scholarly journals Gait Rehabilitation for Foot and Ankle Impairments in Early Rheumatoid Arthritis: a Feasibility Study of a New Gait Rehabilitation Programme (GREAT Strides)

2022 ◽  
Author(s):  
Gordon Hendry ◽  
Lindsay Bearne ◽  
Nadine E Foster ◽  
Emma L Godfrey ◽  
Samantha Hider ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Feasibility Study ◽  
Early Rheumatoid Arthritis ◽  
Lower Limb ◽  
Gait Rehabilitation ◽  
Future Trial ◽  
Intervention Acceptability ◽  
Foot Function ◽  
Lower Limb Function

Abstract BackgroundFoot impairments in early rheumatoid arthritis are common and lead to progressive deterioration of lower limb function. A gait rehabilitation programme underpinned by psychological techniques to improve adherence, may preserve gait and lower limb function. This study evaluated the feasibility of a novel gait rehabilitation intervention (GREAT Strides) and a future trial. MethodsThis was a mixed methods feasibility study with embedded qualitative components. People with early (<2 years) rheumatoid arthritis (RA) and foot pain were eligible. Intervention acceptability was evaluated using a questionnaire. Adherence was evaluated using the Exercise Adherence Rating Scale (EARS). Safety was monitored using case report forms. Participants and therapists were interviewed to explore intervention acceptability. Deductive thematic analysis was applied using the Theoretical Framework of Acceptability. For fidelity, audio recordings of interventions sessions were assessed using the Motivational Interviewing Treatment Integrity (MITI) scale. Measurement properties of four candidate primary outcomes, rates of recruitment, attrition and data completeness were evaluated.Results35 participants (68.6% female) with median age (inter-quartile range [IQR]) 60.1 [49.4-68.4] years and disease duration 9.1 [4.0-16.2] months), were recruited and 23 (65.7%) completed 12-week follow-up. Intervention acceptability was excellent; 21/23 were confident that it could help and would recommend it; 22/23 indicated it made sense to them. Adherence was good, with a median [IQR] EARS score of 17/24 [12.5-22.5]. One serious adverse event that was unrelated to the study was reported. Twelve participants’ and 9 therapists’ interviews confirmed intervention acceptability, identified perceptions of benefit, but also highlighted some barriers to completion. Mean MITI scores for relational (4.38) and technical (4.19) aspects of motivational interviewing demonstrate good fidelity. The Foot Function Index disability subscale performed best in terms of theoretical consistency and was deemed most practical. ConclusionGREAT Strides was viewed as acceptable by patients and therapists, and we observed high intervention fidelity, good patient adherence and no safety concerns. A future trial to test the additional benefit of GREAT Strides to usual care will benefit from amended eligibility criteria, refinement of the intervention and strategies to ensure higher follow-up rates. The Foot Function Index disability subscale was identified as the primary outcome.Trial registrationISRCTN14277030

scholarly journals P125 A mixed methods feasibility study of a gait rehabilitation programme for people with early rheumatoid arthritis and foot pain

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Gordon J Hendry ◽  
Lindsay Bearne ◽  
Nadine Foster ◽  
Emma Godfrey ◽  
Samantha Hider ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Mixed Methods ◽  
Feasibility Study ◽  
Lower Limb ◽  
Primary Outcome ◽  
Rehabilitation Programme ◽  
Gait Rehabilitation ◽  
Foot Pain ◽  
Main Trial ◽  
Intervention Acceptability

