Female Football PlayersNCT06445478
Effectiveness of Blood Flow Restricting Exercises and Isokinetic Exercises in Female Football Players
A study testing Blood Flow Restrictive Exercise and Isokinetic Exercise in people with Female Football Players, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our aim in the study is; Comparison of blood flow restrictive exercises and isokinetic exercises in female football players. 30 female football players between the ages of 18-30 who came to DOIT Health \& Sports clinic to receive rehabilitation will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Football Players
- What is being tested?
- Blood Flow Restrictive Exercise and Isokinetic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2023to 31 Dec 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-30
- Becoming a female football player
- Volunteering to participate in the study
Who cannot join
- Deep vein thrombosis
- Pregnancy
- Hypertension
- Anti-inflammatory use
- Unexplained chest pain
- Congenital heart disease
- Participants with a history of contraindications to exercise
- There is another study conducted at the same time as the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
DOIT Health & Sports Clinic
Istanbul, Ataşehir, 34758
About this study
Official title: Comparison of Blood Flow Restrictive Exercises and Isokinetic Exercises in Female Football Players: Randomized Controlled Study
Our aim in the study is; Comparison of blood flow restrictive exercises and isokinetic exercises in female football players. 30 female football players between the ages of 18-30 who came to DOIT Health \& Sports clinic to receive rehabilitation will be included in the study. Participants will be randomized into 2 groups. Resistant exercise with blood flow restrictive exercise (BFR-RE) will be applied to one group, and resistant exercise with isokinetic device (ID-RE) will be applied to the other group. An 8-week exercise protocol will be created for both groups and exercise training will be given twice a week. Demographic data form, Kineo Intelligent Load Isokinetic Device to measure muscle strength, tape measure to measure circumference, universal goniometer for joint range of motion, Illinois Agility Test for agility and quality of life; World Health Organization Quality of Life Scale-Short Form Turkish Version will be administered before exercise, at the 4th week and at the 8th week. The effectiveness of the applications for female football players and their advantages over each other will be examined. The 4-week and 8-week effects of 2 types of exercise will be examined.
- Conditions
- Female Football Players
- Being tested
- Blood Flow Restrictive Exercise and Isokinetic Exercise
- Keywords
- Resistance exercise, Isokinetic exercise, Female football player, Blood flow restrictive exercise, Athlete rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restrictive Exercise and Isokinetic ExerciseOther
Before providing exercise training, the muscle strength, circumference measurement, joint range of motion, agility and quality of life of female football players will be determined. Muscle strength measurements will be evaluated with the Kineo Intelligent Load Isokinetic Device for the BFR-RE and ID-RE groups. Then, both groups will be given 4 weeks of resistance exercise training. After this training, all evaluations will be made again. After this evaluation, another 4 weeks of training will be given and the evaluations will be re-applied at the end of the 8th week.
The "Informed Volunteer Consent Form" will be read and signed by 30 selected participants.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Resistant exercise with blood flow restrictive exercise (BFR-RE Group )) | Experimental | Resistant exercise with blood flow restrictive exercise (BFR-RE) training will be given 2 days a week for 8 weeks. Each exercise session will consist of 4 sets. There will be 30 repetitions in the first set and 15 repetitions in the next 3 sets, for a total of 75 repetitions. There will be a minimum of 30 seconds and a maximum of 60 seconds of rest intervals between sets. Since the application will be performed for the lower extremity muscle groups, a cuff will be placed on the proximal part of the lower extremity. Exercise load will be determined as 20-40% of 1 RM. Receives: Other: Blood Flow Restrictive Exercise and Isokinetic Exercise |
| Group 2 (Resistant exercise with isokinetic device (ID-RE Group)) | Experimental | Resistant exercise with isokinetic device (ID-RE) training will be given 2 days a week for 8 weeks. During the training, leg press, squat and knee extension movements will be improved by increasing the resistance or changing the position depending on the athlete's condition. Receives: Other: Blood Flow Restrictive Exercise and Isokinetic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kineo Intelligent Load Isokinetic Device
With Kineo, evaluation of lower/upper extremity and trunk muscles can be made. The device can also be used to provide strength training. The isokinetic method is characterized by movement at a predetermined constant speed regardless of the applied force. The test (single or double-sided) includes 5 consecutive movements with different speed and maximum power connection. Analysis of the graph allows evaluation of the relationship between force, velocity and angle. It allows isokinetic exercise to be performed at all workstations, both in the open chain and in the closed chain. Additionally, with Kineo Biphasic Load, it is possible to distinguish the load between concentric and eccentric phases to reduce muscle effort and make the work safer. Detailed reports on strength, muscle imbalances and all data necessary for continuous monitoring of the rehabilitation process are instantly visible, can be printed or exported in Excel format.
