RecruitingACTRN12609000054213

Effectiveness and cost-effectiveness of a novel rehabilitation strategy in people undergoing primary total knee replacement surgery. The MARKER (Maximum Recovery After Knee Replacement Surgery) Study.


Sponsor

Dr Marlene Fransen

Enrollment

600 participants

Start Date

Jun 1, 2009

Study Type

Interventional

Conditions

Summary

There is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR) immediately after discharge from the orthopaedic ward. It is hypothesised that the demonstrated lack of benefit is due to the low exercise intensity tolerated at this time, with patients still recovering from the effects of major orthopaedic surgery. The aim of this study is to investigate the effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, about six weeks later, by outpatient exercise classes. It is hypothesised that the novel rehabilitation strategy will be more beneficial than the usual practice of providing outpatient rehabilitation immediately following discharge from the orthopaedic ward.


Eligibility

Sex: Both males and femalesMin Age: 45 YearssMax Age: 74 Yearss

Plain Language Summary

Simplified for easier understanding

This study — called the MARKER Study — is comparing two approaches to rehabilitation after total knee replacement surgery. The usual approach starts outpatient physiotherapy sessions right after leaving hospital. This study is testing a new approach: starting with simple exercises at home, then attending outpatient group exercise classes about six weeks later when the body is more ready. Researchers believe waiting until the body has healed more may lead to better long-term outcomes. You may be eligible if: - You are between 45 and 74 years old - You are having a first-time (primary) total knee replacement on one or both knees - You are able to give informed consent - You will be discharged home after surgery You may NOT be eligible if: - You have had a previous partial knee replacement or bone-cutting procedure on the same knee - You had another lower limb joint replacement in the past 6 months - You expect to need another lower limb joint replacement within 12 months - You have a serious health condition that stops you from doing moderate exercise - You have rheumatoid arthritis or a major neurological condition - You cannot travel to one of the study sites for exercise classes Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Novel rehabilitation strategy, consisting of rehabilitation provided in 2 stages. Stage 1: Initial home exercise programme (usually Week 1 to 6 after hospital discharge). The exercises will focus o

Novel rehabilitation strategy, consisting of rehabilitation provided in 2 stages. Stage 1: Initial home exercise programme (usually Week 1 to 6 after hospital discharge). The exercises will focus on maintaining and improving active knee flexion and extension range of motion. Participants will perform 5 to 10 times of 3 to 5 exercises 3 times per day. Participants’ progress, including adherence to the home exercise programme, walking ability and knee symptoms will be monitored weekly by a research physiotherapist, with clinic visits in the first one or two weeks and by telephone calls thereafter. Stage 2: Outpatient exercise classes (usually Week 6 to 14 after hospital discharge) About four weeks after total knee replacement surgery, a research physiotherapist will commence screening during the weekly telephone calls to assess eligibility to commence the classes: (i) surgical wound healed, (ii) full weight-bearing tolerated on the operated limb, (iii) ambulating independently outdoors for more than 50 m, and (iv) not requiring daily opioid-based analgesics for knee pain. The exercise classes will be circuit-based and supervised by a physiotherapist. The one hour classes will be conducted twice a week for eight weeks. Each class will consist of a warm up and cool down component, progressive functional and strengthening exercises, and a 20-minute monitored aerobic exercise session on stationary bicycles. At the beginning of each exercise class, knee pain, range of motion and swelling will be evaluated to allow appropriate exercise progression. Class size will be restricted to a maximum of six participants. Participants will be required to do at least one additional intensive exercise session per week at home, consisting of 30 minutes of walking outdoors or stationary bicycle. In addition, one education class will be provided to participants, focusing on the rationale for increasing lower limb muscle strength and beneficial lifestyle behaviours appropriate after total knee replacement.


Locations(1)

Australia

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ACTRN12609000054213