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Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial

Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial
Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial
Background

Disease-modifying biological agents and other drug regimens have substantially improved control of disease activity and joint damage in people with rheumatoid arthritis of the hand. However, commensurate changes in function and quality of life are not always noted. Tailored hand exercises might provide additional improvements, but evidence is lacking. We estimated the effectiveness and cost-effectiveness of tailored hand exercises in addition to usual care during 12 months.

Methods

In this pragmatic, multicentre, parallel-group trial, at 17 National Health Service sites across the UK we randomly assigned 490 adults with rheumatoid arthritis who had pain and dysfunction of the hands and had been on a stable drug regimen for at least 3 months, to either usual care or usual care plus a tailored strengthening and stretching hand exercise programme. Participants were randomly assigned with stratification by centre. Allocation was computer generated and unmasked to participants and therapists delivering treatment after randomisation. Outcome assessors and all investigators were masked to allocation. Physiotherapists or occupational therapists gave the treatments. The primary outcome was the Michigan Hand Outcomes Questionnaire overall hand function score at 12 months. The analysis was by intention to treat. We calculated cost per quality-adjusted life-year. This trial is registered as ISRCTN 89936343.

Findings

Between Oct 5, 2009, and May 10, 2011, we screened 1606 people, of whom 490 were randomly assigned to usual care (n=244) or tailored exercises (n=246). 438 of 490 participants (89%) provided 12 month follow-up data. Improvements in overall hand function were 3·6 points (95% CI 1·5—5·7) in the usual care group and 7·9 points (6·0—9·9) in the exercise group (mean difference between groups 4·3, 95% CI 1·5—7·1; p=0·0028). Pain, drug regimens, and health-care resource use were stable for 12 months, with no difference between the groups. No serious adverse events associated with the treatment were recorded. The cost of tailored hand exercise was £156 per person; cost per quality-adjusted life-year was £9549 with the EQ-5D (£17 941 with imputation for missing data).

Interpretation

We have shown that a tailored hand exercise programme is a worthwhile, low-cost intervention to provide as an adjunct to various drug regimens. Maximisation of the benefits of biological and DMARD regimens in terms of function, disability, and health-related quality of life should be an important treatment aim.

Funding

UK National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 07/32/05.
0140-6736
421-429
Lamb, Sarah
ab6c6075-2b9e-4341-8343-491290a3d33e
Williamson, Esther
8adb517c-ddbc-4474-ab04-2e6108d856a5
Heine, Peter
53141b60-a5d8-4280-8905-3737689f9a22
Adams, Jo
6e38b8bb-9467-4585-86e4-14062b02bcba
Dosanjh, Sukhdeep
3161ed3c-4d89-48a4-9447-7561b2d4398c
Dritsake, Melinda
a6241078-8026-4d84-b538-62e37542acc8
Glover, Matthew
2fc20d71-01a2-4097-ba03-ee006681e767
Lord, Joanne
fd3b2bf0-9403-466a-8184-9303bdc80a9a
McConkey, Christopher
d78e637f-895c-4986-ad37-fc4bca23cece
Nichols, Vivien
6c36990d-9400-438f-906c-f41e112b185d
Rahman, Anisur
cb88abd6-00b3-44da-87bf-a7772844dc86
Underwood, Martin
239a8609-e7b5-4acb-aaf9-9e7f717f0d62
Williams, Mark
1d702937-6b71-4078-9027-281ad88a6d10
Lamb, Sarah
ab6c6075-2b9e-4341-8343-491290a3d33e
Williamson, Esther
8adb517c-ddbc-4474-ab04-2e6108d856a5
Heine, Peter
53141b60-a5d8-4280-8905-3737689f9a22
Adams, Jo
6e38b8bb-9467-4585-86e4-14062b02bcba
Dosanjh, Sukhdeep
3161ed3c-4d89-48a4-9447-7561b2d4398c
Dritsake, Melinda
a6241078-8026-4d84-b538-62e37542acc8
Glover, Matthew
2fc20d71-01a2-4097-ba03-ee006681e767
Lord, Joanne
fd3b2bf0-9403-466a-8184-9303bdc80a9a
McConkey, Christopher
d78e637f-895c-4986-ad37-fc4bca23cece
Nichols, Vivien
6c36990d-9400-438f-906c-f41e112b185d
Rahman, Anisur
cb88abd6-00b3-44da-87bf-a7772844dc86
Underwood, Martin
239a8609-e7b5-4acb-aaf9-9e7f717f0d62
Williams, Mark
1d702937-6b71-4078-9027-281ad88a6d10

