Trial Outcomes & Findings for Delaware Physical Exercise and Activity for Knee Osteoarthritis (NCT NCT04980300)
NCT ID: NCT04980300
Last Updated: 2025-01-01
Results Overview
Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome
Results posted on
2025-01-01
Participant Flow
Participant milestones
| Measure |
Expanded Intervention
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Brief Intervention
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Baseline to 12 Weeks
STARTED
|
51
|
52
|
|
Baseline to 12 Weeks
COMPLETED
|
45
|
51
|
|
Baseline to 12 Weeks
NOT COMPLETED
|
6
|
1
|
|
12 Weeks to 24 Weeks
STARTED
|
45
|
51
|
|
12 Weeks to 24 Weeks
COMPLETED
|
41
|
46
|
|
12 Weeks to 24 Weeks
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Expanded Intervention
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Brief Intervention
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Baseline to 12 Weeks
Withdrawal by Subject
|
2
|
1
|
|
Baseline to 12 Weeks
Lost to Follow-up
|
4
|
0
|
|
12 Weeks to 24 Weeks
Withdrawal by Subject
|
2
|
1
|
|
12 Weeks to 24 Weeks
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
Delaware Physical Exercise and Activity for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Expanded Intervention
n=51 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Brief Intervention
n=52 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Weight
|
96.4 kilograms
STANDARD_DEVIATION 23.1 • n=5 Participants
|
95.9 kilograms
STANDARD_DEVIATION 22.1 • n=7 Participants
|
96.2 kilograms
STANDARD_DEVIATION 22.5 • n=5 Participants
|
|
Height
|
1.7 Meters
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.6 Meters
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.7 Meters
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Body Mass Index
|
34.4 Kg/m squared
STANDARD_DEVIATION 7.8 • n=5 Participants
|
35.7 Kg/m squared
STANDARD_DEVIATION 8.4 • n=7 Participants
|
35.0 Kg/m squared
STANDARD_DEVIATION 8.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcomePopulation: For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.
Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA
Outcome measures
| Measure |
Intervention
n=41 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=47 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Moderate-to-vigorous Intensity Physical Activity
12 weeks - Baseline
|
0.7 min/day of MVPA
Interval -4.8 to 6.2
|
2.6 min/day of MVPA
Interval -2.6 to 7.7
|
|
Change in Moderate-to-vigorous Intensity Physical Activity
24 weeks - Baseline
|
2.7 min/day of MVPA
Interval -2.9 to 8.2
|
1.6 min/day of MVPA
Interval -3.6 to 6.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat (ITT) sample, which included all subjects who were randomized.
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Treatment Beliefs of Physical Therapy: Positive
12 weeks - Baseline
|
1.0 units on a scale
Interval -0.7 to 2.8
|
0.4 units on a scale
Interval -2.1 to 1.3
|
|
Change in Treatment Beliefs of Physical Therapy: Positive
24 weeks - Baseline
|
0.4 units on a scale
Interval -1.4 to 2.2
|
-0.6 units on a scale
Interval -2.2 to 1.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Treatment Beliefs of Physical Exercise: Positive
12 weeks - Baseline
|
1.3 units on a scale
Interval -0.6 to 3.2
|
0.0 units on a scale
Interval -1.8 to 1.8
|
|
Change in Treatment Beliefs of Physical Exercise: Positive
24 weeks - Baseline
|
1.2 units on a scale
Interval -0.7 to 3.1
|
-0.4 units on a scale
Interval -2.2 to 1.4
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.
Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes).
Outcome measures
| Measure |
Intervention
n=41 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=47 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Light Intensity Physical Activity (LPA)
12 weeks - Baseline
|
3.8 min/day
Interval -22.6 to 30.2
|
2.6 min/day
Interval -22.0 to 27.3
|
|
Change in Light Intensity Physical Activity (LPA)
24 weeks - Baseline
|
-3.4 min/day
Interval -30.0 to 23.1
|
-13.1 min/day
Interval -38.0 to 11.7
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.
Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for \> 4 days.
