Trial Outcomes & Findings for Group Physical Therapy for Knee Osteoarthritis (NCT NCT01058304)
NCT ID: NCT01058304
Last Updated: 2015-04-14
Results Overview
WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms. Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
320 participants
Primary outcome timeframe
12-weeks, 24-weeks
Results posted on
2015-04-14
Participant Flow
Participant milestones
| Measure |
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
161
|
|
Overall Study
COMPLETED
|
132
|
128
|
|
Overall Study
NOT COMPLETED
|
27
|
33
|
Reasons for withdrawal
| Measure |
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
13
|
16
|
|
Overall Study
Developed exclusion criterion
|
6
|
12
|
Baseline Characteristics
Group Physical Therapy for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Group Physical Therapy for Knee OA
n=159 Participants
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Individual Physical Therapy for Knee OA
n=161 Participants
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
91 participants
n=5 Participants
|
93 participants
n=7 Participants
|
184 participants
n=5 Participants
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
|
44.2 units on a scale
STANDARD_DEVIATION 14.9 • n=5 Participants
|
43.3 units on a scale
STANDARD_DEVIATION 14.5 • n=7 Participants
|
43.7 units on a scale
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Short Performance Physical Battery (SPPB)
|
9.2 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12-weeks, 24-weeksPopulation: All enrolled, randomized participants
WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms. Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics.
Outcome measures
| Measure |
Arm 1
n=159 Participants
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Arm 2
n=161 Participants
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
|---|---|---|
|
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Common Baseline Mean
|
43.7 units on a scale
Interval 42.0 to 45.4
|
43.7 units on a scale
Interval 42.0 to 45.4
|
|
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
12 Weeks
|
36.5 units on a scale
Interval 33.9 to 39.1
|
39.1 units on a scale
Interval 36.6 to 41.7
|
|
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
24 Weeks
|
39.3 units on a scale
Interval 36.6 to 42.0
|
40.6 units on a scale
Interval 38.0 to 43.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All enrolled, randomized participants
This battery of objective physical function tests examines participants' balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function. Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics.
Outcome measures
| Measure |
Arm 1
n=159 Participants
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Arm 2
n=161 Participants
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
|---|---|---|
|
Short Performance Physical Battery (SPPB)
Common Baseline Mean
|
9.07 units on a scale
Interval 8.85 to 9.29
|
9.07 units on a scale
Interval 8.85 to 9.29
|
|
Short Performance Physical Battery (SPPB)
12-week follow-up
|
9.15 units on a scale
Interval 8.86 to 9.44
|
9.26 units on a scale
Interval 8.97 to 9.55
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=159 participants at risk
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Arm 2
n=161 participants at risk
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
|---|---|---|
|
Renal and urinary disorders
Hospital Admission
|
0.63%
1/159 • Number of events 2 • Adverse event data were collected during each participant's study period, which was six months.
|
0.00%
0/161 • Adverse event data were collected during each participant's study period, which was six months.
|
Other adverse events
| Measure |
Arm 1
n=159 participants at risk
Group Physical Therapy for Knee OA
Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program.
|
Arm 2
n=161 participants at risk
Individual Physical Therapy for Knee OA
Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Emergency Room Visit
|
1.9%
3/159 • Number of events 3 • Adverse event data were collected during each participant's study period, which was six months.
|
3.1%
5/161 • Number of events 5 • Adverse event data were collected during each participant's study period, which was six months.
|
|
Ear and labyrinth disorders
Emergency Room Visit
|
0.63%
1/159 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
0.00%
0/161 • Adverse event data were collected during each participant's study period, which was six months.
|
|
Investigations
Emergency Room Visit
|
0.63%
1/159 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
0.00%
0/161 • Adverse event data were collected during each participant's study period, which was six months.
|
|
General disorders
Emergency Room Visit
|
0.63%
1/159 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
0.00%
0/161 • Adverse event data were collected during each participant's study period, which was six months.
|
|
Musculoskeletal and connective tissue disorders
Other event
|
0.63%
1/159 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
0.62%
1/161 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
|
Surgical and medical procedures
Outpatient Surgery
|
0.63%
1/159 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
0.00%
0/161 • Adverse event data were collected during each participant's study period, which was six months.
|
|
Skin and subcutaneous tissue disorders
Emergency Room Visit
|
0.00%
0/159 • Adverse event data were collected during each participant's study period, which was six months.
|
0.62%
1/161 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
|
Renal and urinary disorders
Emergency Room Visit
|
0.00%
0/159 • Adverse event data were collected during each participant's study period, which was six months.
|
0.62%
1/161 • Number of events 1 • Adverse event data were collected during each participant's study period, which was six months.
|
Additional Information
Kelli D. Allen
Health Services Research & Development, Durham VAMC
Phone: 919-286-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place