Abstract Background Foot pain, a hallmark feature of rheumatoid arthritis (RA), is associated with slow and unsteady gait patterns, and persistent walking disability is common. Great Strides is a new gait rehabilitation programme designed to improve/preserve lower limb function in early RA. It is delivered by physiotherapists or podiatrists over 12-weeks and is supplemented with a home programme and support materials (DVD and illustrated booklet). It consists of a 6-task gait circuit and is underpinned by behaviour change techniques driven by motivational interviewing. The aims of this feasibility study were to 1) evaluate patient acceptability, adherence to, and safety of Great Strides, and 2) identify a suitable primary outcome measure for the main trial. Methods This study was a multi-centre (n = 3), single arm, repeated measures (pre- and post-intervention) design, with interviews exploring participants’ intervention perceptions. People with early (&lt;2 years) RA who had foot pain were invited to participate. Intervention acceptability was evaluated using a 3-item intervention acceptability questionnaire. Adherence was evaluated using the Exercise Adherence Rating Scale (EARS). Safety was monitored using case report forms. Complementary mixed methods integrated descriptive quantitative acceptability, adherence, safety and thematic analyses to corroborate findings. Measurement properties of candidate primary outcomes (10-metre walking time, Foot Function Index disability subscale [FFI-DS], Recent Onset Arthritis Disability lower extremity subscale, and Patient-Reported Outcomes Measurement Information System physical function short-form) were evaluated against a 7-point Change in Walking Ability scale (CWA). Results 35 participants (68.6% female) with median age (inter-quartile range [IQR]) 60 [49-68] years and disease duration 9 [4-16] months), were recruited over 9 months and 23 (67%) completed 12-week follow-up. 12 participants completed interviews after the 12-week intervention period. Intervention acceptability was excellent; 21/23 were confident that it could help the problem; 21/23 reported that they would recommend it to a friend; 22/23 indicated it made sense to them. Intervention adherence was moderate, with a median [IQR] EARS score of 12/24 [7-19]. 1 participant reported transient post-exercise soreness. No serious adverse events were reported that were related to the intervention. From interviews, 10/12 participants reported they had continued with the intervention after 12-weeks. Participants revealed that the intervention provided structure and control to their day/week. Additional perceptions of benefit reported included improvements to lower limb joint health, and feelings of increased confidence to return to, or progress to further exercise in the community. The main challenge identified by some participants was lack of space to do the intervention at home. Correlations with the CWA were better for FFI-DS change-scores. Conclusion Great Strides has excellent acceptability and appears safe for people with early RA. Levels of adherence may be improved by intervention refinement. FFI-DS scores were theoretically consistent for selection as primary outcome for the main trial. Disclosures G.J. Hendry None. L. Bearne None. N. Foster None. E. Godfrey None. S. Hider None. M. van der Leeden None. H. Mason None. A. McConnachie None. I. McInnes None. A. Patience None. C. Sackley None. M. Sekhon None. A. Williams None. J. Woodburn None. M. Steultjens None.

scholarly journals P105 Therapists acceptability of delivering a psychologically informed gait rehabilitation intervention in early rheumatoid arthritis (GREAT): a qualitative interview study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Mandeep Sekhon ◽  
Emma Godfrey ◽  
Gordon Hendry ◽  
Nadine E Foster ◽  
Samantha Hider ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Feasibility Study ◽  
Early Rheumatoid Arthritis ◽  
Self Efficacy ◽  
Gait Rehabilitation ◽  
Opportunity Costs ◽  
Perceived Effectiveness ◽  
Structured Interviews ◽  
Intervention Delivery ◽  
Affective Attitude

