41 Participants
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=38 Participants
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Sedentary Time Via SIT-Q
|
9.98 hours/day
Standard Deviation 3.77
|
10.15 hours/day
Standard Deviation 4.89
|
Adverse Events
NEAT!2
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
MyKneeGuide
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NEAT!2
n=42 participants at risk
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=41 participants at risk
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Gastrointestinal disorders
Gall bladder surgery
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
|
Cardiac disorders
Coronary blockage
|
0.00%
0/42 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
Other adverse events
| Measure |
NEAT!2
n=42 participants at risk
Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2: 8 week sedentary reduction program
|
MyKneeGuide
n=41 participants at risk
Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
MyKneeGuide: 8 week surgery recovery education program
|
|---|---|---|
|
Cardiac disorders
High blood pressure
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
mass removal
|
0.00%
0/42 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
|
Musculoskeletal and connective tissue disorders
back injury/pain
|
9.5%
4/42 • Number of events 4 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Musculoskeletal and connective tissue disorders
Fall
|
14.3%
6/42 • Number of events 7 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
|
Musculoskeletal and connective tissue disorders
knee injury
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Ear and labyrinth disorders
vertigo
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Musculoskeletal and connective tissue disorders
spinal stenosis
|
2.4%
1/42 • Number of events 1 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
|
Musculoskeletal and connective tissue disorders
shoulder injury
|
4.8%
2/42 • Number of events 2 • 5 months
adverse events among randomized participants
|
0.00%
0/41 • 5 months
adverse events among randomized participants
|
|
Musculoskeletal and connective tissue disorders
hip injury
|
0.00%
0/42 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
|
Vascular disorders
venous insufficiency
|
0.00%
0/42 • 5 months
adverse events among randomized participants
|
2.4%
1/41 • Number of events 1 • 5 months
adverse events among randomized participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place