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NCT Number: NCT07772687

Prospective Analysis of Blood Flow Restriction Training in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Compared to Conventional Strength Training

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bonn, Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology

Bonn, North Rhine-Westphalia, 53127, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • history of deep vein thrombosis or pulmonary artery embolism
  • current use of blood thinners
  • peripheral arterial occlusive disease
  • infection within the last two weeks
  • angina pectoris
  • refusal to give informed consent

Treatment and study plan

Blood Flow Restriction Training (BFRT)

Behavioral

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.

Conventional Strength Training

Behavioral

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.

Primary outcomes

  1. Feasibility (measured by retention rate) of BFRT in Patients with Rheumatoid Arthritis and Psoriatic Arthritis

    Time frame: 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 outcomes

  1. Change in Muscle Diameter

    Time frame: 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.

  2. Change in Body Composition

    Time frame: 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.

  3. Change in Physical Function as Assessed by the Hannover Functional Ability Questionnaire (FFbH)

    Time frame: 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.

  4. Change in Pain Perception as Assessed by the Visual Analogue Scale (VAS)

    Time frame: 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.

  5. Change in Physical Activity Level as Assessed by the International Physical Activity Questionnaire (IPAQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Registry information

Acronym: BFR-RA/PSA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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