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

NCT07772687 | Completed

• 1 other identifier: 217/20
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment at baseline to the end of the intervention after a 12 week-intervention phase

Secondary Outcomes (5)

• Change in Muscle Diameter

  Baseline and 12 weeks (post-intervention)

• Change in Body Composition

  Baseline and 12 weeks (post-intervention)

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

  Baseline and 12 weeks (post-intervention)

• 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)

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

  Baseline and 12 weeks (post-intervention)

Study Arms (3)

Blood Flow Restriction Training (BFRT) Group

EXPERIMENTAL

Participants in this group will undergo Blood Flow Restriction Training (BFRT) for 12 weeks. The training involves the use of pressure cuffs applied to the limbs to restrict venous return while allowing arterial flow, creating a modulated hypoxic environment in the muscles. Low-intensity resistance exercises will be performed twice a week under supervision, with minimal external weight (1-2 kg) to reduce joint strain. The aim is to assess the effects of BFRT on muscle hypertrophy, strength, pain perception, and overall physical function in patients with rheumatoid arthritis and psoriatic arthritis.

Behavioral: Blood Flow Restriction Training (BFRT)

Conventional Strength Training Group

ACTIVE COMPARATOR

Participants in this group will perform conventional strength training for 12 weeks, engaging in typical high-intensity resistance exercises aimed at increasing muscle strength and mass. Training will take place twice a week under supervision, focusing on exercises that target major muscle groups. This group serves as an active comparator to evaluate the effects of conventional strength training on pain, muscle function, and overall quality of life in comparison to the BFRT group.

Behavioral: Conventional Strength Training

No Intervention Control Group

NO INTERVENTION

Participants in this group will not undergo any specific training intervention for the duration of the study. They will serve as a control group to compare the natural progression of muscle strength, pain levels, and physical function without intervention. The goal is to observe how the absence of training influences the disease outcomes in patients with rheumatoid arthritis and psoriatic arthritis over the 12-week period.

Interventions

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.

Blood Flow Restriction Training (BFRT) Group

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.

Conventional Strength Training Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA)

You may not qualify if:

• age 18 years or older
• signed informed consent form
• 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

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (1)

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

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.

  University Hospital of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. MuDr.

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 19, 2026
• Study Start: June 18, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 31, 2024
• Last Updated: August 19, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)