Artritis Muñeca

Original Article Arthritis Care & Research
DOI 10.1002/acr.23093
Title: The mediating effect of changes in hand impairments on hand function in patients with
rheumatoid arthritis: exploring the mechanisms of an effective exercise programme
Authors: Amanda M Hall1,2,3 (PhD), Bethan Copsey2* (MMath), Mark Williams2,4 (PhD),
Cynthia Srikesavan2 (PhD), Sarah E Lamb2 (DPhil) on behalf of the SARAH trial team.
1
The George Institute for Global Health, University of Oxford, England, UK.
2
Centre for Rehabilitation Research, Nuffield Department of Orthopaedics Rheumatology
and Musculoskeletal Sciences, University of Oxford, England, UK.

3
Faculty of Medicine, Memorial University, Newfoundland, Canada.
4
Department of Sport and Health Sciences, Oxford Brookes University, England, UK.
Correspondence should be addressed to:
Bethan Copsey, Centre for Statistics in Medicine, Botnar Research Centre, University of
Oxford, Windmill Road, Oxford, OX3 7LD. Tel: 01865 737923. Email:
bethan.copsey@csm.ox.ac.uk.
Supporters of the study: The research was supported by the National Institute for Health
Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at
Oxford Health NHS Foundation Trust. The views expressed are those of the authors and not
necessarily those of the NHS, the NIHR, or the Department of Health. In addition, Dr Hall
was supported by a research fellowship from the Canadian Institutes of Health Research
(CIHR). The SARAH trial, which provided the data source for the study, was funded by the
NIHR Health Technology Assessment (HTA) Programme.
Word count: 3306
This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process which may lead to
differences between this version and the Version of Record. Please cite this article as an
‘Accepted Article’, doi: 10.1002/acr.23093
© 2016 American College of Rheumatology
Received: Mar 24, 2016; Revised: Aug 15, 2016; Accepted: Sep 13, 2016
This article is protected by copyright. All rights reserved.
Page 3 of 29 Arthritis Care & Research
Abstract
Objective: To determine whether the effect of the ‘Strengthening And stretching for
Rheumatoid Arthritis of the Hand’ (SARAH) exercise programme on hand function was
mediated by changes in the proposed active ingredients: strength, dexterity, and/or range
of motion.
Methods: The SARAH intervention included exercises hypothesized to improve potential
mediators of grip strength, pinch strength, wrist flexion, wrist extension, finger flexion,
finger extension, thumb opposition, and dexterity, which would theoretically improve self-
reported hand function. All variables were measured at baseline and at 4 and 12 months.
Structural equation modelling was used to assess mediation on change in hand function via
change in potential mediators.
Results: Change in grip strength partially mediated change in hand function. Grip strength
mediated 19.4% (95% confidence interval: 0.9% to 37.8%) of the treatment effect.
Discussion: Improvements in grip strength at 4 months are likely to mediate improved hand
function at 12 months. The role of joint mobility exercises is less clear and is likely
influenced by the choice of measurement tools for both mobility and function outcomes.
More robust measurements of wrist and hand mobility for patients with rheumatoid
arthritis may be necessary to determine the relationship between this variable and self-
reported hand function.
Conclusion: Using a large trial dataset, we have demonstrated that techniques used to
target grip strength are key active ingredients of the SARAH exercise programme and
mediate its effect.
John Wiley & Sons, Inc. Page 2 of 26

Arthritis Care & Research Page 4 of 29
Significance and Innovations:
• Grip strength was found to mediate the improvements in self-reported hand
function from the SARAH exercise programme.
• This study provides initial evidence that strength training components are active
ingredients that contribute to the effectiveness of the SARAH exercise programme.
• As the role of mobility exercises remains unclear, it is reasonable to continue to
recommend the use of the SARAH intervention as per the proposed protocol,
including both strength and mobility exercises in combination with behavioral
strategies.