Abstract Background Great Strides is a brief psychologically informed gait rehabilitation intervention (two compulsory face-to-face sessions and up to four optional sessions delivered over 3 months) aimed at improving lower limb function for adults with early rheumatoid arthritis (RA). As part of the Gait Rehabilitation in Early Arthritis Trial (GREAT) feasibility study, physiotherapists and podiatrists received two days of bespoke training delivered by psychologists, physiotherapists and podiatrists on i) the gait rehabilitation exercise programme (six walking exercises) ii) aspects of motivational interviewing (MI) and iii) delivery of key behaviour change techniques (BCTs) to facilitate motivation and adherence to the Great Strides intervention. The training was supported by a bespoke therapist manual and session checklists. The aim of this study was to explore therapists’ acceptability of: (1) the bespoke training received and (2) delivering the intervention within the GREAT feasibility study. Methods All 10 therapists who received training were invited to complete semi-structured interviews. The topic guide was informed by the Theoretical Framework of Acceptability (TFA). Interviews were audio recorded, professionally transcribed and a deductive thematic analysis was applied. Data were coded into six TFA constructs (Affective Attitude; Burden; Intervention Coherence; Opportunity Costs; Perceived Effectiveness; Self-efficacy). Results Nine out of ten therapists (four physiotherapists, five podiatrists) participated in the semi-structured interviews. Five therapists (four physiotherapists, one podiatrist) delivered the Great Strides intervention. Key barriers and enablers with regards to the acceptability of the bespoke training and intervention delivery were identified. Training: Therapists liked the supportive training environment (affective attitude), understood the purpose of the training sessions (intervention coherence), reported that the role play exercises aided their confidence in applying MI and BCTs (self-efficacy) and found that the training sessions were vital preparation for delivering the intervention (perceived effectiveness). Aspects of training which were considered unacceptable included the lack of time to attend the training sessions (opportunity costs). Delivery: All therapists enjoyed applying MI and BCTs to encourage participants to complete the gait exercises (affective attitude) and valued the opportunity to provide individualised care (intervention coherence). Barriers associated with acceptability included the use of trial-related materials (e.g. checklist) during intervention delivery (burden), interference of intervention delivery with routine clinical workload (opportunity costs) and the time delay between receiving training and initial intervention delivery (perceived effectiveness). Conclusion Both GREAT intervention training and delivery were considered acceptable to most therapists. The results have guided key refinements for training and intervention delivery for the GREAT internal pilot and full trial (e.g. remote access to training, timing of training in relation to intervention delivery). These refinements have the potential to improve the bespoke training and enhance the delivery of the Great Strides intervention maximising efficiency and potential for effectiveness. Disclosures M. Sekhon None. E. Godfrey None. G. Hendry None. N.E. Foster None. S. Hider None. M. van der Leeden None. H. Mason None. A. McConnachie None. I. McInnes None. A. Patience None. C. Sackley None. M. Steultjens None. A. Williams None. J. Woodburn None. L. Bearne None.

scholarly journals P221 Treatment fidelity in the Gait Rehabilitation in Early Rheumatoid Arthritis Trial (GREAT) feasibility study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Emma Godfrey ◽  
Mandeep Sekhon ◽  
Gordon Hendry ◽  
Nadine E Foster ◽  
Samantha Hider ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Motivational Interviewing ◽  
Feasibility Study ◽  
Early Rheumatoid Arthritis ◽  
Treatment Fidelity ◽  
Gait Rehabilitation ◽  
Behaviour Change Techniques ◽  
High Fidelity ◽  
Fidelity Assessment ◽  
Core Elements

Abstract Background Many people with early rheumatoid arthritis (RA) report foot pain and walking disability. Self-reported walking disability two years post-diagnosis is the main predictor of persistent disability. A psychologically informed gait rehabilitation intervention (Great Strides) for early RA was developed to address this, consisting of two compulsory sessions and up to four optional sessions delivered over three months. Physiotherapists and podiatrists received bespoke training to deliver Great Strides, incorporating motivational interviewing (MI) and behaviour change techniques (BCTs), to help patients to complete their walking exercises at home. The aim of this study was to assess fidelity of delivery within the Gait Rehabilitation in Early Arthritis Trial (GREAT) feasibility study. Methods Four physiotherapists and two podiatrists delivered 78 Great Strides sessions across three centres in the UK. All sessions were audio recorded and double coded. The Motivational Interviewing Treatment Integrity (MITI) Rating Scale (scoring ≥4 represents good proficiency) and tailored treatment fidelity measures of the six core elements and 17 BCTs delivered in session 1, five core elements delivered in session 2, and 12 BCTs in session 2-6, were developed to examine fidelity of delivery. Two trained, independent assessors rated audio recordings of Great Strides and assessed the extent to which core elements, aspects of MI and BCTs were delivered across sessions. Results Data from 28 (80%) adult participants across a total of 64 sessions were rated for core components and BCTs and 37 (50%) of sessions were analysed for MI. Relational (score=4.4) and technical (score=4.2) aspects of MI were delivered with good fidelity across the whole sample. The 6 core elements and 7 BCTs in Session 1 were conveyed with high (over 80%) treatment fidelity, but 10 further BCTs were not consistently delivered (range 23-69%). In session 2, the 5 core elements and 3 BCTs were provided with high fidelity, but another 9 BCTs were not reliably delivered (range 11-56%). Sessions 3 and 4 reliably delivered 3 out of 12 BCTs and only one session 5 and 6 was delivered. Inter-rater reliability showed agreement of over 80% was reached between raters for all sessions (range 82-87%). Conclusion Physiotherapists and podiatrists were able to deliver the core elements of GREAT sessions with high fidelity and fidelity assessment methods were appropriate. Results showed a maximum of 4 sessions was sufficient. However, treatment fidelity might be enhanced with further training or greater on-going support, as findings suggested clinicians (physiotherapists) with previous MI experience were more proficient at offering key elements of MI. Additionally, the Great Strides intervention could be amended to improve delivery, as research shows complex interventions should consider mandatory BCTs alongside optional ones, depending on the needs of individual participants. Disclosures E. Godfrey None. M. Sekhon None. G. Hendry None. N.E. Foster None. S. Hider None. M. van der Leeden None. H. Mason None. A. McConnachie None. I. McInnes None. A. Patience None. C. Sackley None. M. Steultjens None. A. Williams None. J. Woodburn None. L. Bearne None.

