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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.

ABSTRACT: BACKGROUND: Rheumatoid 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/DESIGN: 480 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. DISCUSSION: This 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.

SUBMITTER: Sarah Trial Team

PROVIDER: S-EPMC3517760 | biostudies-other | 2012

REPOSITORIES: biostudies-other

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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 Jo J Bridle Chris C Dosanjh Sukhdeep S Heine Peter P Lamb Sarah E SE Lord Joanne J McConkey Christopher C Nichols Vivien V Toye Francine F Underwood Martin R MR Williams Mark A MA Williamson Esther M EM

BMC musculoskeletal disorders 20121124

<h4>Background</h4>Rheumatoid 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 opti ...[more]

PMID: 23176133

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Project description:BackgroundThe Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, progressive 12-week exercise program for people with hand problems due to rheumatoid arthritis. The program was shown to be clinically and cost-effective in a large clinical trial and is recommended by the UK National Institute for Health and Care Excellence (NICE) guidelines for rheumatoid arthritis in adults.ObjectiveWe have developed an online version of the SARAH program (mySARAH) to make the SARAH program widely accessible to people with rheumatoid arthritis. The purposes of this study were to develop mySARAH and to evaluate and address its usability issues.MethodsWe developed mySARAH using a three-step process and gaining feedback from patient contributors. After initial development, mySARAH was tested in two iterative usability cycles in nine participants using a simplified think-aloud protocol and self-reported questionnaires. We also evaluated if participants executed the SARAH exercises correctly after watching the exercise videos included on the website.ResultsA preliminary version of mySARAH consisting of six sessions over a 12-week period and delivered via text, exercise videos, images, exercise plan form, exercise calendar, and links to additional information on rheumatoid arthritis was developed. Five participants (1 male; 4 females; median age 64 years) and four participants (four females; median age 64.5 years) took part in the first and second usability testing cycles respectively. Usability issues identified from Cycle 1 such as having a navigation tutorial video and individualised feedback on pain levels were addressed prior to Cycle 2. The need for more instructions to complete the mySARAH patient forms was identified in Cycle 2 and was rectified. Self-reports from both cycles indicated that participants found the program useful and easy to use and were confident in performing the SARAH exercises themselves. Eight of the nine participants correctly demonstrated all the exercises.ConclusionsmySARAH is the first online hand exercise intervention for people with rheumatoid arthritis. We actively involved target users in the development and usability evaluation and ensured mySARAH met their needs and preferences.

Project description:BackgroundDexterous hand function is crucial for completing activities of daily living (ADLs), which typically require precise hand-object interactions. Kinematic analyses of hand trajectory, hand velocity, and grip aperture provide valuable mechanistic insights into task performance, but there is a need for standardized tasks representative of ADLs that are amenable to motion capture and show consistent performance in non-disabled individuals. Our objective was to develop two standardized functional upper limb tasks and to quantitatively characterize the kinematics of normative hand movement.MethodsTwenty non-disabled participants were recruited to perform two tasks: the Pasta Box Task and Cup Transfer Task. A 12-camera motion capture system was used to collect kinematic data from which hand movement and grip aperture measures were calculated. Measures reported for reach-grasp and transport-release segments were hand distance travelled, hand trajectory variability, movement time, peak and percent-to-peak hand velocity, number of movement units, peak and percent-to-peak grip aperture, and percent-to-peak hand deceleration. A between-session repeatability analysis was conducted on 10 participants.ResultsMovement times were longer for transport-release compared to reach-grasp for every movement. Hand and grip aperture measures had low variability, with 55 out of 63 measures showing good repeatability (ICC > 0.75). Cross-body movements in the Pasta Box Task had longer movement times and reduced percent-to-peak hand velocity values. The Cup Transfer Task showed decoupling of peak grip aperture and peak hand deceleration for all movements. Movements requiring the clearing of an obstacle while transporting an object displayed a double velocity peak and typically a longer deceleration phase.DiscussionNormative hand kinematics for two standardized functional tasks challenging various aspects of hand-object interactions important for ADLs showed excellent repeatability. The consistency in normative task performance across a variety of task demands shows promise as a potential outcome assessment for populations with upper limb impairment.

Project description:IntroductionEffective interventions to promote upper-limb recovery poststroke are characterised by intensive and repetitive movements. However, the repetitive nature of practice may adversely impact on adherence. Therefore, the development of rehabilitation devices that can be used safely and easily at home, and are motivating, enjoyable and affordable is essential to the health and well-being of stroke survivors.The Neurofenix platform is a non-immersive virtual reality device for poststroke upper-limb rehabilitation. The platform uses a hand controller (a NeuroBall) or arm bands (NeuroBands) that facilitate upper-limb exercise via games displayed on a tablet. The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke trial aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke.Methods and analysisThirty people poststroke will be provided with a Neurofenix platform, consisting of a NeuroBall or NeuroBands (dependent on impairment level), seven specially designed games, a tablet and handbook to independently exercise their upper limb for 7 weeks. Training commences with a home visit from a research therapist to teach the participant how to safely use the device. Outcomes assessed at baseline and 8 weeks and 12 weeks are gross level of disability, pain, objectively measured arm function and impairment, self-reported arm function, passive range of movement, spasticity, fatigue, participation, quality of life (QOL) and health service use. A parallel process evaluation will assess feasibility, acceptability and safety of the intervention through assessment of fidelity to the intervention measured objectively through the Neurofenix platform, a postintervention questionnaire and semistructured interviews exploring participants' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on QOL and resource use.Ethics and disseminationEthics approval granted from Brunel University London (10249-MHR-Mar/2018-12322-2). Trial results will be submitted for publication in journals, presented at national and international conferences and distributed to people with stroke.Trial registration numberISRCTN60291412; Pre-results.