Rheumatoid arthritis (RA) is an inflammatory condition affecting people worldwide; its
prevalence in the UK has been reported to be 0.5 – 1.0% (1). RA tends to affect multiple
joints, with a large proportion of patients reporting symptoms in the hand and wrist (2).
Common symptoms of RA of the hand are joint pain and swelling that cause reduced
strength and movement of the hands, impacting a person’s ability to carry out day-to-day
activities, such as turning a key, carrying a shopping bag, or preparing a meal. A
comprehensive and multidisciplinary treatment approach is recommended for RA.
Pharmacological treatments include drugs such as disease-modifying anti-rheumatic drugs
(DMARDs) for modifying disease activity, analgesics for reducing pain, and nonsteroidal anti-
inflammatory drugs (NSAIDs) for reducing pain and joint swelling. Some common
nonpharmacological treatments include physiotherapy and occupational therapies for
improving/maintaining joint mobility, strength, and overall hand function for activities of
daily living (3).
The ‘Strengthening And stretching for Rheumatoid Arthritis of the Hand’ (SARAH)
intervention is an exercise-based programme designed to improve hand and wrist function
in people with RA. It was found to be acceptable to patients and to be clinically and cost
effective within the National Health Service (NHS) in the United Kingdom (UK) (4). The
evaluation of the SARAH intervention randomly allocated 490 adults with RA of the hand to
a control group consisting of usual care (one to three sessions, including education about
protecting joints, general exercise advice, and splints if needed) or to an intervention group
of usual care plus the SARAH programme. The exercise programme resulted in better hand
function at 4 and 12 months’ follow-up compared with usual care. Importantly, it did not

cause an increase in pain or side effects, and most patients reported being very satisfied
with the treatment they received (4). When testing complex interventions such as SARAH,
the UK’s Medical Research Council (MRC) stresses that it is insufficient to simply
demonstrate the effectiveness of the intervention. The MRC highlights the importance of
conducting a process evaluation that includes assessing proposed mediators of the
treatment outcome, to provide insights to aid implementation and improve clinical
outcomes in practice (5).
Description of the SARAH intervention
The SARAH intervention is a multicomponent exercise and education intervention that was
designed to target common problems of RA of the hand, including weakness due to muscle
atrophy and reduced mobility (range of motion and dexterity) due to joint restrictions. The
exercise programme was devised by triangulating information from the existing evidence
base, current clinical guidelines, and the results of an expert consensus process. The SARAH
programme was pilot-tested with patients for acceptability. A full description of the
development and delivery of SARAH was previously published as per MRC
recommendations for evaluating complex interventions (6).
The resulting SARAH intervention included exercises to increase muscular strength (e.g.,
gross grip and pinch grip) and to improve range of motion and dexterity (e.g., tendon
gliding, radial walking, and wrist circumduction). The programme included seven mobility
exercises and four strength exercises using resistance materials. Its components are
described in Figure 1 (Intervention map). The intervention was delivered through six face-to-
face sessions with a hand therapist, supported by a daily home exercise programme. Clear
criteria based on the principles of general strength training were followed for progressing

and, if necessary, regressing the exercises. It was hypothesized that by engaging in the
SARAH progressive hand exercise and education intervention, patients would experience
improvements in hand and wrist range of motion, dexterity, and strength that would
subsequently lead to changes in hand function (6). Figure 2 presents the theoretical model
linking the intervention components to patient outcomes. In this study, the causal
mediation effects of SARAH for RA of the hand will be estimated.
To facilitate adherence to the exercise programme, the participants were provided with an
exercise diary, undertook goal setting plans, assessed their confidence levels in performing
the exercises, and completed a contracting process with the therapist that aimed to
strengthen the intention, motivation, and confidence to regularly exercise. Exercise diaries
and contracting documents were reviewed at each session. All materials relating to the
SARAH intervention are available online (http://www.octru.ox.ac.uk/trials/trials-
completed/SARAHtrial/sarah-trial-materials). A previous analysis of treatment adherence
revealed that treatment attendance was high; 75% of the intervention arm attended all six
sessions, and 93% of the usual care arm completed their single treatment session. In both
groups, core components of treatment session(s) were delivered in at least 70% of cases,
indicating that therapists complied well with the protocol (4). A subsequent complier
average causal effect (CACE) analysis also indicated that full adherence to the SARAH
programme had a slightly larger treatment effect in comparison with usual care.
Aim
It was thus the aim of this study to determine whether the effect of the SARAH intervention
on hand function was indeed mediated by changes in strength and mobility as proposed.

