ObjectiveTo determine the effect of a multidisciplinary lifestyle program in patients with RA with low–moderate disease activity.MethodsIn the ‘Plants for Joints’ (PFJ) parallel-arm, assessor-blind randomized controlled trial, patients with RA and 28-joint DAS (DAS28) ≥2.6 and ≤5.1 were randomized to the PFJ or control group. The PFJ group followed a 16-week lifestyle program based on a whole-food plant-based diet, physical activity and stress management. The control group received usual care. Medication was kept stable 3 months before and during the trial whenever possible. We hypothesized that PFJ would lower disease activity (DAS28). Secondary outcomes included anthropometric, metabolic and patient-reported measures. An intention-to-treat analysis with a linear mixed model adjusted for baseline values was used to analyse between-group differences.ResultsOf the 83 people randomized, 77 completed the study. Participants were 92% female with mean (S.D.) age of 55 (12) years, BMI of 26 (4) kg/m2 and mean DAS28 of 3.8 (0.7). After 16 weeks the PFJ group had a mean 0.9-point greater improvement of DAS28 vs the control group (95% CI 0.4, 1.3; P < 0.0001). The PFJ intervention led to greater decreases in body weight (difference –3.9 kg), fat mass (–2.8 kg), waist circumference (–3 cm), HbA1c (–1.3 mmol/mol) and low-density lipoprotein (–0.32 mmol/l), whereas patient-reported outcome measures, blood pressure, glucose and other lipids did not change.ConclusionThe 16-week PFJ multidisciplinary lifestyle program substantially decreased disease activity and improved metabolic status in people with RA with low–moderate disease activity.Trial RegistrationInternational Clinical Trials Registry Platform; https://www.who.int/clinical-trials-registry-platform; NL7800.
To assess the reporting quality of interventions aiming at promoting physical activity (PA) using a wearable activity tracker (WAT) in patients with infammatory arthritis (IA) or hip/knee osteoarthritis (OA). A systematic search was performed in eight databases including PubMed, Embase and Cochrane Library) for studies published between 2000 and 2022. Two reviewers independently selected studies and extracted data on study characteristics and the reporting of the PA intervention using a WAT using the Consensus on Exercise reporting Template (CERT) (12 items) and Consolidated Standards of Reporting Trials (CONSORT) E-Health checklist (16 items). The reporting quality of each study was expressed as a percentage of reported items of the total CERT and CONSORT E-Health (50% or less=poor; 51–79%=moderate; and 80–100%=good reporting quality). Sixteen studies were included; three involved patients with IA and 13 with OA. Reporting quality was poor in 6/16 studies and moderate in 10/16 studies, according to the CERT and poor in 8/16 and moderate in 8/16 studies following the CONSORT E-Health checklist. Poorly reported checklist items included: the description of decision rule(s) for determining progression and the starting level, the number of adverse events and how adherence or fdelity was assessed. In clinical trials on PA interventions using a WAT in patients with IA or OA, the reporting quality of delivery process is moderate to poor. The poor reporting quality of the progression and tailoring of the PA programs makes replication difcult. Improvements in reporting quality are necessary.
Objectives: Improving foot orthoses (FOs) in patients with rheumatoid arthritis (RA) by using in-shoe plantar pressure measurements seems promising. The objectives of this study were to evaluate (1) the outcome on plantar pressure distribution of FOs that were adapted using in-shoe plantar pressure measurements according to a protocol and (2) the protocol feasibility. Methods: Forty-five RA patients with foot problems were included in this observational proof-of concept study. FOs were custom-made by a podiatrist according to usual care. Regions of Interest (ROIs) for plantar pressure reduction were selected. According to a protocol, usual care FOs were evaluated using in-shoe plantar pressure measurements and, if necessary, adapted. Plantar pressure–time integrals at the ROIs were compared between the following conditions: (1) no-FO versus usual care FO and (2) usual care FO versus adapted FO. Semi-structured interviews were held with patients and podiatrists to evaluate the feasibility of the protocol. Results: Adapted FOs were developed in 70% of the patients. In these patients, usual care FOs showed a mean 9% reduction in pressure–time integral at forefoot ROIs compared to no-FOs (p = 0.01). FO adaptation led to an additional mean 3% reduction in pressure–time integral (p = 0.05). The protocol was considered feasible by patients. Podiatrists considered the protocol more useful to achieve individual rather than general treatment goals. A final protocol was proposed. Conclusions: Using in-shoe plantar pressure measurements for adapting foot orthoses for patients with RA leads to a small additional plantar pressure reduction in the forefoot. Further research on the clinical relevance of this outcome is required.
The missing link in diagnostic testing for rheumatoid arthritis (RA) is an agglutination assay, easy to perform and dedicated to decentralized testing. Approximately 75% of RA patients produce autoantibodies to citrullinated proteins (ACPA), which can be detected using an agglutination-based diagnostic test. Such a diagnostic test will be cheaper, less laborious and faster than current tests and does not require sophisticated equipment. Novio Catalpa is developing this alternative test for ACPA in collaboration with Radboud University. To develop this test, specifically tagged and citrullinated nanobodies are needed, but the production is still challenging. Current methods for the production of ACPA diagnostics involve chemical synthesis, in which a variety of toxic chemicals are used in each step. The alternative assay involves nanobodies fused with RA-biomarker target entities, which can be completely produced by ‘green synthesis’ in the yeast Pichia pastoris using the expertise of HAN BioCentre. The yeast P. pastoris has proven to be able to produce nanobodies and is a fast and cost-effective platform that often results in high protein yields. Goal of the project is therefore to determine the feasibility and best green route to produce purified nanobodies tagged with citrullinated ACPA targets that can be used for developing an agglutination assay for RA. P. pastoris does not produce endogenous PAD enzymes which are needed for citrullination of the nanobodies in order to be able to use it in a RA agglutination test. Therefore, PAD enzymes from other sources need to be tested and applied. The project results will be directly used by Novio Catalpa to further develop the innovative test for RA. This project will contribute to and finally result in a single-step agglutination assay suitable for both point-of-care testing and automation in clinical laboratories.
In Europe nearly 10% of the population suffers from diabetes and almost 1% from Rheumatoid Arthritis which can lead to serious problems with mobility and active participation, especially in the ageing population. Pedorthists deliver personalised designed and manufactured orthopaedic footwear or insoles for these patients. However, despite their often laborious efforts upfront, the industry has very little means to quantify how successful the fitting and function of a shoe is. They have to rely on subjective, qualitative measures such as client satisfaction and diminishing of complaints. Although valuable, the need for objective quantitative data in this field is growing. Foot plantar pressure and shear forces are considered major indicators of potential foot problems. Devices to measure plantar pressure slowly gain terrain as providers of objective quantitative data to guide orthotic design and manufacturing. For shear forces however, measuring devices are not yet commercial available. Although shear forces are considered as a major contributor to ulcer formation in diabetic feet, their exact role still requires elucidation and quantification. This project aims to develop a prototype of an in-shoe wearable device that measures both shear forces and pressure using state-of-the-art developments in sensor technologies, smart textiles and wireless data transfer. The collaboration of pedorthists’ small and medium-sized enterprises (SME)’s with medical device engineering companies, knowledge institutes,technical universities and universities of applied sciences in this project will bring together the different fields of expertise required to create an innovative device. It is expected that the tool will be beneficial to improve the quality of pedorthists’ services and potentially reduce health insurance costs. Furthermore, it can be used in new shear forces research and open new business potential. However, the eventual aim is to improve patient care and help maintain personal mobility and participation in society.
