Abstract
BACKGROUND: Patients with knee osteoarthritis (OA) report knee pain, limitation in physical activities and low quality of life. The two primary treatments for knee OA are non-surgical treatment (e.g., exercise) and surgery (total knee arthroplasty (TKA)); however, national guidelines recommend non-surgical treatment to be tried prior to surgical procedures. Patients with knee OA are characterized by decreased muscle strength, particularly in the knee-extensor muscles. Correspondingly, decreased knee-extensor strength is found to be associated with an increased risk of development, progression and severity of knee OA symptoms. Recent trials suggest a positive effect of pre-operative exercise on pre- and post-operative outcome; however, the most effective pre-operative knee-extensor strength exercise dosage is not known. The purpose of the present trial is to investigate the efficacy of three different exercise dosages of pre-operative, home-based, knee-extensor strength exercise on knee-extensor strength before and shortly after surgery in patients eligible for TKA due to end-stage knee OA. METHODS: In this randomized dose-response trial with a three-arm parallel design, 140 patients with end-stage knee OA (candidates for TKA) are randomized to one of three exercise dosages (two, four or six session/week) of knee-extensor strength exercise (three sets, 12 repetitions at 12 RM, per exercise session) for 12 weeks. The knee-extensor strength exercise is home-based (unsupervised) and performed with an elastic exercise band following an initial exercise instruction. Adherence is objectively quantified using a sensor attached to the exercise band. The primary outcome will be the change in knee-extensor strength. Following the 12-week exercise period, the need for TKA surgery is re-assessed by an orthopedic surgeon. DISCUSSION: Decreased knee-extensor strength is a major challenge in patients with knee OA. Exercise programs focusing on knee-extensor strength are found to be more effective in relieving knee OA pain and symptoms compared to more general exercise programs. However, the optimal exercise dosage for knee-extensor strength deficits in patients with knee OA is inconclusive. Knowledge on the dose-response relationship for knee-extensor strength exercise in patients with knee OA will help guide future non-surgical treatment in this patient population. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02931058 . Pre-registered on 10 October 2016.