N/A
N=92
Optimizing Physical Activity Outcomes After Total Knee Arthroplasty
Total Knee Arthroplasty · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03226106 ↗Enrolled (actual)
92
Serious AEs
12.0%
Results posted
Oct 2024
Primary outcome: Primary: Free-living Daily Step Count — 6947; 6339 step count — p=0.024
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Activity Behavior Intervention (Behavioral); Attention Control (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Free-living Daily Step Count |
6947; 6339 | 0.024 sig |
| SECONDARY 30-Second Chair-Stand Test W14 |
13; 12 | 0.584 |
| SECONDARY 30-Second Chair-Stand Test W38 |
14; 14 | 0.724 |
| SECONDARY Six-Minute Walk Test W14 |
433; 434 | 0.547 |
| SECONDARY Six-Minute Walk Test W38 |
452; 451 | 0.716 |
| SECONDARY Timed Up-and-Go Test W14 |
9.8; 9.4 | 0.946 |
| SECONDARY Timed Up-and-Go Test W38 |
9.1; 9.0 | 0.906 |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index W14 |
18; 21 | 0.873 |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index W38 |
13; 22 | 0.241 |
| SECONDARY Veterans RAND 12-Item Health Survey Physical Component W14 |
43; 39 | 0.223 |
| SECONDARY Veterans RAND 12-Item Health Survey Physical Component W38 |
43; 41 | 0.388 |
| SECONDARY Veterans RAND 12-Item Health Survey Mental Component W14 |
54; 52 | 0.88 |
| SECONDARY Veterans RAND 12-Item Health Survey Mental Component W38 |
55; 51 | 0.85 |
| SECONDARY Free-living Daily Step Count W38 |
7287; 6855 | 0.101 |
Summary
Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.
Eligibility Criteria
Inclusion Criteria
- Veteran
- Planned unilateral total knee arthroplasty
Exclusion Criteria
- Severe non-surgical limb pain (pain >5/10 on non-surgical limb with walking)
- Unstable orthopedic, neurologic, or pulmonary condition that limits function
- Unstable cardiac condition
- Uncontrolled hypertension
- Uncontrolled diabetes
- Acute systemic infection
- Active cancer treatment
- Recent stroke (within 2 years)
Data sourced from ClinicalTrials.gov (NCT03226106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.