Osteoarthritis (OA) of the KneeNCT06942065
Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty
A study testing Blood Flow Restriction Training in people with Osteoarthritis (OA) of the Knee and Muscle Atrophy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Muscle Atrophy
- What is being tested?
- Blood Flow Restriction Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to 1 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical Fitness for Rehabilitation
- Primary TKA surgery
- BMI < 35
Who cannot join
- Sickle Cell Anemia
- Vascular Intervention on the lower extremities
- Open Wounds
Trial locations and contacts
1 site in 1 country.
About this study
The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty
Read the detailed description
The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.
- Conditions
- Osteoarthritis (OA) of the Knee, Muscle Atrophy
- Being tested
- Sham-BFR, Blood Flow Restriction Training
- Medical subject headings
- Osteoarthritis, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-BFRProcedure or surgery
The exercise protocol for the operated leg (with sham pressure of 20mmHg) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.
Blood Flow Restriction TrainingProcedure or surgery
The exercise protocol for the operated leg (with a BFR pressure of 60% of the LOP) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Control sham condition which performed the exercise with a fixed pressure of 20mmHg Receives: Procedure: Sham-BFR |
| Blood Flow Restriction Group | Experimental | This intervention groups performed training on the operated limb with a BFR pressure corresponding to 60% of the individual limb occlusion pressure Receives: Procedure: Blood Flow Restriction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative Pain was assessed by visual analoge scale (0-100mm)
Measured: Pre- to 6 weeks Post Rehabilitation
Muscle Strength
Isometric muscle strength was measured on a DDRobotec (Dynamic Devices AG, Zurich, Switzerland), a pneumatic, computer-controlled leg press
Measured: Pre- to 6 weeks Post Rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2023
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942065
- Sponsor's protocol ID
- 2023_E
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06942065
- Acronym / sponsor ID
- 2023_E
- Conditions
- Osteoarthritis (OA) of the Knee, Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 24 Apr 2025 (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.
The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty
Detailed description
The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Procedure: Sham-BFRControl sham condition which performed the exercise with a fixed pressure of 20mmHg |
| Blood Flow Restriction Group | Experimental | Procedure: Blood Flow Restriction TrainingThis intervention groups performed training on the operated limb with a BFR pressure corresponding to 60% of the individual limb occlusion pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physical Fitness for Rehabilitation
- Primary TKA surgery
- BMI < 35
Key exclusion criteria (3 listed)
- Sickle Cell Anemia
- Vascular Intervention on the lower extremities
- Open Wounds
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 |
|---|---|---|
| Sham-BFRThe exercise protocol for the operated leg (with sham pressure of 20mmHg) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation. | Procedure or surgery | Control Group |
| Blood Flow Restriction TrainingThe exercise protocol for the operated leg (with a BFR pressure of 60% of the LOP) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation. | Procedure or surgery | Blood Flow Restriction Group |
Primary outcome
Postoperative Pain
Time frame: Pre- to 6 weeks Post Rehabilitation
Postoperative Pain was assessed by visual analoge scale (0-100mm)
Muscle Strength
Time frame: Pre- to 6 weeks Post Rehabilitation
Isometric muscle strength was measured on a DDRobotec (Dynamic Devices AG, Zurich, Switzerland), a pneumatic, computer-controlled leg press
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 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Osteoarthritis (OA) of the Knee and Muscle Atrophy, run by University Hospital, 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 3 inclusion and 3 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 24 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Postoperative Pain (time frame: Pre- to 6 weeks Post Rehabilitation). The study lists 2 primary outcomes in all. 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 24 Apr 2025.