Development and delivery of an exercise intervention for rheumatoid arthritis: Strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial

Heine, Peter J; Williams, Mark A.; Williamson, Esther; Bridle, Christopher; Adams, Jo; O’Brien, Anne; Evans, David W.; Lamb, Sarah E

doi:10.1016/j.physio.2011.03.001

Cited by 47 publications

(50 citation statements)

References 25 publications

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“…This booklet is widely provided in clinical practice. They will also receive an information sheet about hand exercises, based on the Strengthening And Stretching For Rheumatoid Arthritis of the Hand (SARAH) trial hand exercise programme for RA [19, 20]. During the 12 weeks, participants will only receive brief training in joint protection and hand exercises, and this will not use cognitive-behavioural approaches.…”

Section: Methodsmentioning

confidence: 99%

The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial)

Prior

Sutton²,

Cotterill

et al. 2017

BMC Musculoskelet Disord

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BackgroundArthritis gloves are regularly provided as part of the management of people with rheumatoid arthritis (RA) and undifferentiated (early) inflammatory arthritis (IA). Usually made of nylon and elastane (i.e. Lycra®), these arthritis gloves apply pressure with the aims of relieving hand pain, stiffness and improving hand function. However, a systematic review identified little evidence supporting their use. We therefore designed a trial to compare the effectiveness of the commonest type of arthritis glove provided in the United Kingdom (Isotoner gloves) (intervention) with placebo (control) gloves (i.e. larger arthritis gloves providing similar warmth to the intervention gloves but minimal pressure only) in people with these conditions.MethodsParticipants aged 18 years and over with RA or IA and persistent hand pain will be recruited from National Health Service Trusts in the United Kingdom. Following consent, participants will complete a questionnaire booklet, then be randomly allocated to receive intervention or placebo arthritis gloves. Within three weeks, they will be fitted with the allocated gloves by clinical specialist rheumatology occupational therapists. Twelve weeks (i.e. the primary endpoint) after completing the baseline questionnaire, participants will complete a second questionnaire, including the same measures plus additional questions to explore adherence, benefits and problems with glove-wear. A sub-sample of participants from each group will be interviewed at the end of their participation to explore their views of the gloves received. The clinical effectiveness and cost-effectiveness of the intervention, compared to placebo gloves, will be evaluated over 12 weeks. The primary outcome measure is hand pain during activity. Qualitative interviews will be thematically analysed.DiscussionThis study will evaluate the commonest type of arthritis glove (Isotoner) provided in the NHS (i.e. the intervention) compared to a placebo glove. The results will help occupational therapists, occupational therapy services and people with arthritis make informed choices as to the value of arthritis gloves. If effective, arthritis gloves should become more widely available in the NHS to help people with RA and IA manage hand symptoms and improve performance of daily activities, work and leisure. If not, services can determine whether to cease supplying these to reduce service costs.Trial registrationISRCTN Registry: ISRCTN25892131 Registered 05/09/2016Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-017-1583-4) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial)

Prior

Sutton²,

Cotterill

et al. 2017

BMC Musculoskelet Disord

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“…The rationale and protocol for the interventions are described in a separate paper [32]. All interventions are delivered by PTs or OTs experienced in the treatment of hand and rheumatology conditions.…”

Section: Methodsmentioning

confidence: 99%

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

Adams

Bridle

Dosanjh

et al. 2012

BMC Musculoskelet Disord

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BackgroundRheumatoid Arthritis (RA) commonly affects the hands and wrists with inflammation, deformity, pain, weakness and restricted mobility leading to reduced function. The effectiveness of exercise for RA hands is uncertain, although evidence from small scale studies is promising. The Strengthening And Stretching for Rheumatoid Arthritis of the Hand (SARAH) trial is a pragmatic, multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of adding an optimised exercise programme for hands and upper limbs to best practice usual care for patients with RA.Methods/design480 participants with problematic RA hands will be recruited through 17 NHS trusts. Treatments will be provided by physiotherapists and occupational therapists. Participants will be individually randomised to receive either best practice usual care (joint protection advice, general exercise advice, functional splinting and assistive devices) or best practice usual care supplemented with an individualised exercise programme of strengthening and stretching exercises. The study assessors will be blinded to treatment allocation and will follow participants up at four and 12 months. The primary outcome measure is the Hand function subscale of the Michigan Hand Outcome Questionnaire, and secondary outcomes include hand and wrist impairment measures, quality of life, and resource use. Economic and qualitative studies will also be carried out in parallel.DiscussionThis paper describes the design and development of a trial protocol of a complex intervention study based in therapy out-patient departments. The findings will provide evidence to support or refute the use of an optimised exercise programme for RA of the hand in addition to best practice usual care.Trial registrationCurrent Controlled Trials ISRCTN89936343

