Total Knee AnthroplastyNCT07611526
Investigation of the Individual Fatigue Response During Blood Flow Restriction Training
A study testing Cycling BFR in people with Total Knee Anthroplasty, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The aim of the present pilot study is to investigate the feasibility of an exercise pressure response approach for assessing physiological strain during BFR training in a clinically supervised setting. Patients undergoing rehabilitation following total knee arthroplasty (TKA) will be included. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Anthroplasty
- What is being tested?
- Cycling BFR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jun 2026to 22 Oct 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective TKA caused by osteoarthritis of the knee
- Ability to perform cycling exercise
- Participant of the Rehab center
Who cannot join
- Open Wounds
- Iatrogenic Vessel Changes (e.g. Bypasses, Stenting)
- Sickle Cell Anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Individual Fatigue Response During Blood Flow Restriction Training on a Cycle Ergometer Following Orthopedic Surgical Interventions
The aim of the present pilot study is to investigate the feasibility of an exercise pressure response approach for assessing physiological strain during BFR training in a clinically supervised setting. Patients undergoing rehabilitation following total knee arthroplasty (TKA) will be included. The results are intended to contribute to an improved evaluation of load management during BFR training.
- Conditions
- Total Knee Anthroplasty
- Being tested
- Cycling BFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling BFRDevice
Cycling ergometer with blood flow restriction
| Study group | Role | What they receive |
|---|---|---|
| Low Load | Experimental | Low Load (LL-BFR) The first group will perform cycle ergometer training with BFR at a low individual intensity (40% of heart rate reserve [HRR]) as the first session. One week later, the patients will complete the second exercise session using the protocol of the "HL-BFR" group. Receives: Device: Cycling BFR |
| High Load | Experimental | High Load (HL-BFR) The second group will perform cycle ergometer training with BFR at a higher individual intensity (60% of heart rate reserve [HRR]) as the first session. One week later, the patients will complete the second exercise session using the protocol of the "LL-BFR" group. Receives: Device: Cycling BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Pressure Response
Arterial Pulsation Pressure (mmHg) Assessed Continuously During Blood Flow Restriction Training
Measured: Baseline, continuous analysis throughout the entire training session until immediately after it ends (post-workout)
Secondary outcomes (1)
Muscle Strength [1RM]
Quadriceps Isometric Maximal Strength Assessed by Instrumented Leg Press Dynamometry
Measured: Baseline- vs. immediately after the exercise (Pre-Post-Comparison)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start26 Jun 2026
- Primary completion22 Oct 2026
- Study completion22 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 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
- NCT07611526
- Sponsor's protocol ID
- 2026_A
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Individual Fatigue Response During Blood Flow Restriction Training on a Cycle Ergometer Following Orthopedic Surgical Interventions
- ClinicalTrials.gov ID
- NCT07611526
- Acronym / sponsor ID
- 2026_A
- Conditions
- Total Knee Anthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 22 Oct 2026 (actual)
- Study completion
- 22 Oct 2026 (actual)
- First posted
- 28 May 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.
The aim of the present pilot study is to investigate the feasibility of an exercise pressure response approach for assessing physiological strain during BFR training in a clinically supervised setting. Patients undergoing rehabilitation following total knee arthroplasty (TKA) will be included. The results are intended to contribute to an improved evaluation of load management during BFR training.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Load | Experimental | Device: Cycling BFRLow Load (LL-BFR) The first group will perform cycle ergometer training with BFR at a low individual intensity (40% of heart rate reserve [HRR]) as the first session. One week later, the patients will complete the second exercise session using the protocol of the "HL-BFR" group. |
| High Load | Experimental | Device: Cycling BFRHigh Load (HL-BFR) The second group will perform cycle ergometer training with BFR at a higher individual intensity (60% of heart rate reserve [HRR]) as the first session. One week later, the patients will complete the second exercise session using the protocol of the "LL-BFR" group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective TKA caused by osteoarthritis of the knee
- Ability to perform cycling exercise
- Participant of the Rehab center
Key exclusion criteria (3 listed)
- Open Wounds
- Iatrogenic Vessel Changes (e.g. Bypasses, Stenting)
- Sickle Cell Anemia
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 |
|---|---|---|
| Cycling BFRCycling ergometer with blood flow restriction | Device | High Load, Low Load |
Primary outcome
Exercise Pressure Response
Time frame: Baseline, continuous analysis throughout the entire training session until immediately after it ends (post-workout)
Arterial Pulsation Pressure (mmHg) Assessed Continuously During Blood Flow Restriction Training
1 secondary outcome
Muscle Strength [1RM]
Time frame: Baseline- vs. immediately after the exercise (Pre-Post-Comparison)
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 23 Oct 2026.
- 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 Cycling BFR in people with Total Knee Anthroplasty, 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 23 Oct 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?
Exercise Pressure Response (time frame: Baseline, continuous analysis throughout the entire training session until immediately after it ends (post-workout)). 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 23 Oct 2026.