Blood Flow RestrictionNCT06678009
Isokinetic Training Combined with Blood Flow Restriction on Muscle Strength and Endurance
A study testing the isokinetic training group with blood flow restriction and the isokinetic training group without blood flow restriction in people with Blood Flow Restriction, run by Bihter Aslanyurek at 2 sites in Turkey (Türkiye).
Trial summary
Evidence regarding the effectiveness of blood flow restriction during isokinetic exercises is insufficient. When the literature is reviewed, it is seen that there are very few studies investigating the effect of isokinetic training program with blood flow restriction on muscle strength and endurance in healthy… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Blood Flow Restriction
- What is being tested?
- the isokinetic training group with blood flow restriction and the isokinetic training group without blood flow restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Jun 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: the absence of heart disease, arterial hypertension, diabetes mellitus or any musculoskeletal condition of the lower extremities that precluded participation in the recommended training protocols and testing, no use of any dietary supplements during the study and for at least 2 months prior to the study and running more than 20 kilometers per week.
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Exclusion Criteria: Age <20 or >40, history of cardiac disease, history of heart failure, history of coronary artery disease, history of peripheral artery disease, presence/history of varicose veins, history of hypertension, history of diabetes mellitus, history of pulmonary disease, history of pulmonary embolism, history of hematological disease, history of previous deep vein thrombosis, pregnancy, use of oral contraceptives, use of anticoagulants, history of previous surgery in the lower extremity, body mass index >25, history of cancer, presence of lymphedema, history of lymphadenectomy, history of trauma in the lower extremity within the last 6 months or 1 year.
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Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
University of Health Sciences, Gulhane Faculty of Medicine
Ankara, Ankara, 06018
Bihter Akınoğlu
Ankara
About this study
Official title: The Effect of 8-week Isokinetic Training Combined with Blood Flow Restriction on Muscle Strength and Endurance in Runners
Evidence regarding the effectiveness of blood flow restriction during isokinetic exercises is insufficient. When the literature is reviewed, it is seen that there are very few studies investigating the effect of isokinetic training program with blood flow restriction on muscle strength and endurance in healthy athletes. In line with this information, the aim of this study was to investigate the effect of an 8-week isokinetic training program combined with blood flow restriction on knee flexor and extensor maximal muscle strength and endurance in runners.
Read the detailed description
The purpose of this study is to investigate the effect of lower extremity isokinetic training combined with blood flow restriction (BFR) on knee flexor and extensor muscle strength and endurance in runners. A total of 42 runners were randomly assigned to either the isokinetic training group with blood flow restriction (BFR Group; n= 21) or the isokinetic training group without blood flow restriction (Control Group; n= 21). For the BFR, the occlusion pressure was set to 80% of arterial occlusion pressure as determined. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions. The muscle strength and endurance were evaluated before and after the training program using an isokinetic dynamometer.
- Conditions
- Blood Flow Restriction
- Being tested
- the isokinetic training group with blood flow restriction, the isokinetic training group without blood flow restriction
- Keywords
- blood flow restriction (BFR), isokinetic training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the isokinetic training group with blood flow restrictionDevice
The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions.
the isokinetic training group without blood flow restrictionDevice
The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions.
| Study group | Role | What they receive |
|---|---|---|
| The isokinetic training group with blood flow restriction (BFR Group) | Active comparator | For the BFR, the occlusion pressure was set to 80% of arterial occlusion pressure as determined. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions. Receives: Device: the isokinetic training group with blood flow restriction |
| The isokinetic training group without blood flow restriction (Control Group) | Other | The isokinetic training group without blood flow restriction. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions Receives: Device: the isokinetic training group without blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of lower extremity muscle strength and muscular endurance using isokinetic dynamometry in runners who met the inclusion criteria for the study.
Isokinetic knee flexor and extensor muscles strength and endurance were evaluated with the isokinetic dynamometer. All the athletes underwent twice a week for 8 weeks of isokinetic training protocol. Both groups performed the same isokinetic training protocol. Blood flow restriction was applied to the BFR group while the athletes doing isokinetic training protocol, but not to the control group. Isokinetic knee flexor and extensor muscles strength and endurance were re- evaluated at the end of the intervention (48 hours after the last training session).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start15 Jul 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Flow RestrictionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 42 runners were randomly assigned to either the isokinetic training group with blood flow restriction (BFR Group; n= 21) or the isokinetic training group without blood flow restriction (Control Group; n= 21).