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“…For the strength programme, the physiotherapist and the participant together selected an exercise from the designated set(s) that could be performed well and without pain for 10 repetitions (at least 8 and up to a maximum of 12) at a moderate intensity (rating 3-4 Borg RPE scale). 129 The number of sets was progressed up to a maximum of three sets of 10 repetitions, then the exercise level was reviewed (e.g. moving from prone trunk extension with arms to assist to prone trunk extension without arm assistance).…”

Section: Intervention Prescription Progression or Regressionmentioning

confidence: 99%

Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT

Barker

Newman

Stallard

et al. 2019

Health Technol Assess

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Background A total of 25,000 people in the UK have osteoporotic vertebral fracture (OVF). Evidence suggests that physiotherapy may have an important treatment role. Objective The objective was to investigate the clinical effectiveness and cost-effectiveness of two different physiotherapy programmes for people with OVF compared with a single physiotherapy session. Design This was a prospective, adaptive, multicentre, assessor-blinded randomised controlled trial (RCT) with nested qualitative and health economic studies. Setting This trial was based in 21 NHS physiotherapy departments. Participants The participants were people with symptomatic OVF. Interventions Seven sessions of either manual outpatient physiotherapy or exercise outpatient physiotherapy compared with the best practice of a 1-hour single session of physiotherapy (SSPT). Main outcome measures Outcomes were measured at 4 and 12 months. The primary outcomes were quality of life and muscle endurance, which were measured by the disease-specific QUALEFFO-41 (Quality of Life Questionnaire of the European Foundation for Osteoporosis – 41 items) and timed loaded standing (TLS) test, respectively. Secondary outcomes were (1) thoracic kyphosis angle, (2) balance, evaluated via the functional reach test (FRT), and (3) physical function, assessed via the Short Physical Performance Battery (SPPB), 6-minute walk test (6MWT), Physical Activity Scale for the Elderly, a health resource use and falls diary, and the EuroQol-5 Dimensions, five-level version. Results A total of 615 participants were enrolled, with 216, 203 and 196 randomised by a computer-generated program to exercise therapy, manual therapy and a SSPT, respectively. Baseline data were available for 613 participants, 531 (86.6%) of whom were women; the mean age of these participants was 72.14 years (standard deviation 9.09 years). Primary outcome data were obtained for 69% of participants (429/615) at 12 months: 175 in the exercise therapy arm, 181 in the manual therapy arm and 173 in the SSPT arm. Interim analysis met the criteria for all arms to remain in the study. For the primary outcomes at 12 months, there were no significant benefits over SSPT of exercise [QUALEFFO-41, difference –0.23 points, 95% confidence interval (CI) –3.20 to 1.59 points; p = 1.000; and TLS test, difference 5.77 seconds, 95% CI –4.85 to 20.46 seconds; p = 0.437] or of manual therapy (QUALEFFO-41, difference 1.35 points, 95% CI –1.76 to 2.93 points; p = 0.744; TLS test, difference 9.69 seconds (95% CI 0.09 to 24.86 seconds; p = 0.335). At 4 months, there were significant gains for both manual therapy and exercise therapy over SSPT in the TLS test in participants aged < 70 years. Exercise therapy was superior to a SSPT at 4 months in the SPPB, FRT and 6MWT and manual therapy was superior to a SSPT at 4 months in the TLS test and FRT. Neither manual therapy nor exercise therapy was cost-effective relative to a SSPT using the threshold of £20,000 per quality-adjusted life-year. There were no treatment-related serious adverse events. Conclusions This is the largest RCT to date assessing physiotherapy in participants with OVFs. At 1 year, neither treatment intervention conferred more benefit than a single 1-hour physiotherapy advice session. The focus of future work should be on the intensity and duration of interventions to determine if changes to these would demonstrate more sustained effects. Trial registration Current Controlled Trials ISRCTN49117867. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 44. See the NIHR Journals Library website for further project information.

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Development and delivery of an exercise intervention for rheumatoid arthritis: Strengthening and stretching for rheumatoid arthritis of the hand (SARAH) trial

Cited by 47 publications

References 25 publications

The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial)

The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial)

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

Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT

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