Development and delivery of an exercise intervention for rheumatoid arthritis: Strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial

Abstract

This paper describes the development and implementation of a hand exercise intervention for rheumatoid arthritis (RA) as part of a large multi-centred randomised controlled trial in a UK National Health Service (NHS) setting. Participants are eligible if diagnosed with RA according to American College of Rheumatology criteria, have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. The intervention development was informed by the current evidence base, published guidelines, clinician and expert opinion, and a pilot study. The exercise programme targets known, potentially modifiable physical impairments of the hand with 5 exercise sessions and a home exercise component over a 12 week period. The intervention will be provided to 240 participants along with usual care. A further 240 will receive usual care only as part of the control arm. Specific details of the treatments delivered are described. [ISRCTN no: 89936343].

Introduction

There is evidence suggesting that exercise improves general muscular endurance and strength without detrimental effects on disease activity or pain in rheumatoid arthritis [1]. However, few studies have investigated the effect of exercises for the rheumatoid hand. Some improvement in strength, mobility and/or function with no negative effects have been reported [2], [3], [4], [5], [6], [7], although the long term effectiveness has not been established due to various weaknesses in trial design.

In 2007, the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme commissioned a large-scale pragmatic randomised controlled trial to investigate the clinical and cost-effectiveness of an exercise programme for the management of rheumatoid arthritis of the hand. A trial of any complex intervention should include a description of the intervention and its components as an essential step of reporting [8]. Therefore, the purpose of this paper is to describe the experimental intervention used in the SARAH trial, as well as the rationale for the intervention design.

We have designed and initiated recruitment to a trial [Strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial, ISRCTN no: 89936343] testing an exercise intervention against the usual hand care typically provided in the UK NHS. Participants are eligible if diagnosed with rheumatoid arthritis according to American College of Rheumatology criteria [9], have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. By the end of the trial, 480 patients will have been recruited making it the largest study of hand exercise for rheumatoid arthritis (Fig. 1). Patients will be randomised on a 1:1 ratio into two arms: usual care only (control) or usual care plus exercise (experimental). The main aim of the exercise programme is increased hand function, which is suggested to be mediated by increases in strength, dexterity and range-of-movement [10], [11], [12]. Accordingly, the primary outcome of the trial is self-reported hand function as measured by the Michigan Hand Outcome Questionnaire (MHQ), with secondary outcomes including grip strength, joint range-of-motion and dexterity. Measures will be taken prior to randomisation and at 4 and 12 months after randomisation by blinded assessors.