Physical PerformanceNCT05225129
Effects Of Blood Flow Restriction Exercise Applications On Physical Fitness Parameters
A study testing blood flow restriction exercise in people with Physical Performance, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Aim: The aim of the study; during the non-race season, blood flow-restricted exercises applied in addition to routine training programs to determine the effects on physical fitness parameters and sportive motivation of male canoe athletes aged 18 and over and to compare the results between the groups. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Performance
- What is being tested?
- blood flow restriction exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCyprus
- Study dates
- 17 Jan 2022to 30 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age or older
- Being a licensed athlete for at least 2 years,
- No history of orthopedic injury in the last 6 months
- Athletes who have been doing resistance exercise for at least 5 years
Who cannot join
- Presence of disease that will cause endothelial dysfunction (hypertension, cardiovascular diseases, neurological diseases, atherosclerosis)
- History of deep vein thrombosis and peripheral vascular disease
- Presence of acute infection
- Cancer cases
- Having undergone a surgical operation due to trauma in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Blood Flow Restriction Exercise Applications On Physical Fitness Parameters and Sporting Motivation in Canoe Athletes
Aim: The aim of the study; during the non-race season, blood flow-restricted exercises applied in addition to routine training programs to determine the effects on physical fitness parameters and sportive motivation of male canoe athletes aged 18 and over and to compare the results between the groups.
Method: Male athletes aged 18 and over who are licensed and actively engaged in canoeing in Turkey will be included in the study. Subjects will be divided into two groups , training and control. The training group will be given blood flow restricted exercise for 8 weeks and resistance training equivalent to 30% of 1 maximum repetition. In the control group, 30% of 1 MT of resistance training will be applied for 8 weeks without blood flow restriction. Before and after, athletes will be evaluated with sport-specific performance tests, muscle thickness measurement with ultrasound, isokinetic measurement of hamstring and quadriceps muscles at a speed of 60°/sec and 300°/sec. In addition, the muscles of the athletes will be evaluated with dynamic muscular measurements.
Read the detailed description
The first evaluation will be made before the 8-week training, and the second evaluation will be made at the end of the 8-week training. Both groups will be re-evaluated for follow-up at 6 and 12 months from the start of the study. In the 4th week, it is aimed to improve the exercise protocols by increasing the number of sets and repetitions in both groups.
The training will start with a 10-minute warm-up exercise on the static bike, and then stretching exercises will be applied. The athlete is dressed in the KAK apparatus and the pressure is given continuously so that it is on the device. In the 30-minute CAC exercise training, the athlete will complete the resistance exercises on the Leg Press, Leg Curl, Leg Calf Raise, Quadriceps Extension machines while attached to the device.
In the exercise prescription, which is planned as 3 sets of 10 repetitions, a rest period of 60 seconds will be given between sets. A 10-minute cool-down period will be added at the end of the training.
- Conditions
- Physical Performance
- Being tested
- blood flow restriction exercise
- Keywords
- blood flow restriction, physical parameters, sporting motivation, canoe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restriction exerciseOther
Also called resistance exercise
blood flow restricted exercise, resistance training will be applied, corresponding to 30% of 1 maximum repetition for 8 weeks, 2 days in a week
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Resistance training will be applied to the training group, equivalent to 30% of 1 maximum repetition with blood flow restricted exercise for 8 weeks , 2 days in a week. Receives: Other: blood flow restriction exercise |
| Control Group | No intervention | Resistance training will be applied to the control group, equivalent to 30% of 1 maximum repetition without blood flow restriction for 8 weeks , 2 days in a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the sportive performance will be measured by ergometer
Indoor ergometer will be used to determine the sportive performance changes of canoe athletes.
Measured: At the beginning and at the end of 8 weeks
Changes in muscle thickness will be measured by ultrasound
The thickness measurements of the Rectus Femoris, Vastus Medialis Obliqus, Vastus Lateralis and Hamstring muscles and the area measurements of the rectus femoris and hamstring muscles will be measured by the sports physician.
Measured: At the beginning and at the end of 8 weeks
Quadriceps and Hamstring muscle strength, endurance, Ham/Quad ratio will be evaluated with an isokinetic dynamometer.
Angular velocities; 60 degrees/sec, 300 degrees/sec will be measured bilaterally with the Biodex System 3. For 60 degrees / sec, the athlete will do 5 repetitions, and for 300 degrees / sec, the athlete will do 15-20 repetitions. Before both measurements, evaluation will begin after 3 rewarmings.
Measured: At the beginning and at the end of 8 weeks
In the Dynamic Measurement of Muscular Strength, a repetitive maximum method is used to measure the force with the dynamic method.
It is performed with an appropriate starting weight close to but below the person's maximal lifting capacity for any muscle group. After the first repetition, the weight is lifted until the maximum lifting force is reached. It determines the maximum weight that athletes can lift at once in normal joint movement.
