Endothelial DysfunctionNCT05662891
The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise
A study testing Blood Flow Restriction in people with Endothelial Dysfunction and Hamstring Injury, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of blood flow restriction applied during nordic hamstring exercise on neuromuscular activation and endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Hamstring Injury
- What is being tested?
- Blood Flow Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Oct 2022
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- Having chronic diseases such as coronary heart disease, kidney diseases, diabetes, uncontrollable hypertension
- Having a history of deep vein thrombosis
- Having a previous hamstring injury
- To smoke
- Having a Body Mass Index over 25
- Having a history of major surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise on Neuromuscular Activation and Endothelial Function
The aim of this study is to investigate the effects of blood flow restriction applied during nordic hamstring exercise on neuromuscular activation and endothelial function.
- Conditions
- Endothelial Dysfunction, Hamstring Injury
- Being tested
- Blood Flow Restriction
- Keywords
- blood flow restriction, nordic hamstring exercise, endothelial function, muscular activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionOther
Also called Nordic Hamstring Exercise
After randomization, a cuff was placed proximal to one lower extremity. Blood flow was restricted from 60% of the arterial occlusion pressure. The other extremity was determined as the control group. 3x5 nordic hamstring exercises were performed. Surface emg was measured for hamstring muscles during exercise.
| Study group | Role | What they receive |
|---|---|---|
| blood flow restriction + Nordic hamstring exercise | Experimental | Not described Receives: Other: Blood Flow Restriction |
| Nordic hamstring exercise | Experimental | Not described Receives: Other: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Endothelial function was evaluated with flow-mediated dilation.
Measured: It was evaluated for the control and experimental extremities before exercise.
Surface EMG
It was evaluated for the biceps femoris and semitendinosus muscles of the control and experimental extremities during Nordic hamstring exercise.
Measured: During exercise
Endothelial function
Endothelial function was evaluated with flow-mediated dilation.
Measured: It was evaluated for the control and experimental extremities 15 minutes after exercise. ( Outcomes were evaluated as acute.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- randomized controlled single-blind study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuat YÜKSEL, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662891
- Sponsor's protocol ID
- E-77082166-604.01.02-18938
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2022
- Last updated
- 23 Dec 2022
- 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise on Neuromuscular Activation and Endothelial Function
- ClinicalTrials.gov ID
- NCT05662891
- Acronym / sponsor ID
- E-77082166-604.01.02-18938
- Conditions
- Endothelial Dysfunction, Hamstring Injury
- Keywords
- blood flow restriction, nordic hamstring exercise, endothelial function, muscular activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 23 Dec 2022 (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 this study is to investigate the effects of blood flow restriction applied during nordic hamstring exercise on neuromuscular activation and endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized controlled single-blind study
| Arm | Type | Receives |
|---|---|---|
| blood flow restriction + Nordic hamstring exercise | Experimental | Other: Blood Flow Restriction |
| Nordic hamstring exercise | Experimental | Other: Blood Flow Restriction |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- Having chronic diseases such as coronary heart disease, kidney diseases, diabetes, uncontrollable hypertension
- Having a history of deep vein thrombosis
- Having a previous hamstring injury
- To smoke
- Having a Body Mass Index over 25
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 RestrictionAlso: Nordic Hamstring ExerciseAfter randomization, a cuff was placed proximal to one lower extremity. Blood flow was restricted from 60% of the arterial occlusion pressure. The other extremity was determined as the control group. 3x5 nordic hamstring exercises were performed. Surface emg was measured for hamstring muscles during exercise. | Other | Nordic hamstring exercise, blood flow restriction + Nordic hamstring exercise |
Primary outcome
Endothelial function
Time frame: It was evaluated for the control and experimental extremities before exercise.
Endothelial function was evaluated with flow-mediated dilation.
Surface EMG
Time frame: During exercise
It was evaluated for the biceps femoris and semitendinosus muscles of the control and experimental extremities during Nordic hamstring exercise.
Endothelial function
Time frame: It was evaluated for the control and experimental extremities 15 minutes after exercise. ( Outcomes were evaluated as acute.)
Endothelial function was evaluated with flow-mediated dilation.
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 Dec 2022.
- 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 in people with Endothelial Dysfunction and Hamstring Injury, run by Gazi University at 1 site 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?
The sponsor lists 1 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 23 Dec 2022. 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 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?
Endothelial function (time frame: It was evaluated for the control and experimental extremities before exercise.). The study lists 3 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 23 Dec 2022.