Project description:ObjectiveRheumatoid arthritis (RA) is a chronic disease leading to joint destruction. Although many studies have addressed factors potentially correlated with the speed of joint destruction, less attention has been paid to the distribution of joint destruction in patients with RA. In this study, destruction of the hand bones in patients with RA was classified into 2 anatomic subgroups, the fingers and the non-fingers, with the aim of analyzing which factors are associated with destruction of the finger joints.MethodsA total of 1,215 Japanese patients with RA were recruited from 2 different populations. The degree of joint destruction was assessed using the total modified Sharp/van der Heijde score (SHS) of radiographic joint damage. The SHS score of joint damage in the finger joints was used as the dependent variable, and the SHS score in the non-finger joints was used as a covariate. Age, sex, disease duration, smoking, C-reactive protein level, treatment for RA, and positivity for and levels of anti-citrullinated protein antibodies and rheumatoid factor (RF) were evaluated as candidate correlates. Overall effect sizes were assessed in a meta-analysis. In addition, associations observed in the Japanese patients were compared to those in a cohort of 157 Dutch RA patients in the BeSt study (a randomized, controlled trial involving 4 different strictly specified treatment strategies for early RA).ResultsNot surprisingly, disease duration in Japanese patients with RA was associated with the finger SHS score (P ≤ 0.00037). Both positivity for and levels of RF showed significant associations with the finger SHS score after adjustment for covariates (P = 0.0022 and P = 8.1 × 10(-7) , respectively). These associations were also true in relation to the time-averaged finger SHS score. An association between RF positivity and the finger SHS score was also observed in Dutch patients with RA in the BeSt study (P = 0.049).ConclusionPositivity for and levels of RF are associated with finger joint destruction independent of non-finger joint destruction and other covariates. Our findings suggest that there are different mechanisms of joint destruction operating in the finger joints of patients with RA.

Project description:Recently, extratheses, aka Supernumerary Robotic Limbs (SRLs), are emerging as a new trend in the field of assistive and rehabilitation devices. We proposed the SoftHand X, a system composed of an anthropomorphic soft hand extrathesis, with a gravity support boom and a control interface for the patient. In preliminary tests, the system exhibited a positive outlook toward assisting impaired people during daily life activities and fighting learned-non-use of the impaired arm. However, similar to many robot-aided therapies, the use of the system may induce side effects that can be detrimental and worsen patients' conditions. One of the most common is the onset of alternative grasping strategies and compensatory movements, which clinicians absolutely need to counter in physical therapy. Before embarking in systematic experimentation with the SoftHand X on patients, it is essential that the system is demonstrated not to lead to an increase of compensation habits. This paper provides a detailed description of the compensatory movements performed by healthy subjects using the SoftHand X. Eleven right-handed healthy subjects were involved within an experimental protocol in which kinematic data of the upper body and EMG signals of the arm were acquired. Each subject executed tasks with and without the robotic system, considering this last situation as reference of optimal behavior. A comparison between two different configurations of the robotic hand was performed to understand if this aspect may affect the compensatory movements. Results demonstrated that the use of the apparatus reduces the range of motion of the wrist, elbow and shoulder, while it increases the range of the trunk and head movements. On the other hand, EMG analysis indicated that muscle activation was very similar among all the conditions. Results obtained suggest that the system may be used as assistive device without causing an over-use of the arm joints, and opens the way to clinical trials with patients.

Project description:BackgroundSubstantial progress has been made in the medical management of rheumatoid arthritis (RA) over the past decade with the introduction of biologic therapies, including anti-tumour necrosis factor alpha (anti-TNFα) therapy medications. However, individuals with RA taking anti-TNFα medication continue to experience physical, psychological and functional consequences, which could potentially benefit from rehabilitation. There is evidence that therapeutic exercise should be included as an intervention for people with RA, but to date there is little evidence of the benefits of therapeutic exercise for people with RA on anti-TNFα therapy medication. A protocol for a multicentre randomised controlled three-armed study which aims to examine the effect of dynamic group exercise therapy on land or in water for people with RA taking anti-TNFα therapy medication is described.Methods/designSix hundred and eighteen individuals with RA, on anti-TNFα therapy medication, will be randomised into one of 3 groups: a land-based exercise group; a water-based exercise group or a control group. The land and water-based groups will exercise for one hour, twice a week for eight weeks. The control group will receive no intervention and will be asked not to alter their exercise habits for the duration of the study. The primary outcome measure, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) which measures functional ability, and secondary measures of pain, fatigue and quality of life, will be assessed at baseline, eight and 24 weeks by an independent assessor unaware of group allocation. Changes in outcome from 0 to 8 weeks and 0 to 24 weeks in the 'land-based exercise group versus control group' and the 'water-based exercise group versus control group' will be examined. Analysis will be conducted on an intention to treat basis.DiscussionThis trial will evaluate the effectiveness of group exercise therapy on land or in water, for people with RA taking anti-TNFα therapy medication. If these exercise groups are found to be beneficial, they could be conducted in local community facilities thus making these forms of exercise more easily accessible for individuals and potentially reduce the burden on health services.Trial registrationThis trial is registered with ClinicalTrials.gov (a service of the United States National Institutes of Health) identifier: NCT00855322.

Dataset Information

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.

Publications

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.

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