Rheumatoid ArthritisBFR-RA/PSANCT07772687
Prospective Analysis of Blood Flow Restriction Training in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Compared to Conventional Strength Training
A study testing Blood Flow Restriction Training (BFRT) and Conventional Strength Training in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- What is being tested?
- Blood Flow Restriction Training (BFRT) and Conventional Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Bonn, Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology
Bonn, North Rhine-Westphalia, 53127
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Being tested
- Blood Flow Restriction Training (BFRT), Conventional Strength Training
- 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
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Training (BFRT)Behavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment at baseline to the end of the intervention after a 12 week-intervention phase
Secondary outcomes (5)
Change in Muscle Diameter
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.
Measured: Baseline and 12 weeks (post-intervention)
Change in Body Composition
Body composition, specifically muscle mass and fat mass, will be evaluated using bioelectrical impedance analysis (BIA) to determine changes due to the training interventions.
Measured: Baseline and 12 weeks (post-intervention)
Change in Physical Function as Assessed by the Hannover Functional Ability Questionnaire (FFbH)
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.
Measured: Baseline and 12 weeks (post-intervention)
Change in Pain Perception as Assessed by the Visual Analogue Scale (VAS)
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.
Measured: 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)
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.
Measured: Baseline and 12 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start18 Jun 2022
- Primary completion25 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentin Schäfer, University Hospital, Bonn
- Investigators
- Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr., Principal investigator, University Hospital of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772687
- Sponsor's protocol ID
- 217/20
- Acronym
- BFR-RA/PSA
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Blood Flow Restriction Training in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Compared to Conventional Strength Training
- ClinicalTrials.gov ID
- NCT07772687
- Acronym / sponsor ID
- BFR-RA/PSA / 217/20
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Training (BFRT) Group | Experimental | Behavioral: Blood Flow Restriction Training (BFRT)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. |
| Conventional Strength Training Group | Active comparator | Behavioral: Conventional Strength TrainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood 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. | Behavioural | Blood Flow Restriction Training (BFRT) Group |
| Conventional Strength TrainingThis 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. | Behavioural | Conventional Strength Training Group |
Primary outcome
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.
5 secondary outcomes
Change in Muscle Diameter
Time frame: Baseline and 12 weeks (post-intervention)
Change in Body Composition
Time frame: Baseline and 12 weeks (post-intervention)
Change in Physical Function as Assessed by the Hannover Functional Ability Questionnaire (FFbH)
Time frame: Baseline and 12 weeks (post-intervention)
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)
Change in Physical Activity Level as Assessed by the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline and 12 weeks (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr. principal investigator
University Hospital of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training (BFRT) and Conventional Strength Training in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.