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| SARAH: Strengthening in Rheumatoid Arthritis of the Hand |
| Source of record | UK Trials |
| ISRCTN | ISRCTN89936343 |
| Date ISRCTN assigned | 13/02/2008 |
| Local reference number(s) | HTA 07/32/05 |
| Public title | SARAH: Strengthening in Rheumatoid Arthritis of the Hand |
| Scientific title | SARAH: Strengthening and stretching for people with rheumatoid arthritis of the hands: The clinical and cost effectiveness of an exercise programme over and above usual care |
| Acronym | SARAH |
| Disease/condition/study domain | Rheumatoid arthritis affecting the hands and wrists |
| Study hypothesis | 1. To estimate the clinical effectiveness of adding an optimised exercise programme for hands and upper limbs in addition to standard care, joint protection, in the reduction of hand dysfunction and pain for patients with rheumatoid arthritis 2. To estimate the cost-effectiveness of adding this programme to usual care 3. To describe, qualitatively, the experience on participants in the trial with a particular emphasis on patient expectation, exercise behaviours, and reasons for adherence/non-adherence |
| Design/methodology | Pragmatic randomised controlled trial |
| Research ethics review | Multi-centre Research Ethics Committee (MREC), application in process. Submission expected in February 2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. People with RA 2. Those who meet the American College of Rheumatology clinical and immunological criteria, with pain and dysfunction of the hands and or wrist joints 3. Either not on a Disease-Modifying Anti-Rheumatic Drugs (DMARD), or who have been on a stable DMARD regimen, for three months or more |
| Participants - exclusion criteria | 1. Patients recovering from upper limb joint surgery, or fracture, in the previous six months 2. Patients on a waiting list for upper limb orthopaedic surgery 3. Patients who are pregnant 4. Aged less than 18 years |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 31/03/2012 |
| Status of trial | Ongoing |
| Target number of participants | 480 |
| Interventions | Participants will be randomly allocated to the intervention and control groups. Intervention group: Standard care (joint protection advice and functional splinting) supplemented with an optimised exercise programme In addition to the participants receiving conventional care we are proposing to implement a programme of exercise therapy to increase hand function using functional exercises to stretch and strengthen the muscles and tendons, also to mobilise the joints of the hand and wrist and improve dexterity. The programme will entail six half-hour appointments spread over 12 weeks. This number of contacts, spread over this epoch, will allow sufficient progression of the intensity of exercise and physiological response in the neuromuscular system to significantly improve function. The exercise programme was developed following a professional consensus of UK physiotherapists/occupational therapists and has some evidence of short-term effectiveness. We are proposing a number of additional elements designed to increase long-term effectiveness. The intervention will use a standardised protocol of progression and reduction of exercise intensity. 1. Specific Functional Exercise: Our exercise programme will use sound exercise principles to improve strength, mobility and dexterity whilst performing functional tasks. 2. Progressive Resistance Training: Participants will be provided with elastic resistance bands (Theratube, Akron, USA) that provide this resistance and can progressively increase demand. 3. Mobility Exercise: The tendon sheaths of patients with RA hands are known to suffer from adhesions and consequently specific 'tendon sliding' exercises have been developed that target movements of the wrist and fingers in combination to maintain full mobility of the flexor and extensor tendons and will be incorporated into the programme. People with hand RA frequently have deformity of the hands and wrists that make the placement of their hands into positions for efficient function difficult. Additionally, people with RA can develop restriction of movement of the elbows and shoulders as well as the hands. Thus, as the function of the hand is associated with the ability to position and maintain the hand in space, the exercise programme will also include mobility exercise of all the upper limbs joints. 4. Dexterity Exercise: Functional tasks demanding increasing dexterity will be introduced in stages and the performance of tasks timed and critiqued. 5. Home Exercise: The number of home exercises and the demand of dexterity tasks will be progressively increased to ensure the intensity of home exercise is adequate to overload the muscular system and challenge sensori-motor control. Targets for home exercise will be based on individual assessment of performance and progressed at four, eight and twelve weeks. 6. Adherence with Home Exercise: We aim to maximise adherence to the prescribed exercise regimen through a two-stage mechanism that distinguishes between motivational and volitional phases of behaviour. The programme will entail six half-hour appointments spread over 12 weeks. Exercise will be provided individually by a physiotherapist. Control group: Standard care only |
| Primary outcome measure(s) | The Arthritis Impact Measurement Scales (AIMS) 2, Finger and Hand function subscale at 0, 3 and 12 months. |
| Secondary outcome measure(s) | 1. AIMS 2 Upper Limb function subscale at 0, 3 and 12 months 2. AIMS 2 Arthritis Pain Scale at 0, 3 and 12 months 3. Grip and pinch strength at 0, 3 and 12 months 4. Dexterity at 0, 3 and 12 months 5. Range of motion at 0, 3 and 12 months 6. Joint alignment at 0, 3 and 12 months 7. Joint tenderness and swelling at 0, 3 and 12 months 8. Disease activity at 0, 3 and 12 months 9. EuroQol EQ-5D at 0, 3 and 12 months 10. Adapted Michigan Hand Outcomes Questionnaire at 3 and 12 months 11. Global change question 7 point Likert scale at 3 and 12 months 12. Resource use questionnaire at 0, 3 and 12 months 13. EuroQol EQ-5D: Health Utility at 0, 3 and 12 months |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Warwick (UK) |
| Sponsor details | University House Coventry United Kingdom CV4 7AL |
| Sponsor website | http://www2.warwick.ac.uk |
| Contact name | Dr Christopher McCarthy |
| Contact details | Warwick Clinical Trials Unit Warwick Medical School Gibbett Hill Coventry United Kingdom CV4 7AL |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN89936343 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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