Measured: At the beginning and at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start17 Jan 2022
- Primary completion22 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Uğur Tosun, Eastern Mediterranean University
- Investigators
- Berkiye Kırmızıgil, Asst. Prof., Study chair, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225129
- Sponsor's protocol ID
- 2021/12/31
- Status last verified
- Dec 2022
- First submitted
- 25 Jan 2022
- Last updated
- 29 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 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Blood Flow Restriction Exercise Applications On Physical Fitness Parameters and Sporting Motivation in Canoe Athletes
- ClinicalTrials.gov ID
- NCT05225129
- Acronym / sponsor ID
- 2021/12/31
- Conditions
- Physical Performance
- Keywords
- blood flow restriction, physical parameters, sporting motivation, canoe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 4 Feb 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.
Aim: The aim of the study; during the non-race season, blood flow-restricted exercises applied in addition to routine training programs to determine the effects on physical fitness parameters and sportive motivation of male canoe athletes aged 18 and over and to compare the results between the groups.
Method: Male athletes aged 18 and over who are licensed and actively engaged in canoeing in Turkey will be included in the study. Subjects will be divided into two groups , training and control. The training group will be given blood flow restricted exercise for 8 weeks and resistance training equivalent to 30% of 1 maximum repetition. In the control group, 30% of 1 MT of resistance training will be applied for 8 weeks without blood flow restriction. Before and after, athletes will be evaluated with sport-specific performance tests, muscle thickness measurement with ultrasound, isokinetic measurement of hamstring and quadriceps muscles at a speed of 60°/sec and 300°/sec. In addition, the muscles of the athletes will be evaluated with dynamic muscular measurements.
Detailed description
The first evaluation will be made before the 8-week training, and the second evaluation will be made at the end of the 8-week training. Both groups will be re-evaluated for follow-up at 6 and 12 months from the start of the study. In the 4th week, it is aimed to improve the exercise protocols by increasing the number of sets and repetitions in both groups.
The training will start with a 10-minute warm-up exercise on the static bike, and then stretching exercises will be applied. The athlete is dressed in the KAK apparatus and the pressure is given continuously so that it is on the device. In the 30-minute CAC exercise training, the athlete will complete the resistance exercises on the Leg Press, Leg Curl, Leg Calf Raise, Quadriceps Extension machines while attached to the device.
In the exercise prescription, which is planned as 3 sets of 10 repetitions, a rest period of 60 seconds will be given between sets. A 10-minute cool-down period will be added at the end of the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: blood flow restriction exerciseResistance training will be applied to the training group, equivalent to 30% of 1 maximum repetition with blood flow restricted exercise for 8 weeks , 2 days in a week. |
| Control Group | No intervention | –Resistance training will be applied to the control group, equivalent to 30% of 1 maximum repetition without blood flow restriction for 8 weeks , 2 days in a week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Being a licensed athlete for at least 2 years,
- No history of orthopedic injury in the last 6 months
- Athletes who have been doing resistance exercise for at least 5 years
Key exclusion criteria (5 listed)
- Presence of disease that will cause endothelial dysfunction (hypertension, cardiovascular diseases, neurological diseases, atherosclerosis)
- History of deep vein thrombosis and peripheral vascular disease
- Presence of acute infection
- Cancer cases
- Having undergone a surgical operation due to trauma in the last 6 months
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 exerciseAlso: resistance exerciseblood flow restricted exercise, resistance training will be applied, corresponding to 30% of 1 maximum repetition for 8 weeks, 2 days in a week | Other | Training Group |
Primary outcome
Changes in the sportive performance will be measured by ergometer
Time frame: At the beginning and at the end of 8 weeks
Indoor ergometer will be used to determine the sportive performance changes of canoe athletes.
Changes in muscle thickness will be measured by ultrasound
Time frame: At the beginning and at the end of 8 weeks
The thickness measurements of the Rectus Femoris, Vastus Medialis Obliqus, Vastus Lateralis and Hamstring muscles and the area measurements of the rectus femoris and hamstring muscles will be measured by the sports physician.
Quadriceps and Hamstring muscle strength, endurance, Ham/Quad ratio will be evaluated with an isokinetic dynamometer.
Time frame: At the beginning and at the end of 8 weeks
Angular velocities; 60 degrees/sec, 300 degrees/sec will be measured bilaterally with the Biodex System 3. For 60 degrees / sec, the athlete will do 5 repetitions, and for 300 degrees / sec, the athlete will do 15-20 repetitions. Before both measurements, evaluation will begin after 3 rewarmings.
In the Dynamic Measurement of Muscular Strength, a repetitive maximum method is used to measure the force with the dynamic method.
Time frame: At the beginning and at the end of 8 weeks
It is performed with an appropriate starting weight close to but below the person's maximal lifting capacity for any muscle group. After the first repetition, the weight is lifted until the maximum lifting force is reached. It determines the maximum weight that athletes can lift at once in normal joint movement.
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 29 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.
Berkiye Kırmızıgil, Asst. Prof. study chair
Eastern Mediterranean University
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 exercise in people with Physical Performance, run by Eastern Mediterranean University at 1 site in Cyprus.
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 5 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 29 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 Cyprus. 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?
Changes in the sportive performance will be measured by ergometer (time frame: At the beginning and at the end of 8 weeks). The study lists 4 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 29 Dec 2022.