Measured: 10 weeks
Thigh and Leg Circumference Measurement
A foldable, non-elastic 7 mm wide tape measure will be used for circumference measurements. The tape measure will not be affected by the tensions during the measurement and the "0" starting part will be in the left hand, the area to be measured with the other hand will be wrapped with the tape measure and the circumference will be measured by placing the "0" point and the measured number side by side rather than on top of each other.
Measured: 10 weeks
Universal Goniometer
Flexion and extension range of motion (ROM) of the knee was measured in degrees (°) using the "Universal Goniometer". Knee ROM was assessed using a goniometer with the participant lying supine with the heel elevated on a foam roller. Knee extension was measured with participants maximally extending the knee joint and was defined as the difference from 0° extension. Knee flexion was measured with patients bending their knees and lifting their heels toward their hips as far as possible. The pivot point of the goniometer was placed on the lateral condyle of the femur, and the fixed arm was placed on the lateral side of the leg in the direction of the midline of the femur, and the measurement was made so that the movable arm followed the movement of the fibula.
Measured: 10 weeks
Illinois Agility Test
It is used to determine the agility of athletes by taking into account their direction changes. Before the test, necessary explanations are made and the track is introduced, then the subjects are allowed to make 3-4 attempts at a low tempo. It is performed on a test track consisting of three cones arranged in a straight line with a width of 5 m, a length of 10 m and 3.3 m intervals in the middle section. The test consists of a slalom run, with 180° turns every 10 m, 40 m on the flat and 20 m between cones. Athletes are asked to start at the starting line of the test track, lying face down and with their hands in contact with the ground at shoulder level. With complete rest, the test is repeated 2 times and the best value is recorded in seconds.
Measured: 10 weeks
World Health Organization Quality of Life Scale - Short Form Turkish Version
The health-related quality of life scale was developed by WHO, and its validity and reliability were tested by Eser et al. The scale has two versions: long (WHOQOL-100) and short (WHOQOL-27) form. The scale measures physical, spiritual, social and environmental well-being and consists of 26 questions. The scale can be applied to non-elderly adults. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start2 Apr 2023
- Primary completion1 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Football PlayersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Sever, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445478
- Sponsor's protocol ID
- İREMNURESMANURRABİA
- Status last verified
- Jun 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Flow Restrictive Exercises and Isokinetic Exercises in Female Football Players: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06445478
- Acronym / sponsor ID
- İREMNURESMANURRABİA
- Conditions
- Female Football Players
- Keywords
- Resistance exercise, Isokinetic exercise, Female football player, Blood flow restrictive exercise, Athlete rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jun 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.
