Trial Outcomes & Findings for Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis (NCT NCT02312713)
NCT ID: NCT02312713
Last Updated: 2017-10-27
Results Overview
Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
baseline, 4 months, and 12 months
Results posted on
2017-10-27
Participant Flow
Participant milestones
| Measure |
Standard Physical Therapy
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
no intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
140
|
142
|
68
|
|
Overall Study
COMPLETED
|
129
|
112
|
63
|
|
Overall Study
NOT COMPLETED
|
11
|
30
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Therapy Versus Internet-Based Exercise Training for Patients With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Body Mass Index
|
31.9 kg/m2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 7.8 • n=7 Participants
|
30.1 kg/m2
STANDARD_DEVIATION 7.3 • n=5 Participants
|
31.4 kg/m2
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Married or Living with Partner
|
80 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Bachelors Degree or More Education
|
86 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Employed
|
59 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Low Income Financial Status
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Fair or Poor Self-Reported Health
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Number of Joints with Arthritis Symptoms
|
5.5 joints
STANDARD_DEVIATION 3.0 • n=5 Participants
|
5.2 joints
STANDARD_DEVIATION 3.1 • n=7 Participants
|
5.5 joints
STANDARD_DEVIATION 3.9 • n=5 Participants
|
5.4 joints
STANDARD_DEVIATION 3.2 • n=4 Participants
|
|
Self-reported Years with Arthritis Symptoms
|
14.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
11.6 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 months, and 12 monthsChange over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
Baseline to 4 Month Change
|
-6.73 units on a scale
Interval -8.86 to -4.6
|
-6.06 units on a scale
Interval -8.29 to -3.84
|
-3.37 units on a scale
Interval -6.33 to -0.41
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score
Baseline to 12 Month Change
|
-4.42 units on a scale
Interval -6.66 to -2.17
|
-5.46 units on a scale
Interval -7.82 to -3.09
|
-2.83 units on a scale
Interval -5.93 to 0.27
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsThis is a validated, 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale
Baseline to 4 Month Change
|
0.84 units on a scale
Interval 0.6 to 1.09
|
0.35 units on a scale
Interval 0.09 to 0.61
|
0.28 units on a scale
Interval -0.07 to 0.63
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale
Baseline to 12 Month Change
|
0.39 units on a scale
Interval 0.14 to 0.64
|
0.43 units on a scale
Interval 0.16 to 0.7
|
0.16 units on a scale
Interval -0.19 to 0.51
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsOne of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test
Baseline to 4 Month Change
|
-0.68 number of steps taken in 2 minutes
Interval -5.07 to 3.71
|
-3.54 number of steps taken in 2 minutes
Interval -8.2 to 1.11
|
-8.43 number of steps taken in 2 minutes
Interval -14.61 to -2.24
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test
Baseline to 12 Month Change
|
1.11 number of steps taken in 2 minutes
Interval -3.45 to 5.67
|
1.12 number of steps taken in 2 minutes
Interval -3.76 to 6.0
|
0.00 number of steps taken in 2 minutes
Interval -6.49 to 6.48
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsOne of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time
Baseline to 4 Month Change
|
-0.59 seconds
Interval -1.15 to -0.03
|
0.02 seconds
Interval -0.57 to 0.61
|
0.04 seconds
Interval -0.75 to 0.82
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time
Baseline to 12 Month Change
|
-0.05 seconds
Interval -0.6 to 0.5
|
-0.05 seconds
Interval -0.64 to 0.53
|
-0.09 seconds
Interval -0.88 to 0.69
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsOne of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand
Baseline to 4 Month Change
|
-0.13 number of stands from a chair in 30 sec
Interval -0.87 to 0.61
|
0.50 number of stands from a chair in 30 sec
Interval -0.29 to 1.28
|
0.18 number of stands from a chair in 30 sec
Interval -0.87 to 1.23
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand
Baseline to 12 Month Change
|
0.16 number of stands from a chair in 30 sec
Interval -0.49 to 0.82
|
0.90 number of stands from a chair in 30 sec
Interval 0.2 to 1.6
|
0.66 number of stands from a chair in 30 sec
Interval -0.27 to 1.58
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsOne of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go
Baseline to 4 Month Change
|
-0.62 seconds
Interval -1.34 to 0.09
|
-0.87 seconds
Interval -1.63 to -0.11
|
-0.23 seconds
Interval -1.24 to 0.78
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go
Baseline to 12 Month Change
|
-0.77 seconds
