Trial Outcomes & Findings for A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement (NCT NCT03228719)
NCT ID: NCT03228719
Last Updated: 2025-05-11
Results Overview
Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Baseline, discharge from PT, and 6 months after PT discharge
Results posted on
2025-05-11
Participant Flow
The study protocol enrolled n=125 study participants, however prior to randomization n=5 subjects dropped out of the study. Hence, n=120 study participants were randomized, which is the number stated in the participant flow module.
Participant milestones
| Measure |
Control Group
Standardized Outpatient Physical Therapy after Total Knee Replacement
|
Intervention Group
Standardized Outpatient Physical Therapy after Total Knee Replacement with a Physical Activity Intervention
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
62
|
|
Overall Study
COMPLETED
|
54
|
56
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Intervention
n=55 Participants
Group received Outpatient Physical Therapy Plus a Physical Activity Intervention
|
Control
n=55 Participants
Group received Outpatient Physical Therapy only
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.80 years
STANDARD_DEVIATION 8.65 • n=99 Participants
|
64.70 years
STANDARD_DEVIATION 6.57 • n=107 Participants
|
66.30 years
STANDARD_DEVIATION 7.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=99 Participants
|
55 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Moderate to Vigorous Intensity Physical Activity
|
3.94 Minutes/day
STANDARD_DEVIATION 9.12 • n=99 Participants
|
6.70 Minutes/day
STANDARD_DEVIATION 9.04 • n=107 Participants
|
5.32 Minutes/day
STANDARD_DEVIATION 9.15 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, discharge from PT, and 6 months after PT dischargeTime spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week
Outcome measures
| Measure |
Control
n=55 Participants
Group received Outpatient Physical Therapy only
|
Intervention
n=55 Participants
Group received Outpatient Physical Therapy Plus a Physical Activity Intervention
|
|---|---|---|
|
Physical Activity Measured by an Actigraph GT3X Monitor
Baseline MVPA
|
23.8 Minutes/Week
Interval 11.2 to 36.4
|
9.8 Minutes/Week
Interval 4.2 to 15.4
|
|
Physical Activity Measured by an Actigraph GT3X Monitor
Discharge MVPA
|
86.8 Minutes/Week
Interval 48.3 to 125.3
|
63 Minutes/Week
Interval 35.0 to 91.0
|
|
Physical Activity Measured by an Actigraph GT3X Monitor
6 Months MVPA
|
89.6 Minutes/Week
Interval 31.5 to 147.74
|
55.3 Minutes/Week
Interval 15.4 to 95.2
|
Adverse Events
Control Group
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Intervention Group
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=58 participants at risk
Standardized Outpatient Physical Therapy after TKR
|
Intervention Group
n=62 participants at risk
Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
6.9%
4/58 • Number of events 4 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
8.1%
5/62 • Number of events 5 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Surgical and medical procedures
Surgical Complication
|
1.7%
1/58 • Number of events 1 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
0.00%
0/62 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.7%
1/58 • Number of events 1 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
0.00%
0/62 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Diagnosis
|
1.7%
1/58 • Number of events 1 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
0.00%
0/62 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Surgical and medical procedures
Knee Replacement Revision
|
3.4%
2/58 • Number of events 2 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
0.00%
0/62 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
Other adverse events
| Measure |
Control Group
n=58 participants at risk
Standardized Outpatient Physical Therapy after TKR
|
Intervention Group
n=62 participants at risk
Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention
|
|---|---|---|
|
Vascular disorders
DVT
|
8.6%
5/58 • Number of events 5 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
0.00%
0/62 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
15.5%
9/58 • Number of events 9 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
16.1%
10/62 • Number of events 10 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
37.9%
22/58 • Number of events 22 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
56.5%
35/62 • Number of events 35 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Swelling
|
3.4%
2/58 • Number of events 2 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
12.9%
8/62 • Number of events 8 • Adverse Events were collected from enrollment until the last follow up, i.e., at 12 months after discharge from outpatient physical therapy, up to 16 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place