Our objective was to estimate the extent to which each of the pre-specified proposed
variables (wrist and hand range of motion, dexterity, pinch strength, and/or grip strength)
mediated the effect on hand function. Our secondary aim was to explore whether the
intervention could be refined based on the mediation results.
MATERIALS AND METHODS
Design
This study used a causal mediation analysis of a two-arm randomized controlled trial (RCT).
The complete methods of the SARAH trial are described in full in a published monograph
(Trial registration: ISRCTN89936343) (7). A shortened version of the methods required for
the mediation analysis is described here.
Participants and recruitment
People with RA, meeting the American College of Rheumatology clinical and immunological
criteria, with pain and dysfunction of the hands and/or wrist joints (8) who were either not
on DMARDs, or for the previous three months or more had been on a stable DMARD
regimen were included in the study. Exclusion criteria included: (i) patients recovering from
upper limb joint surgery or fracture in the previous six months, (ii) patients on a waiting list
for upper limb orthopedic surgery, (iii) patients who were pregnant, and (iv) patients aged
less than 18 years. Participants were recruited from referrals to, and from current patients
of, rheumatology units at 12 NHS Trusts across England.
Ethical considerations

Patients gave written informed consent in accordance with the principles of the Declaration
of Helsinki. The trial was approved by the Oxford C Multicentre Research Ethics Committee
(REC reference 08/H0606/47).
Randomization and blinding
Participants were randomly allocated to usual care or usual care plus the SARAH exercise
programme via a central telephone randomization service at Warwick Clinical Trials Unit,
University of Warwick. The randomization sequence was computer generated and stratified
by center. Outcome assessors were blind to the group allocation of the participant and were
independent of intervention delivery.
Interventions
Control arm participants received usual care, described as joint protection information,
splinting, assistive devices, and other general advice as required. In addition to the control
treatment, participants in the intervention arm received the SARAH exercise programme,
which was delivered over six sessions of approximately 30 minutes spread over a 12-week
period.
Outcome assessment
All treatment outcomes and proposed mediating variables were assessed at baseline (T0)
and at 4 months (T1) and 12 months (T2) after randomization.
Treatment outcome

The primary outcome used in the SARAH trial was hand function assessed using the
Michigan Hand Outcomes Questionnaire (MHQ) overall hand function subscale score (9).
The MHQ overall hand function subscale contains five items. Individual item scores are
summed to give a raw score for the scale, which is then converted to a score between 0 and
100 using the MHQ scoring algorithms. Cases with three or more missing items were
excluded from the analysis (9).
Proposed mediating variables
The proposed mediating variables were those that were specifically targeted by the SARAH
exercise programme, including wrist flexion and wrist extension measured from the neutral
position with a goniometer (10); finger flexion, finger extension, and thumb opposition
assessed according to protocols of Ellis and Bruton (11) and Kapandji (12); and full hand grip
strength and tripod pinch strength assessed using the MIE Digital Grip analyser (MIE Medical
Research Ltd, Leeds, UK) (13). Dexterity was assessed using the nine-hole peg test (14).
Importantly, each of the assessments followed carefully standardized protocols for limb
positioning and procedures. Further regular quality assurance checks were conducted at
random to ensure testing validity. A full description of the outcome measures and testing
procedures is presented in Table 1.
Statistical analysis
Following the criteria outlined by Baron and Kenny for determining the validity of proposed
mediating variables, each of the proposed mediators was tested to determine if the SARAH
intervention had a significant effect on the variable at 4 months (15). If no significant
treatment effect was found at 4 months, the proposed mediating variable was excluded