Lamb, Sarah, Williamson, Esther, Heine, Peter, Adams, Jo, Dosanjh, Sukhdeep, Dritsake, Melinda, Glover, Matthew, Lord, Joanne, McConkey, Christopher, Nichols, Vivien, Rahman, Anisur, Underwood, Martin and Williams, Mark (2015) Exercises to improve function of the rheumatoid hand (SARAH): a randomised controlled trial. The Lancet, 385 (9966), 421-429. (doi:10.1016/S0140-6736(14)60998-3).

Record type: Article

Abstract

Background

Disease-modifying biological agents and other drug regimens have substantially improved control of disease activity and joint damage in people with rheumatoid arthritis of the hand. However, commensurate changes in function and quality of life are not always noted. Tailored hand exercises might provide additional improvements, but evidence is lacking. We estimated the effectiveness and cost-effectiveness of tailored hand exercises in addition to usual care during 12 months.

Methods

In this pragmatic, multicentre, parallel-group trial, at 17 National Health Service sites across the UK we randomly assigned 490 adults with rheumatoid arthritis who had pain and dysfunction of the hands and had been on a stable drug regimen for at least 3 months, to either usual care or usual care plus a tailored strengthening and stretching hand exercise programme. Participants were randomly assigned with stratification by centre. Allocation was computer generated and unmasked to participants and therapists delivering treatment after randomisation. Outcome assessors and all investigators were masked to allocation. Physiotherapists or occupational therapists gave the treatments. The primary outcome was the Michigan Hand Outcomes Questionnaire overall hand function score at 12 months. The analysis was by intention to treat. We calculated cost per quality-adjusted life-year. This trial is registered as ISRCTN 89936343.

Findings

Between Oct 5, 2009, and May 10, 2011, we screened 1606 people, of whom 490 were randomly assigned to usual care (n=244) or tailored exercises (n=246). 438 of 490 participants (89%) provided 12 month follow-up data. Improvements in overall hand function were 3·6 points (95% CI 1·5—5·7) in the usual care group and 7·9 points (6·0—9·9) in the exercise group (mean difference between groups 4·3, 95% CI 1·5—7·1; p=0·0028). Pain, drug regimens, and health-care resource use were stable for 12 months, with no difference between the groups. No serious adverse events associated with the treatment were recorded. The cost of tailored hand exercise was £156 per person; cost per quality-adjusted life-year was £9549 with the EQ-5D (£17 941 with imputation for missing data).

Interpretation

We have shown that a tailored hand exercise programme is a worthwhile, low-cost intervention to provide as an adjunct to various drug regimens. Maximisation of the benefits of biological and DMARD regimens in terms of function, disability, and health-related quality of life should be an important treatment aim.

Funding

UK National Institute of Health Research Health Technology Assessment Programme (NIHR HTA), project number 07/32/05.

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More information

Accepted/In Press date: 2014
e-pub ahead of print date: 9 October 2014
Published date: 31 January 2015
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 367518
URI: http://eprints.soton.ac.uk/id/eprint/367518
ISSN: 0140-6736
PURE UUID: b0f16938-69c5-4593-9866-0cb4187262f2
ORCID for Jo Adams: ORCID iD orcid.org/0000-0003-1765-7060
ORCID for Joanne Lord: ORCID iD orcid.org/0000-0003-1086-1624

Catalogue record

Date deposited: 05 Sep 2014 13:22
Last modified: 15 Mar 2024 03:52

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Contributors

Author: Sarah Lamb
Author: Esther Williamson
Author: Peter Heine
Author: Jo Adams ORCID iD
Author: Sukhdeep Dosanjh
Author: Melinda Dritsake
Author: Matthew Glover
Author: Joanne Lord ORCID iD
Author: Christopher McConkey
Author: Vivien Nichols
Author: Anisur Rahman
Author: Martin Underwood
Author: Mark Williams

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