SARAH: Stretching and Strengthening for Rheumatoid Arthritis of the Hand
| ISRCTN | ISRCTN89936343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89936343 |
| Secondary identifying numbers | HTA 07/32/05 |
- Submission date
- 11/01/2008
- Registration date
- 13/02/2008
- Last edited
- 18/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
http://www2.warwick.ac.uk/fac/med/research/ctu/trials/ecr/sarah
Contact information
Prof Sarah Lamb
Scientific
Scientific
Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)2476 574658 |
|---|---|
| s.lamb@warwick.ac.uk |
Study information
| Study design | Pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | SARAH: Stretching and Strengthening for Rheumatoid Arthritis of the Hand: the clinical and cost effectiveness of an exercise programme over and above usual care |
| Study acronym | SARAH |
| 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 |
| Ethics approval(s) | Oxfordshire Research Ethics Committee C, 10/06/2008, ref: 08/H060/47 |
| Condition | Rheumatoid arthritis affecting the hands and wrists |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 18/08/2011: The Michigan Hand Outcomes Questionnaire (MHQ) Overall hand function score over 12 months Previous primary outcome measure: The Arthritis Impact Measurement Scales (AIMS) 2, Finger and Hand function subscale at 0, 3 and 12 months. |
| Secondary outcome measures | Current secondary outcome measures as of 14/08/2009: 1. Michigan Hand Outcomes Questionnaire (MHQ) at 0, 4 and 12 months 2. MHQ pain subscale and Pain 'Troublesomeness' at 0, 4 and 12 months 3. Grip and pinch strength at 0, 4 and 12 months 4. Dexterity at 0, 4 and 12 months 5. Hand and wrist Range of motion at 0, 4 and 12 months 6. MCPJ Joint alignment at 0, 4 and 12 months 7. Joint tenderness and swelling at 0, 4 and 12 months 8. Disease activity at 0, 4 and 12 months 9. SF-12 at 0, 4 and 12 months 10. Self-efficacy at 0, 4 and 12 months 11. Treatment satisfaction at 4 and 12 months 12. Global change question 7 point Likert scale at 4 and 12 months 13. Adherence to home exercise questionnaire at 0, 4 and 12 months 14. Resource use questionnaire at 0, 4 and 12 months 15. EuroQol EQ-5D: Health Utility at 0, 4 and 12 months The above changes are in line with protocol V2 14/08/2009 Previous secondary outcome measures: 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 The following secondary outcome measure was added as of 10/07/2008: 14. Adherence to home exercise, assessed at 3 and 12 months |
| Overall study start date | 01/11/2008 |
| Overall study end date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 480 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/11/2008 |
| Recruitment end date | 30/04/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
University House
Coventry
CV4 7AL
England
United Kingdom
| Website | http://www2.warwick.ac.uk |
|---|---|
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2012 | Yes | No | |
| Protocol article | protocol | 24/11/2012 | Yes | No | |
| Results article | results | 31/01/2015 | Yes | No | |
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 12/04/2017 | Yes | No |
Editorial Notes
18/04/2017: Publication reference added.
21/08/2009: The overall trial start and end dates were changed from 01/09/2008 and 31/03/2012 to 01/11/2008 and 30/04/2012, respectively.
26/06/2008: The public title was changed from "SARAH: Strengthening in Rheumatoid Arthritis of the Hand" to the current title.