from further analysis. Single mediator models were created to test each potentially
mediating variable individually. The change scores for finger flexion and dexterity were
reversed as a lower score indicated improvement. We also planned to create a simultaneous
mediation model including all of the mediating variables whose single mediator models
found full or partial mediation. However, this proved to be inappropriate in this instance.
The 95% CI for the ratio of the indirect effect to the total effect (i.e., the proportion of the
effect mediated) was calculated using the delta method (16). All of the models were
adjusted for overall hand function at baseline. A secondary analysis adjusting for center,
age, sex, and drug use (DMARDs and steroids as separate variables) was conducted.
Structural equation modelling (SEM) was used (17). All analyses were conducted using Stata
IC 14.
RESULTS
Main findings of the SARAH trial
The patient sample for the original trial included 488 participants, 246 allocated to
intervention group and 242 allocated to the control group. The patients had a mean age of
61.3 years (SD 12) in the intervention group and 63.5 years (SD 11) in the usual care group.
Overall, 374 participants (76%) were female. On average, the participants received their
diagnosis of rheumatoid arthritis 10 years prior to entering the trial. More than 90% of the
participants were treated with biological or non-biological DMARDs, with adalimumab and
etanercept the most common biologicals and methotrexate the most common non-
biological. At baseline, the mean overall hand function score in each group was 52.1 for the
primary outcome, the MHQ. The trial had a follow-up rate of 92% at 4 months and 89% at
12 months for the MHQ, and analysis of this outcome found a significant treatment effect.

Treatment compliance was high across both treatment groups, and the trial found no
significant changes in treatment effect between subgroups on age, gender, disease activity,
or medication usage.
Determining the validity of the proposed mediating variables
Although the intervention was associated with positive effects on all potential mediators,
the effect was only significant for grip strength (Table 2). There may be two explanations for
this finding: (i) the study design lacked power to detect significance on the secondary
variables and/or (ii) the chosen assessment tools for the mobility variables may not have
been sensitive enough to detect change. Only grip strength fulfilled Baron and Kenny’s first
criterion of a significant treatment effect on the proposed mediator, so was included in the
mediation analysis (4). For the reasons listed above, it would be premature to include the
mobility variables as mediators, as this would underestimate the effects of changes in range
of motion (ROM) and dexterity. As only one eligible mediator was found, a multiple
mediator model was not suitable.
Results of mediation analyses
Single mediator model
A single mediator model was used to test grip strength individually, the results of which are
shown in Table 2. Significant partial mediation was found for change in grip strength. Grip
strength was found to mediate 19.4% (95% CI: 0.9% to 37.8%) of the treatment effect. A
secondary analysis adjusting for center, sex, age, and drug use found similar results. Only
the results from the adjusted analysis are presented.

DISCUSSION
This study aimed to test whether the observed treatment effect on hand function in the
SARAH trial was mediated by the pre-specified proposed variables. The study used a
structural equation modelling design with a sufficiently large patient sample to test whether
eight pre-specified variables mediated the treatment effect. Grip strength was found to
have a significant mediating effect that explained 19% of the total treatment effect on
overall hand function. This result provides evidence that at least part of the treatment effect
was due to improvements in physiological factors, as proposed in our theoretical model. As
we found only partial mediation via improving hand strength, it is likely that other factors
can also explain the improvement in function.
The finding that change in grip strength had a significant mediating role in change of hand
function is reassuring, considering previous research. Although no previous studies have
been published that investigate the mediating value of grip strength for hand function,
multiple studies have found grip strength to correlate with and have prediction value for
both self-reported hand function (18-20) and performance-based hand function tests (e.g.,
hand dynamometry) (21). Previous studies have also reported that people with RA are likely
to have approximately 50% less hand strength compared to healthy referents, and that
hand exercise programmes that include a hand strengthening component may be effective
in improving hand function (20, 22).
We found that mobility measured by finger, wrist, or thumb range of motion, or finger
dexterity did not satisfy Baron and Kenny’s first criterion and thus excluded these measures
as putative mediators. The lack of an observed relationship between treatment allocation