scholarly journals OP0121 Enbrel® (etanercept) vs. methotrexate (mtx) in early rheumatoid arthritis (era trial): two-year follow-up

2001 ◽  
Author(s):  
M Genovese ◽  
RW Martin ◽  
R Fleischmann ◽  
E Keystone ◽  
J Bathon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Early Rheumatoid Arthritis

scholarly journals POS0647 EFFICACY, SAFETY AND CHARACTERISTICS OF IGURATIMOD-BASED THERAPY IN THE TREATMENT OF UA, ERA AND RA PATIENTS FOR 24 WEEKS: A PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Adverse Events ◽  
Disease Activity ◽  
Prospective Cohort Study ◽  
Early Rheumatoid Arthritis ◽  
Prospective Cohort ◽  
Combined Treatment ◽  
Serious Adverse Events

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared

scholarly journals Prediction of disease progression in early rheumatoid arthritis by ICTP, RF and CRP. A comparative 3-year follow-up study

Rheumatology ◽  
2000 ◽  
Vol 39 (9) ◽  
pp. 1009-1013 ◽  
Author(s):  
S. Aman ◽  
L. Paimela ◽  
M. Leirisalo-Repo ◽  
J. Risteli ◽  
H. Kautiainen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Progression ◽  
Early Rheumatoid Arthritis ◽  
Follow Up Study

scholarly journals Disability Related to Function of the Upper Extremities in Early Rheumatoid Arthritis – Course and Relation to Other Disease Parameters Over 10 Years: A Cohort Study

2020 ◽  
Author(s):  
MARIA RYDHOLM ◽  
INGEGERD WIKSTROM ◽  
SOFIA HAGEL ◽  
LENNART T.H. JACOBSSON ◽  
CARL TURESSON
Keyword(s):  
Rheumatoid Arthritis ◽  
Early Rheumatoid Arthritis ◽  
Grip Force ◽  
Upper Extremities ◽  
Joint Involvement ◽  
Multivariate Linear Regression Analysis ◽  
Clinical Parameters ◽  
Early Ra ◽  
Disease Parameters

Abstract Background: The objective of this study was to investigate the course of disability related to the upper extremities (UE) in early rheumatoid arthritis (RA), and to assess correlations between such disability and clinical parameters, including grip force. Methods: In an inception cohort of patients with early RA (N=222), disability of the UE was assessed using a subscore of the Health assessment questionnaire disability index (HAQ-DI), and average grip force of the dominant hand was measured. Changes between consecutive follow-up visits in the HAQ-DI-UE subscore were assessed using the paired samples t-test, and correlations with key disease parameters using Spearman’s rank test. The relation between joint involvement and HAQ-DI-UE was examined using multivariate linear regression analysis. Results: The HAQ-DI-UE decreased significantly from inclusion to the 6-month follow-up (mean change -0.26; 95% CI -0.18 to -0.34), and increased significantly after 2 years. There were fairly strong correlations for HAQ-DI-UE with grip force (r: -0.50 to -0.62), patient’s global assessment (r:0.58 to 0.64) and patient’s assessment of pain (r:0.54 to 0.60) at all time points up to 5 years, but only moderate to weak correlations with swollen joints, CRP and ESR. At inclusion wrist synovitis and tender PIP joints had both an independent impact on HAQ-DI-UE, whereas tenderness of the shoulder and the wrist had a greater importance at 6 months. Conclusions: Disability related to the upper extremities decreased significantly during the first 6 months, and increased again after 2 years. The correlations with clinical parameters underline the major impact of pain and impaired hand function in early RA.

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