Condition category
Musculoskeletal Diseases
Date applied
11/01/2008
Date assigned
13/02/2008
Last edited
11/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Sarah Lamb

ORCID ID

Contact details

Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 574658
s.lamb@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/32/05

Study information

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

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

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/073205
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/51770/PRO-07-32-05.pdf

On 26/06/2008 the public title was changed from "SARAH: Strengthening in Rheumatoid Arthritis of the Hand" to the current title.

On 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.

Ethics approval

Oxfordshire Research Ethics Committee C, 10/06/2008, ref: 08/H060/47

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2008

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

480

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

United Kingdom

Trial participating centre

Warwick Clinical Trials Unit
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

University House
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22507362
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23176133
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25308290
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25748549

Publication citations

  1. Protocol

    Heine PJ, Williams MA, Williamson E, Bridle C, Adams J, O'Brien A, Evans D, Lamb SE, , Development and delivery of an exercise intervention for rheumatoid arthritis: strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial., Physiotherapy, 2012, 98, 2, 121-130, doi: 10.1016/j.physio.2011.03.001.

  2. Protocol

    , Adams J, Bridle C, Dosanjh S, Heine P, Lamb SE, Lord J, McConkey C, Nichols V, Toye F, Underwood MR, Williams MA, Williamson EM, Strengthening and stretching for rheumatoid arthritis of the hand (SARAH): design of a randomised controlled trial of a hand and upper limb exercise intervention--ISRCTN89936343., BMC Musculoskelet Disord, 2012, 13, 230, doi: 10.1186/1471-2474-13-230.

  3. Results

    Lamb SE, Williamson EM, Heine PJ, Adams J, Dosanjh S, Dritsaki M, Glover MJ, Lord J, McConkey C, Nichols V, Rahman A, Underwood M, Williams MA, , Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial., Lancet, 2014, doi: 10.1016/S0140-6736(14)60998-3.

  4. Results

    Williams MA, Williamson EM, Heine PJ, Nichols V, Glover MJ, Dritsaki M, Adams J, Dosanjh S, Underwood M, Rahman A, McConkey C, Lord J, Lamb SE, Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation, Health Technol Assess, 2015, 19, 19, 1-222, doi: 10.3310/hta19190.

Additional files

Editorial Notes