and any of the mobility variables could have been due to several factors. First, the main
analysis was powered to detect changes in the primary outcome, hand function. It is
possible that the design lacked sufficient power to detect statistically significant changes in
the secondary mobility variables. Second, it is possible that there was no substantial change
in mobility with the SARAH intervention. The evidence on the effectiveness of exercise
treatments such as the commonly used programme described by Flatt (23) for improving
mobility is inconsistent (6). Third, the choice of outcome measures for both function and
mobility could have influenced the results. For example, we assessed hand function with a
patient self-reported measure, the MHQ, which is commonly used in studies of RA
populations. However, the MHQ has been shown to have low correlation with finger and
thumb mobility (e.g., thumb opposition and finger flexion/extension tests). An objective test
of hand function such as the Sollerman Grip function test (24), which has a stronger
relationship with finger and thumb mobility, may have been more likely to show a
relationship, had one existed. Additionally, we used the nine-hole peg test to measure
dexterity, which measures the time taken to complete a peg and hole task, rather than
measuring task performance or movement quality. The peg test may not correlate with
hand function as well as a more RA-specific measure, like the Sequential Occupational
Dexterity Assessment (SODA) (24). Furthermore, although there is evidence to support the
reliability and validity of our mobility outcome measures in healthy individuals (10-12), the
psychometric properties have not been well established in an RA population. The ability of
these measures to detect substantial change is unknown and this may have contributed to
the lack of a treatment effect.

Although there is no clear evidence on the relationship between mobility exercises and
hand function, there is consistent evidence of mobility exercises resulting in increased grip
strength (26-28). Thus, it is likely that some mobility exercises may also indirectly improve
strength. Indeed, many of the mobility exercises used in the SARAH trial could have
improved hand strength through isometric muscle work and eccentric contraction. It is for
this reason, in combination with the choice of mobility measurement tools, that it would
premature to exclude mobility as a potential mediator of the SARAH exercise intervention.
To more accurately determine the role of mobility exercises for improving strength,
mobility, and function, a more robust assessment with psychometrically sound
measurement tools using a design that can test the effects of the SARAH intervention with
or without the mobility exercises is required.
Clinical and research implications
Our analysis suggests that its strength training components contributed to the effectiveness
of the SARAH programme in improving hand function. Mediation by grip strength is
reassuring: the corresponding exercises are easy to perform and are commonly prescribed,
so should be easy for clinicians to replicate and for patients to adhere to in clinical
situations.
From our analysis, it is difficult to draw any conclusions regarding the role of exercises
targeting hand and wrist mobility in improving overall hand function, largely due to the lack
of psychometrically sound measurement tools for these variables in this population and the
possible lack of power to determine a treatment effect. Many studies that have looked at
exercise programs with RA of the hand include mobility exercises, either alone or with

strengthening exercises. While there is some evidence that combining strength and mobility
is better than mobility alone (26), there is limited evidence on the effect of programmes
that solely target strength. As stated previously, many of the mobility exercises used in
SARAH may also improve hand strength. We are therefore unable to provide evidence to
suggest that clinicians should exclude mobility exercises or only provide exercises primarily
aimed at strengthening.
Strengths and limitations
First, the measurement tools used to assess mobility in the original trial may have limited
the potential to observe a substantial treatment effect, precluding the validity of these
variables as putative mediators. We were therefore unable to explore the potential
mediating effect of these variables. Second, although the mediator was measured before
the outcome during the SARAH trial, our determination of causality, per se, is limited as
improved hand function during the exercise programme could have improved grip strength.
We would need a series of repeated measures to determine causality, during which we
would expect the first change in either variable to occur during the exercise programme. As
these data are not available, our conclusions on causality are limited to suggesting that
changes in grip strength at 4 months are likely to be on the causal pathway for sustaining
improvements in long-term hand function at 12 months.
Future research
We recommend that future assessment of function in patients with RA of the hand should
include both a self-reported measure, such as the MHQ, and an objective measure, such as
the Sollerman test (24) or the Arthritis Hand Function test (29). Similarly, for greater

certainty around measures of mobility in this population, we recommend using SODA for
dexterity to assess quality of movement. We suggest that further research is required to
develop and clinically validate high quality measurement tools for other impairment-based
measures, such as joint ROM.
Although we found no confirmatory evidence to reduce the number of exercises in the
SARAH intervention in this analysis, we recognize that there may be value in determining
whether the same effect could be gained with a shorter, refined version of the SARAH
treatment. Thus, to help improve the efficiency of complex exercise programmes, further
high quality research could investigate the value of hand strengthening exercises (without
mobility exercises) supported with behavioral strategies and the dose-response
relationships of these programmes.
Conclusions
This study shows that the effect of the SARAH intervention is due in part to physical factors,
specifically grip strength. It provides initial evidence that techniques used to target grip
strength may be the key active ingredients that mediate the effect of the SARAH exercise
programme. Therefore, therapists should at minimum incorporate exercises targeting grip
strength into programmes for patients with hand problems due to RA. However, uncertainty
still exists regarding the relative mechanistic effects of mobility exercises.
Acknowledgements
We would like to acknowledge Dr Esther M Williamson and Mr Peter J Heine for their role in
developing and evaluating the SARAH intervention.