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bihter Aslanyurek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bihter Aslanyurek, Ankara Yildirim Beyazıt University
- Investigators
- Yasemin F. Çetinkaya, MD, Study director, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678009
- Sponsor's protocol ID
- Gulhane
- Other IDs
- 321S398
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Supporting information (data) will be shared once it is available for publication.
Publications
Gunaydin H, Akinoglu B, Orscelik A, Asar E, Buyukluoglu G, Kocahan T. Adding blood flow restriction to isokinetic resistance training provides no additional benefit for strength, but may improve local muscular endurance: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Jan 28;18(1):100. doi: 10.1186/s13102-026-01554-7.
PubMed 41593783
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 8-week Isokinetic Training Combined with Blood Flow Restriction on Muscle Strength and Endurance in Runners
- ClinicalTrials.gov ID
- NCT06678009
- Acronym / sponsor ID
- Gulhane
- Conditions
- Blood Flow Restriction
- Keywords
- blood flow restriction (BFR), isokinetic training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bihter AslanyurekUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 7 Nov 2024 (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.
Evidence regarding the effectiveness of blood flow restriction during isokinetic exercises is insufficient. When the literature is reviewed, it is seen that there are very few studies investigating the effect of isokinetic training program with blood flow restriction on muscle strength and endurance in healthy athletes. In line with this information, the aim of this study was to investigate the effect of an 8-week isokinetic training program combined with blood flow restriction on knee flexor and extensor maximal muscle strength and endurance in runners.
Detailed description
The purpose of this study is to investigate the effect of lower extremity isokinetic training combined with blood flow restriction (BFR) on knee flexor and extensor muscle strength and endurance in runners. A total of 42 runners were randomly assigned to either the isokinetic training group with blood flow restriction (BFR Group; n= 21) or the isokinetic training group without blood flow restriction (Control Group; n= 21). For the BFR, the occlusion pressure was set to 80% of arterial occlusion pressure as determined. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions. The muscle strength and endurance were evaluated before and after the training program using an isokinetic dynamometer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 42 runners were randomly assigned to either the isokinetic training group with blood flow restriction (BFR Group; n= 21) or the isokinetic training group without blood flow restriction (Control Group; n= 21).
| Arm | Type | Receives |
|---|---|---|
| The isokinetic training group with blood flow restriction (BFR Group) | Active comparator | Device: the isokinetic training group with blood flow restrictionFor the BFR, the occlusion pressure was set to 80% of arterial occlusion pressure as determined. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions. |
| The isokinetic training group without blood flow restriction (Control Group) | Other | Device: the isokinetic training group without blood flow restrictionThe isokinetic training group without blood flow restriction. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| the isokinetic training group with blood flow restrictionThe isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions. | Device | The isokinetic training group with blood flow restriction (BFR Group) |
| the isokinetic training group without blood flow restrictionThe isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions. | Device | The isokinetic training group without blood flow restriction (Control Group) |
Primary outcome
Evaluation of lower extremity muscle strength and muscular endurance using isokinetic dynamometry in runners who met the inclusion criteria for the study.
Time frame: Baseline and 8 weeks
Isokinetic knee flexor and extensor muscles strength and endurance were evaluated with the isokinetic dynamometer. All the athletes underwent twice a week for 8 weeks of isokinetic training protocol. Both groups performed the same isokinetic training protocol. Blood flow restriction was applied to the BFR group while the athletes doing isokinetic training protocol, but not to the control group. Isokinetic knee flexor and extensor muscles strength and endurance were re- evaluated at the end of the intervention (48 hours after the last training session).
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 7 Nov 2024.
- Derived from this study: PubMed 41593783Gunaydin H, Akinoglu B, Orscelik A, Asar E, Buyukluoglu G, Kocahan T. Adding blood flow restriction to isokinetic resistance training provides no additional benefit for strength, but may improve local muscular endurance: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2026 Jan 28;18(1):100. doi: 10.1186/s13102-026-01554-7.
- Individual participant dataSharing planned: Yes. Supporting information (data) will be shared once it is available for publication.
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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.
Yasemin F. Çetinkaya, MD study director
Gulhane Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the isokinetic training group with blood flow restriction and the isokinetic training group without blood flow restriction in people with Blood Flow Restriction, run by Bihter Aslanyurek at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Evaluation of lower extremity muscle strength and muscular endurance using isokinetic dynamometry in runners who met the inclusion criteria for the study. (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678009, which also lists 1 linked publication.
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 7 Nov 2024.