Outcome measures
| Measure |
Intervention
n=41 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=47 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Steps/Day
12 weeks - Baseline
|
517.5 Steps/day
Interval -252.8 to 1287.8
|
259.0 Steps/day
Interval -462.2 to 980.1
|
|
Change in Steps/Day
24 weeks - Baseline
|
269.3 Steps/day
Interval -505.7 to 1044.4
|
-206.5 Steps/day
Interval -933.6 to 520.5
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Treatment Beliefs of Physical Therapy: Negative
12 weeks - Baseline
|
-0.6 units on a scale
Interval -1.9 to 0.6
|
1.0 units on a scale
Interval -0.2 to 2.1
|
|
Change in Treatment Beliefs of Physical Therapy: Negative
24 weeks - Baseline
|
-1.0 units on a scale
Interval -2.2 to 0.3
|
0.5 units on a scale
Interval -0.6 to 1.7
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Change in Treatment Beliefs of Physical Exercise: Negative
24 weeks - Baseline
|
-1.0 units on a scale
Interval -2.2 to 0.3
|
0.5 units on a scale
Interval -0.6 to 1.7
|
|
Change in Treatment Beliefs of Physical Exercise: Negative
12 weeks - Baseline
|
-0.6 units on a scale
Interval -1.9 to 0.6
|
1.0 units on a scale
Interval -0.2 to 2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
Change in knee pain will be measured using a single-item Visual Analog Scale (VAS) question in which the participant will indicate their pain in each knee. Scores range from 0-100 where 0 is no pain and 100 is the worst pain imaginable. An index knee to be used for analysis is defined as the knee with worse pain at baseline. Scores of the Knee pain Visual Analogue Scale are on a scale of 0 to 100 with higher scores mean worse outcome, i.e., more pain
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale)
24 weeks - Baseline
|
-25.7 units on a scale
Interval -36.8 to -14.7
|
-14.2 units on a scale
Interval -24.5 to -3.8
|
|
Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale)
12 weeks - Baseline
|
-29.7 units on a scale
Interval -40.5 to -18.9
|
-8.8 units on a scale
Interval -19.1 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Pain, min 0, max 100, with higher scores representing a better outcome
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale
12 weeks - Baseline
|
10.6 units on a scale
Interval 5.0 to 16.2
|
3.7 units on a scale
Interval -1.5 to 8.9
|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale
24 weeks - Baseline
|
10.0 units on a scale
Interval 4.3 to 15.6
|
3.8 units on a scale
Interval -1.5 to 9.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and after randomizationThe participant will complete a Treatment Expectations Question, which asks the participant how effective they expect the intervention to be for their knee. This question will be collected at the baseline timepoint: right before and right after randomization. Answers will be expressed as frequencies and percentages for each of the following categories: No effect at all, Minimal improvement, Moderate improvement, Large improvement, and Complete recovery, as well as reported as an increase, decrease, or no change in treatment expectations. Score ranges from 1 to 5 with higher scores representing higher expectations of improvement following treatment.
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Treatment Expectations
Post-Randomization
|
3.0 units on a scale
Standard Deviation 0.7
|
2.6 units on a scale
Standard Deviation 0.7
|
|
Exploratory Outcome: Change in Treatment Expectations
Pre-Randomization
|
3.1 units on a scale
Standard Deviation 0.7
|
3.1 units on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks and 24 weeksFor the Expanded Intervention, adherence to strengthening exercises and physical activity will be measured using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence.
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS)
12 weeks
|
15.1 units on a scale
Standard Deviation 6.1
|
—
|
|
Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS)
24 weeks
|
11.1 units on a scale
Standard Deviation 6.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Symptoms, min 0, max 100, with higher scores representing a better outcome
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale
12 weeks - Baseline
|
6.0 units on a scale
Interval 1.2 to 10.9
|
2.2 units on a scale
Interval -2.4 to 6.8
|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale
24 weeks - Baseline
|
5.8 units on a scale
Interval 0.9 to 10.7
|
0.6 units on a scale
Interval -4.0 to 5.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS ADL, min 0, max 100, with higher scores representing a better outcome
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale
24 weeks - Baseline
|
9.5 units on a scale
Interval 3.3 to 15.7
|
4.9 units on a scale
Interval -0.9 to 10.7
|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale
12 weeks - Baseline
|
12.5 units on a scale
Interval 6.3 to 18.6
|
4.4 units on a scale
Interval -1.4 to 10.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Sports and Recreation, min 0, max 100, with higher scores representing a better outcome
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale
12 weeks - Baseline
|
15.2 units on a scale
Interval 2.8 to 27.7
|
4.0 units on a scale
Interval -7.8 to 15.7
|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale
24 weeks - Baseline
|
7.0 units on a scale
Interval -5.6 to 19.6
|
3.7 units on a scale
Interval -8.0 to 15.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: We analyzed our intention to treat sample, which included all subjects who were randomized.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport \& Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems. KOOS Quality of Life, min 0, max 100, with higher scores representing a better outcome
Outcome measures
| Measure |
Intervention
n=45 Participants
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Intervention: Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Control
n=51 Participants
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Control: Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale
12 weeks - Baseline
|
14.4 units on a scale
Interval 7.7 to 21.2
|
5.2 units on a scale
Interval -1.2 to 11.5
|
|
Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale
24 weeks - Baseline
|
15.1 units on a scale
Interval 8.3 to 21.9
|
4.5 units on a scale
Interval -1.9 to 10.8
|
Adverse Events
Expanded Intervention
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Brief Intervention
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Expanded Intervention
n=51 participants at risk
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Brief Intervention
n=52 participants at risk
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
0.00%
0/51 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
5.8%
3/52 • Number of events 3 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
Other adverse events
| Measure |
Expanded Intervention
n=51 participants at risk
Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Expanded Intervention: Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
|
Brief Intervention
n=52 participants at risk
Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.
Brief Intervention: Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back
|
9.8%
5/51 • Number of events 5 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
0.00%
0/52 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
|
Musculoskeletal and connective tissue disorders
Hip/Thigh
|
7.8%
4/51 • Number of events 4 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
0.00%
0/52 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
|
Musculoskeletal and connective tissue disorders
Knee
|
9.8%
5/51 • Number of events 5 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
9.6%
5/52 • Number of events 5 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
|
Musculoskeletal and connective tissue disorders
Ankle/Foot
|
9.8%
5/51 • Number of events 5 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
0.00%
0/52 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
|
Musculoskeletal and connective tissue disorders
Other
|
49.0%
25/51 • Number of events 25 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
9.6%
5/52 • Number of events 5 • Adverse events were collected from study enrollment until study completion at the 24 week follow up.
The study team may become aware of an AE through spontaneous report of the patient (e.g., via phone call or email), or through scheduled intervention consultations for participants in the Expanded intervention group. Adverse events were collected from study enrollment until study completion at the 24 week follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place