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TABLES

Table 1. Description of outcome measures
Variable (tool) Measurement Tool Description
Hand Function Overall hand function subscale (five items rated on a 5-point scale for
(MHQ) each hand). The summed score was the mean for the two hands.
Gross grip strength The standard test position recommended by the American Society of
and tripod pinch Hand Therapists was used. The mean of three maximal 3-second grips
strength was calculated for each hand, with 60-second rests between repetitions.
(Dynamometer)
Finger flexion and Flexion and extension was assessed using a ruler according to Ellis and
extension Bruton. Four measurements per hand provided a single score for each
hand, which were combined to provide an overall average score.
Thumb opposition The thumb opposition score was assessed using a ruler according to
Kapandji (a count for each hand).
Wrist flexion and Active wrist flexion and extension. Two measurements per hand were
extension summarized as a single score for each hand and combined to provide an
(Goniometer) average score.
Finger dexterity Participants were timed to place nine pegs into nine holes, then remove
(nine-hole peg them as fast as they could. The dominant arm was tested first, with one
board) practice trial per arm. Timing started when the patient touched the first

peg and stopped when the patient placed the last peg in the container.

Table 2. Outcomes from the SARAH trial
Mean change from baseline (95% CI)**

Usual care Exercise Mean treatment P value N
difference (95% CI)*
Overall hand function at 12 months 3.56 (1.45 to 5.68) 7.93 (5.98 to 9.88) 4.35 (1.61 to 7.09) 0.002 438
Full-hand grip force at 4 months (Newtons) 7.98 (3.45 to 12.51) 16.43 (11.33 to 21.52) 8.43 (1.64 to 15.22) 0.015 403
Pinch grip force at 4 months (Newtons) 2.91 (1.47 to 4.35) 4.05 (2.62 to 5.48) 1.13 (-0.90 to 3.16) 0.276 401
Combined finger flexion at 4 months (mm) 3.48 (2.30 to 4.66) 4.48 (3.10 to 5.86) 1.07 (-0.71 to 2.86) 0.238 406
Combined finger extension at 4 months 1.34 (-0.58 to 3.26) 4.00 (1.92 to 6.08) 2.67 (-0.15 to 5.49) 0.064 403
(mm)
Active wrist extension score at 4 months 1.35 (-0.04 to 2.74) 1.50 (0.06 to 2.93) 0.18 (-1.81 to 2.17) 0.860 405
(degrees)
Active wrist flexion score at 4 months 1.30 (0.08 to 2.52) 3.34 (1.86 to 4.82) 2.06 (0.15 to 3.97) 0.034 406
(degrees)
Thumb opposition score at 4 months 0.17 (0.00 to 0.35) 0.23 (-0.01 to 2.74) 0.06 (-0.24 to 0.35) 0.709 406
Dexterity at 4 months 0.74 (-0.03 to 1.50) 1.08 (0.24 to 1.92) 0.33 (-0.80 to 1.46) 0.563 405
* Calculated using a regression model adjusting for baseline hand function

** Baseline scores in hand function and proposed mediators were balanced across treatment arms
Page 24 of 26
John Wiley & Sons, Inc.

