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Research project: SARAH – Strengthening and stretching for people with rheumatoid arthritis of the hand. The clinical and cost effectiveness of an exercise programme over and above usual care

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The SARAH trial is looking at two approaches to treatment for Rheumatoid Arthritis (RA) affecting the hands. We are comparing the provision of joint protection advice with joint protection advice in addition to an exercise programme for the hands and arms. All people who enter the trial will receive joint protection advice, with half of all people in the study also undertaking the exercise programme. Approximately 480 adults will be recruited from across the country.  

What are the treatment options?

Patients will be randomised to one of the following options:

  • An advice session, covering methods to protect joints during every day function. They will attend for a maximum of 3 sessions with a specially trained physiotherapist or occupational therapist who will advise and discuss on how best to protect hand joints, day to day.
  • An advice session on joint protection, identical to the above, followed by a further five sessions of supervised exercise. These sessions will be spread over 12 weeks and will encourage patients to strengthen and stretch their hands and wrists. A specially trained physiotherapist or occupational therapist will provide treatments, and advise on how best to manage their condition. The exercise sessions will last approximately 30 minutes and be on a one to one basis with a therapist.

As well as attending for the allocated treatment patients will be asked to attend for three assessments and asked to fill in some questionnaires about their condition and how it has affected them. Patients will attend for an assessment of their hand and arm function before they receive treatment and again at four and twelve months after joining the study. Assessments will measure hand and arm strength, flexibility and dexterity.

What is the procedure that is being tested?

We are testing the effectiveness of gently stretching the hand joints and strengthening the hand muscles on the painful and disabling effects of RA.

Whilst all participants will be advised on how to protect their joints in every day life we are investigating whether it is possible to improve hand strength, mobility and function.

What are the alternative treatments?

The alternative to exercise is often to rest the hands although we do not know if this is the correct advice. Traditionally, the treatment of RA of the hands has either involved encouraging exercise or not encouraging it. Whilst there is some evidence that exercise is beneficial, not all people with RA of the hands are encouraged to exercise.

What are the possible disadvantages of taking part?

Occasionally people experience a short-term increase in pain after beginning an exercise programme. This is a normal response to treatment and is not usually long lasting.

Who is organising and funding the research?

Professor Sallie Lamb is responsible for the research. It is being funded by the National Health Service’s Health Technology Assessment Programme.

Design: A multi-centre randomized controlled trial with two arms. It will be impossible to blind the treating therapists and thus the study will undertake blinded outcome assessment and analysis.

Setting: Outpatient Rheumatology and Hand Therapy units in Secondary care and Primary care, where available, at 10 recruitment sites across England, grouped into 4 hubs Coventry, Wrightington, London and, Southampton.

Target Population: Patients with RA of the hands and or wrists (American College of Rheumatology criteria) who have an established disease modifying medication regime for 3 months and are not awaiting orthopaedic surgery of the upper limb. Other exclusions are upper limb joint surgery in the previous six months and pregnancy.

Health Technologies Being Assessed: A programme of functional exercise using functional exercises to stretch and strengthen the muscles and mobilise the joints of the hand and wrists, in addition to usual joint protection care (advice and functional splinting) the comparator arm of the trial. Mobility and strength of the hand are important, modifiable factors in hand function and have been shown to be improved with exercise (refs 1&2). As hand function is associated with the ability to position the hand in space, the exercise programme will also exercise the upper limbs. The programme will entail six half-hour appointments spread over three months. This number of contacts will allow adequate progression of the intensity of exercise. Adherence with daily home exercise will be encouraged with behavioural models (ref 3). The exercise programme will also include usual care intervention of standard joint protection advice and functional splinting.

Measurement of Costs and Outcomes: Primary outcome - Arthritis Impact Measurement Scale, AIMS2 - Hand and finger and upper limb function scales - reliable and valid measures, used recently in similar trials (ref 4). Secondary outcomes - The Michigan Hand Outcomes Questionnaire (MHQ) (ref 5). Medication data will be collected systematically from Primary and Secondary Care prescription records and by patient self report. We will collect heath utility data using the EQ5D to calculate QALYs and cost data from participant completed questionnaires. These will collect service use data (primary and secondary care, use of prescribed medication, and private health & social care cost). Unit costs of health care will be calculated from routine data sources e.g HRG costs or actual costs as appropriate. We will conduct a cost utility analysis from both and NHS and a societal perspective. In addition, data will be collected on dexterity, pinch and grip strength, important indices of hand function (ref 2) along with the joint alignment and motion score (ref 6) in order to monitor any deformity development or progression.

Finally, adherence to the exercise advice and self efficacy will be monitored by self report questionnaires (ref 7). Clinical assessments will at baseline, three and twelve months; questionnaire data will be collected at three, six nine & twelve months. The relative occurrence of surgical events will be of particular interest. Qualitative interviews will be undertaken, with a purposively sample of 10 participants, to explore patient expectations and to optimize the intervention package during piloting.

Sample Size: Up to 340 patients. Using the AIMS2 hand and finger function scale, based on earlier work we expect to demonstrate a minimum clinically important difference, between groups, of 0.55 points representing an effect size of 0.30. This estimate is assumes a SD of 1.81 using 80% power, an alpha of 0.05 and a loss to follow up at 12 months of 25%. Each of the 10 recruitment sites will recruit 50 patients over 15 months.

Project team

Jo Adams, J Burridge

External

Sallie Lamb Warwick University
Martin Underwood
Christopher McConkey
Christopher Brindle
Mark Williams
Mrs Anne O’Brien
Mrs Anne Birch
Dr Chris Edwards
Professor Anisur Rahman

Project funder

National Institute for Health Research (Health Technologies Assessment)

Associated research themes

Musculoskeletal rehabilitation
Rheumatology
Hand therapy

Related research groups

Active Living and Rehabilitation
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