Rheumatoid Arthritis, Psoriatic Arthritis
Conditions
Keywords
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Inflammatory Joint Disease, Blood Flow Restriction Training (BFRT), Bioelectrical Impedance Analysis, Ultrasound, Exercise Therapy, Inflammatory Disorders, Low-Intensity Resistance Training, Arthritis Management, Disease Activity Monitoring, Rheumatology
Brief summary
This single-centre, randomized prospective interventional study assesses the effect of blood flow restriction training in patients with rheumatoid arthritis compared with conventional resistance training. In this prospective pilot study, patients with RA and PsA will be randomized to one of three groups: Kaatsu BFR training, conventional resistance training, or a non-training control group. The training intervention will be performed twice weekly over a 12-week period. Disease activity will be assessed before and after the (non-)training period using the DAS28, PsAID12, Tender Joint Count, Swollen Joint Count, FFB-H-P and IPAQ questionnaires, clinical examination, and C-reactive protein (CRP) levels. In addition, muscle diemeters will be assessed by ultrasound, while body measurements, bioelectrical impedance analysis, and cytokine and myokine levels will also be determined at both time points.
Detailed description
This single-centre, randomized prospective interventional study is being conducted under the leadership of Dr. Valentin S. Schäfer, Head of Rheumatology and Clinical Immunology and Claus-Juergen Bauer, Deputy Head of Rheumatology and Clinical Immunology at the University Hospital Bonn, and assesses the effect of blood flow restriction training in patients with rheumatoid arthritis compared with conventional resistance training. In this prospective pilot study, patients with RA and PsA will be randomized to one of three groups: Kaatsu BFR training, conventional resistance training, or a non-training control group. The training intervention will be performed twice weekly over a 12-week period. Disease activity will be assessed before and after the (non-)training period using the DAS28, PsAID12, Tender Joint Count, Swollen Joint Count, FFB-H-P and IPAQ questionnaires, clinical examination, and C-reactive protein (CRP) levels. In addition, muscle diemeters will be assessed by ultrasound, while body measurements, bioelectrical impedance analysis, and cytokine and myokine levels will also be determined at both time points.
Interventions
BEHAVIORALBlood Flow Restriction Training (BFRT)
This intervention utilizes specialized pressure cuffs to modulate and partially restrict blood flow during exercise. The technique aims to simulate the effects of high-intensity strength training while using low external loads. The cuffs will be adjusted to specific pressure levels suitable for both upper and lower limbs to ensure optimal safety and effectiveness. The primary goal is to improve muscle function and hypertrophy with minimal joint stress in patients with arthritis.
BEHAVIORALConventional Strength Training
This intervention involves traditional resistance exercises using progressively increasing weights to achieve muscle strengthening. Participants will engage in exercises targeting major muscle groups under supervised conditions, following standard strength training protocols for arthritis patients to avoid overloading the joints.
Sponsors
University of Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study does not use masking, as both the participants and the care providers are aware of the assigned interventions. Intervention assignment is determined by randomization. The nature of the interventions (Blood Flow Restriction Training, conventional resistance training, or no intervention) makes blinding impractical. Outcome assessments are conducted using objective measures, minimizing potential bias.
Intervention model description
This study uses a parallel design where participants are randomized into three distinct groups: (1) an intervention group performing Blood Flow Restriction Training (BFRT), (2) a second intervention group performing conventional strength training, and (3) a non-intervention control group. The groups will be studied simultaneously over a 12-week period, with outcomes assessed at the end of the intervention. This design allows for direct comparison of the effects of BFRT versus conventional resistance training and no training on patients with rheumatoid arthritis and psoriatic arthritis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) * none of the
Exclusion criteria
listed below * age 18 years or older * signed informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (measured by retention rate) of BFRT in Patients with Rheumatoid Arthritis and Psoriatic Arthritis | From enrollment at baseline to the end of the intervention after a 12 week-intervention phase | This study is the first worldwide to investigate the feasibility and effects of Kaatsu blood flow restriction (BFR) training compared with conventional resistance training and no training in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Primary outcome measure to define "feasibility" will be the retention rate in this study. It is defined as the proportion of enrolled participants completing all training visits plus assessments before and after the training phase (as specified by the study protocol) divided by the number enrolled, expressed as a percentage. Retention Rate in both training groups will be compared. Kaatsu blood flow restriction (BFR) training will be considered feasible as long as the training is not statistically significantly inferior to conventional resistance training in terms of its retention rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Diameter | Baseline and 12 weeks (post-intervention) | Among secondary study outcome measures is the change in muscle diameter of the biceps brachii, triceps brachii, quadriceps femoris, and biceps femoris caput longum. Measurements will be taken using ultrasound imaging to assess muscle growth. Muscle diameter measurements will be evaluated at baseline (before the intervention) and after 12 weeks of training to determine the effect of Blood Flow Restriction Training (BFRT) compared to conventional strength training and no intervention. |
| Change in Body Composition | Baseline and 12 weeks (post-intervention) | Body composition, specifically muscle mass and fat mass, will be evaluated using bioelectrical impedance analysis (BIA) to determine changes due to the training interventions. |
| Change in Physical Function as Assessed by the Hannover Functional Ability Questionnaire (FFbH) | Baseline and 12 weeks (post-intervention) | Physical function will be assessed using the FFbH (Funktionsfragebogen Hannover), a validated self-report questionnaire yielding a percentage score of functional ability (0-100%, with higher scores indicating better function). Change from baseline will be compared between the BFR training, conventional resistance training, and no-intervention groups. |
| Change in Pain Perception as Assessed by the Visual Analogue Scale (VAS) | Baseline, at each training session throughout the 12-week intervention, and at 12 weeks (post-intervention) | Pain intensity will be assessed using the Visual Analogue Scale (VAS), a self-reported measure ranging from 0% to 100%, with higher scores indicating greater (worse) pain. Participants will mark their perceived pain on a paper-based VAS at each training session; markings will subsequently be measured and converted to a 0-100% score. Change in VAS score will be compared between the BFR training, conventional resistance training, and no-intervention groups. |
| Change in Physical Activity Level as Assessed by the International Physical Activity Questionnaire (IPAQ) | Baseline and 12 weeks (post-intervention) | Physical activity will be assessed using the IPAQ, which yields total physical activity expressed in MET-minutes/week. Change from baseline will be compared between the BFR training, conventional resistance training, and no-intervention groups. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORValentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.
University Hospital of Bonn
Outcome results
None listed