Table 3. Effect size estimates of the total, direct, and mediated (indirect) effects of improved grip strength at 4 months on hand
function at 12 months.
Outcome Total Effect Direct Effect Indirect Effect Proportion Mediated

MEDIATOR
Effect Size* (95% CI) Effect size (95% CI) Effect size (95% CI) % n=
p-value p-value p-value p-value

Grip Strength
Hand Function 4.35 (1.51 to 7.19) 3.50 (0.71 to 6.29) 0.85 (0.10 to 1.60) 19.4% (0.9% to 37.8%) 387
p<0.01 p=0.01 p=0.03

(MHQ)
*Effect sizes are non-standardized coefficients
**The results are adjusted for age, sex, center, and drug use and therefore are presented as unstandardized effect sizes using the parameter estimate for the MHQ
Page 25 of 26

FIGURE LEGENDS
Figure 1. Intervention map

1,2
Illustrations of the strength and mobility exercises can be found in Appendix 1.
Figure 2. Theoretical model

Figure 1. Intervention map

1, 2: Illustrations for strength and mobility exercises are shown in Appendix 1.
193x67mm (96 x 96 DPI)

Figure 2. Theoretical model
134x67mm (300 x 300 DPI)

Target Outcome Exercise name Image

Improve Strength of the:
 Wrist extensors Eccentric wrist extension
 Hand and forearm Gross grip
 Finger adductors Finger adduction
 Fingers and thumb flexors Pinch grip
Improve Mobility of the:

 Metacarpal joints MCP flexion
 Flexor and extensor tendons Tendon gliding
 Metacarpal joints and flexor Finger radial walking

tendons
 Wrist joints and soft tissues Wrist circumduction
 Hand joints and soft tissues Finger abduction
 Shoulder and elbow Hand-behind-head
 Shoulder and elbow Hand-behind-back


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Original Article Arthritis Care & Research

rheumatoid arthritis: exploring the mechanisms of an effective exercise programme

and Musculoskeletal Sciences, University of Oxford, England, UK.

Correspondence should be addressed to:

NIHR Health Technology Assessment (HTA) Programme.

Word count: 3306

Methods: The SARAH intervention included exercises hypothesized to improve potential

change in potential mediators.

reported hand function.

mediate its effect.

John Wiley & Sons, Inc. Page 2 of 26

This article is protected by copyright. All rights reserved.

Significance and Innovations:

• Grip strength was found to mediate the improvements in self-reported hand

function from the SARAH exercise programme.

ingredients that contribute to the effectiveness of the SARAH exercise programme.

• As the role of mobility exercises remains unclear, it is reasonable to continue to

including both strength and mobility exercises in combination with behavioral

John Wiley & Sons, Inc. Page 3 of 26

This article is protected by copyright. All rights reserved.

Rheumatoid arthritis (RA) is an inflammatory condition affecting people worldwide; its

activities, such as turning a key, carrying a shopping bag, or preparing a meal. A

comprehensive and multidisciplinary treatment approach is recommended for RA.

Pharmacological treatments include drugs such as disease-modifying anti-rheumatic drugs

nonpharmacological treatments include physiotherapy and occupational therapies for

daily living (3).

intervention is an exercise-based programme designed to improve hand and wrist function

John Wiley & Sons, Inc. Page 4 of 26

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conducting a process evaluation that includes assessing proposed mediators of the

treatment outcome, to provide insights to aid implementation and improve clinical

outcomes in practice (5).

Description of the SARAH intervention

development and delivery of SARAH was previously published as per MRC

recommendations for evaluating complex interventions (6).

John Wiley & Sons, Inc. Page 5 of 26

This article is protected by copyright. All rights reserved.

mediation effects of SARAH for RA of the hand will be estimated.

SARAH intervention are available online (http://www.octru.ox.ac.uk/trials/trials-

completed/SARAHtrial/sarah-trial-materials). A previous analysis of treatment adherence

John Wiley & Sons, Inc. Page 6 of 26

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intervention could be refined based on the mediation results.

MATERIALS AND METHODS

the mediation analysis is described here.

Participants and recruitment

of, rheumatology units at 12 NHS Trusts across England.

John Wiley & Sons, Inc. Page 7 of 26

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(REC reference 08/H0606/47).

Randomization and blinding

independent of intervention delivery.

and at 4 months (T1) and 12 months (T2) after randomization.

John Wiley & Sons, Inc. Page 8 of 26

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excluded from the analysis (9).

Proposed mediating variables

procedures is presented in Table 1.

intervention had a significant effect on the variable at 4 months (15). If no significant

John Wiley & Sons, Inc. Page 9 of 26

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reversed as a lower score indicated improvement. We also planned to create a simultaneous

Main findings of the SARAH trial

John Wiley & Sons, Inc. Page 10 of 26