Interval -1.57 to 0.04
|
-1.49 seconds
Interval -2.35 to -0.63
|
-0.26 seconds
Interval -1.4 to 0.87
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsDepressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8
Baseline to 4 Month Change
|
-0.46 units on a scale
Interval -0.94 to 0.02
|
-0.22 units on a scale
Interval -0.73 to 0.29
|
0.33 units on a scale
Interval -0.36 to 1.01
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8
Baseline to 12 Month Change
|
0.1 units on a scale
Interval -0.45 to 0.65
|
0.1 units on a scale
Interval -0.49 to 0.69
|
0.99 units on a scale
Interval 0.22 to 1.77
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsThe KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 4 Month Change - KOOS ADL
|
6.8 units on a scale
Interval 4.53 to 9.06
|
5.47 units on a scale
Interval 3.08 to 7.87
|
3.37 units on a scale
Interval 0.16 to 6.57
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 4 Month Change - KOOS Pain
|
6.2 units on a scale
Interval 3.75 to 8.65
|
7.77 units on a scale
Interval 5.17 to 10.38
|
3.84 units on a scale
Interval 0.38 to 7.29
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 12 Month Change - KOOS Pain
|
3.67 units on a scale
Interval 1.05 to 6.29
|
6.18 units on a scale
Interval 3.38 to 8.98
|
2.82 units on a scale
Interval -0.86 to 6.5
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 12 Month Change - KOOS ADL
|
4.65 units on a scale
Interval 2.3 to 7.01
|
4.99 units on a scale
Interval 2.48 to 7.49
|
2.2 units on a scale
Interval -1.1 to 5.5
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 4 Month Change - KOOS Sport/Rec
|
5.6 units on a scale
Interval 2.44 to 8.77
|
5.4 units on a scale
Interval 2.03 to 8.77
|
1.69 units on a scale
Interval -2.82 to 6.2
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 12 Month Change - KOOS Sport/Rec
|
5.44 units on a scale
Interval 2.07 to 8.8
|
5.98 units on a scale
Interval 2.33 to 9.64
|
-0.03 units on a scale
Interval -4.76 to 4.7
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 4 Month Change - KOOS QOL
|
5.56 units on a scale
Interval 2.93 to 8.19
|
5.9 units on a scale
Interval 3.11 to 8.69
|
2.27 units on a scale
Interval -1.45 to 5.99
|
|
Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline to 12 Month Change - KOOS QOL
|
4.21 units on a scale
Interval 1.64 to 6.78
|
6.8 units on a scale
Interval 4.06 to 9.54
|
-0.93 units on a scale
Interval -4.53 to 2.66
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsThe PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument
Baseline to 4 Month Change
|
-3.13 units on a scale
Interval -4.37 to -1.89
|
-0.94 units on a scale
Interval -2.26 to 0.38
|
-0.54 units on a scale
Interval -2.32 to 1.23
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument
Baseline to 12 Month Change
|
-2.16 units on a scale
Interval -3.47 to -0.86
|
-0.45 units on a scale
Interval -1.84 to 0.94
|
-1.1 units on a scale
Interval -2.93 to 0.72
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsThe PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument
Baseline to 12 Month Change
|
0.09 units on a scale
Interval -1.05 to 1.24
|
0.88 units on a scale
Interval -0.35 to 2.1
|
2.52 units on a scale
Interval 0.93 to 4.12
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument
Baseline to 4 Month Change
|
-0.91 units on a scale
Interval -2.21 to 0.38
|
0.57 units on a scale
Interval -0.81 to 1.94
|
1.55 units on a scale
Interval 0.31 to 3.42
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsThe Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." The score ranges from 0-24 with higher scores indicating more fear of movement.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale
Baseline to 4 Month Change
|
-0.34 units on a scale
Interval -0.84 to 0.15
|
0.01 units on a scale
Interval -0.52 to 0.53
|
0.45 units on a scale
Interval -0.26 to 1.15
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale
Baseline to 12 Month Change
|
0.28 units on a scale
Interval -0.19 to 0.74
|
0.06 units on a scale
Interval -0.44 to 0.56
|
0.28 units on a scale
Interval -0.37 to 0.93
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsThe Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults. The typical range for the total PASE score is 0-400, with higher scores indicating greater activity.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)
Baseline to 4 Month Change
|
2.25 units on a scale
Interval -9.18 to 13.68
|
-11.52 units on a scale
Interval -23.79 to 0.74
|
-4.7 units on a scale
Interval -21.04 to 11.64
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)
Baseline to 12 Month Change
|
8.28 units on a scale
Interval -2.01 to 18.56
|
8.19 units on a scale
Interval -2.99 to 19.37
|
1.17 units on a scale
Interval -13.11 to 15.45
|
SECONDARY outcome
Timeframe: baseline, 4 months, and 12 monthsNumber of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity.
