Feasibility of a randomized trial comparing exercise-based rehabilitation to no exercise-based rehabilitation after
Birk M Grønfeldt1,2,3, Søren T Skou4,5, Jeanette W Kirk1,6
1Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.
Objective:
Trials comparing the effectiveness of exercise-based rehabilitation against no exercise-based rehabilitation are needed, but their feasibility is unclear. The DRAW-TKA feasibility trial aimed to assess recruitment-, retention-, harms-, and procedural feasibility to inform a full-scale effectiveness trial.
Design:
This pragmatic, multicentre, parallel, two-arm feasibility trial included participants scheduled for total knee arthroplasty due to osteoarthritis, aged ≥18, who could read and write Danish. Participants were recruited pre-operatively from two hospitals. At discharge, participants were encouraged to be physically active and randomised (one-to-one) to "Referral to exercise" (usual care) or "No exercise". Recruiters, outcome assessors, and intervention-deliverers were masked to allocation. The primary feasibility criteria were based on recruitment rate, retention, participation barriers, and data completeness. Secondary criteria on harms, procedural feasibility, and intervention acceptance.
Results:
Between Aug 22nd, 2023, and Feb 29th, 2024, all 445 patients planned for TKA were screened, of whom 338 (76 %) were ineligible, 49 of 107 eligible (45·8 %) declined participation (wanted exercise), and 25 of 107 (23·4 %) were randomly assigned exercise (n = 12) or no exercise (n = 13). Because of intervention-specific withdrawals (n = 3) and attrition, 18 of 25 completed all three-month assessments. Three of four predefined, primary feasibility criteria were met. Clinicians and participants found the trial procedurally feasible and acceptable. No interventional harms occurred.
Conclusion:
The trial's scientific rationale - allocation to exercise, or no exercise - introduced significant risk of selection and attrition bias in this clinical context, severely limiting the generalisability. Although recruitment was predominantly feasible, further adaptations are required to warrant full-scale initiation.NCT05935020.
