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Does Rehabilitation After Total Knee Arthroplasty Work? - Feasibility Trial (DRAW-TKA-Fea)
The aim of this feasibility trial is to investigate the feasibility of a trial intervention for a population of patients after total knee replacement for osteoarthritis. This study follows a hybrid type 1 design where the primary focus is on the feasibility of the intervention, and the secondary focus is on gaining a better understanding of context and acceptability. The main questions it aims to answer are: * Recruitment (Process/Resources): Are patients willing to engage, and stay, in the trial (estimated by inclusion-rate, participant retention, etc.) and what reasons do patients give for not wishing to enroll or later dropping out of the trial? (inquired face-to-face, during enrolment). * Harms (Scientific): Does the non-exercise intervention appear "safe" (i.e. not harmful) for the patients? (estimated by for instance: adverse events, reasons for dropouts and sense of security). * Trial procedure feasibility (Management/Scientific): How well does recruitment and trial procedures work at trial sites? (estimated through feedback from site personnel). * Participant (patient) experienced acceptability of their assigned intervention: An interview-based follow-up using the Theoretical Framework of Acceptability. Participants will be randomized to one of two interventions, at discharge from the hospital, following knee replacement, which are being tested for feasibility: 1. "Usual-care" - referral to municipal (free-of-charge) physiotherapy (commonly 6-8 weeks of therapeutic exercise). 2. "Return to everyday life" - no referral to municipal physiotherapy. Participants in both groups are encouraged to follow WHO guidelines of physical activity, to the degree that their post-surgical symptoms allow (within their orthopedic surgeon's recommendations/limitations). All participants are given a "symptom guide", meaning a folder containing information on what to expect, and when and what to react to, during their recovery after the knee-replacement. For clarity it should be mentioned, that the quantitative and qualitative data-outputs will be reported separately for improved clarity (the study is not a mixed methods design).
Details
| Lead sponsor | Copenhagen University Hospital, Hvidovre |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | Tue Aug 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Sep 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Osteoarthritis, Knee
Interventions
- Usual care - Municipal exercise-based rehabilitation
- Return to Everyday life
- Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity
Countries
Denmark