Outcome measures
| Measure |
Standard Physical Therapy
n=140 Participants
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 Participants
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 Participants
no intervention
|
|---|---|---|---|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Baseline to 4 Month Change - Strengthening Exercis
|
1.78 minutes per week
Interval 0.99 to 2.57
|
1.27 minutes per week
Interval 0.44 to 2.11
|
0.43 minutes per week
Interval -0.69 to 1.54
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Baseline to 12 Month Change - Strengthening Exerc
|
1.07 minutes per week
Interval 0.23 to 1.91
|
1.21 minutes per week
Interval 0.32 to 2.1
|
-0.14 minutes per week
Interval -1.32 to 1.04
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Baseline to 4 Month Change - Stretching
|
1.45 minutes per week
Interval 0.76 to 2.15
|
0.97 minutes per week
Interval 0.23 to 1.72
|
-0.4 minutes per week
Interval -1.39 to 0.6
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Baseline to 12 Month Change - Stretching
|
0.27 minutes per week
Interval -0.37 to 0.92
|
0.72 minutes per week
Interval 0.04 to 1.41
|
-1.34 minutes per week
Interval -2.24 to -0.44
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Baseline to 4 Month Change - Aerobic Exercises
|
1 minutes per week
Interval -0.02 to 2.02
|
1.79 minutes per week
Interval 0.71 to 2.88
|
-0.09 minutes per week
Interval -1.53 to 1.35
|
|
Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items
Baseline to 12 Month Change - Aerobic Exercises
|
0.48 minutes per week
Interval -0.67 to 1.63
|
0.41 minutes per week
Interval -0.82 to 1.63
|
-1.59 minutes per week
Interval -3.21 to 0.04
|
Adverse Events
Standard Physical Therapy
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Internet Based Exercise Training
Serious events: 12 serious events
Other events: 0 other events
Deaths: 2 deaths
Wait List Control
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Physical Therapy
n=140 participants at risk
Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
Physical Therapy: Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
|
Internet Based Exercise Training
n=142 participants at risk
Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
Internet Based Exercise Training: Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be "semi-standardized," meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content.
|
Wait List Control
n=68 participants at risk
no intervention
|
|---|---|---|---|
|
Infections and infestations
Osteomyelitis of left foot
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Blood and lymphatic system disorders
Chronic Leukemia
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Vascular disorders
Pulmonary Embolism
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath, CHF exacerbation, pneumonia
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Gastrointestinal disorders
Left femoral hernia resulting in small bowel obstruction
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Posterior Lumbar Decompression & Fusion Surgery
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Cardiac disorders
Heart Blockage
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
2.9%
2/68 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage 1 Uterine Cancer
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Total Knee Replacement
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Nervous system disorders
Presyncope
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Cataract Surgery
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Nervous system disorders
Syncope
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Pacemaker implant for Sick sinus syndrome
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Injury, poisoning and procedural complications
Odontoid fracture
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Infections and infestations
Sepsis from E.Coli UTI
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Injury, poisoning and procedural complications
C1 Cervical Fracture
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Laproscopy w/total hysterectomy
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Laparoscopic cholecystectomy for cholelithiasis
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.5%
1/68 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Infections and infestations
Appendicitis with peritoneal abscess
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Infections and infestations
MRSA bacteremia
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Immune system disorders
Anaphylaxis after insect bites
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Injury, poisoning and procedural complications
Fall with fracture of right shoulder and right wrist pain
|
0.71%
1/140 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/142 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Infections and infestations
C. Diff Colitis
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Nervous system disorders
Stroke
|
0.00%
0/140 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.70%
1/142 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/68 • Data were collected for 12 months, ending at participants' final follow up time point.
|
Other adverse events
Adverse event data not reported
Additional Information
Kelli Allen
University of North Carolina at Chapel HIll
Phone: 919-966-0558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place