Our aim in the study is; Comparison of blood flow restrictive exercises and isokinetic exercises in female football players. 30 female football players between the ages of 18-30 who came to DOIT Health \& Sports clinic to receive rehabilitation will be included in the study. Participants will be randomized into 2 groups. Resistant exercise with blood flow restrictive exercise (BFR-RE) will be applied to one group, and resistant exercise with isokinetic device (ID-RE) will be applied to the other group. An 8-week exercise protocol will be created for both groups and exercise training will be given twice a week. Demographic data form, Kineo Intelligent Load Isokinetic Device to measure muscle strength, tape measure to measure circumference, universal goniometer for joint range of motion, Illinois Agility Test for agility and quality of life; World Health Organization Quality of Life Scale-Short Form Turkish Version will be administered before exercise, at the 4th week and at the 8th week. The effectiveness of the applications for female football players and their advantages over each other will be examined. The 4-week and 8-week effects of 2 types of exercise will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Resistant exercise with blood flow restrictive exercise (BFR-RE Group )) | Experimental | Other: Blood Flow Restrictive Exercise and Isokinetic ExerciseResistant exercise with blood flow restrictive exercise (BFR-RE) training will be given 2 days a week for 8 weeks. Each exercise session will consist of 4 sets. There will be 30 repetitions in the first set and 15 repetitions in the next 3 sets, for a total of 75 repetitions. There will be a minimum of 30 seconds and a maximum of 60 seconds of rest intervals between sets. Since the application will be performed for the lower extremity muscle groups, a cuff will be placed on the proximal part of the lower extremity. Exercise load will be determined as 20-40% of 1 RM. |
| Group 2 (Resistant exercise with isokinetic device (ID-RE Group)) | Experimental | Other: Blood Flow Restrictive Exercise and Isokinetic ExerciseResistant exercise with isokinetic device (ID-RE) training will be given 2 days a week for 8 weeks. During the training, leg press, squat and knee extension movements will be improved by increasing the resistance or changing the position depending on the athlete's condition. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-30
- Becoming a female football player
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- Deep vein thrombosis
- Pregnancy
- Hypertension
- Anti-inflammatory use
- Unexplained chest pain
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 Restrictive Exercise and Isokinetic ExerciseBefore providing exercise training, the muscle strength, circumference measurement, joint range of motion, agility and quality of life of female football players will be determined. Muscle strength measurements will be evaluated with the Kineo Intelligent Load Isokinetic Device for the BFR-RE and ID-RE groups. Then, both groups will be given 4 weeks of resistance exercise training. After this training, all evaluations will be made again. After this evaluation, another 4 weeks of training will be given and the evaluations will be re-applied at the end of the 8th week. The "Informed Volunteer Consent Form" will be read and signed by 30 selected participants. | Other | Group 1 (Resistant exercise with blood flow restrictive exercise (BFR-RE Group )), Group 2 (Resistant exercise with isokinetic device (ID-RE Group)) |
Primary outcome
Kineo Intelligent Load Isokinetic Device
Time frame: 10 weeks
With Kineo, evaluation of lower/upper extremity and trunk muscles can be made. The device can also be used to provide strength training. The isokinetic method is characterized by movement at a predetermined constant speed regardless of the applied force. The test (single or double-sided) includes 5 consecutive movements with different speed and maximum power connection. Analysis of the graph allows evaluation of the relationship between force, velocity and angle. It allows isokinetic exercise to be performed at all workstations, both in the open chain and in the closed chain. Additionally, with Kineo Biphasic Load, it is possible to distinguish the load between concentric and eccentric phases to reduce muscle effort and make the work safer. Detailed reports on strength, muscle imbalances and all data necessary for continuous monitoring of the rehabilitation process are instantly visible, can be printed or exported in Excel format.
Thigh and Leg Circumference Measurement
Time frame: 10 weeks
A foldable, non-elastic 7 mm wide tape measure will be used for circumference measurements. The tape measure will not be affected by the tensions during the measurement and the "0" starting part will be in the left hand, the area to be measured with the other hand will be wrapped with the tape measure and the circumference will be measured by placing the "0" point and the measured number side by side rather than on top of each other.
Universal Goniometer
Time frame: 10 weeks
Flexion and extension range of motion (ROM) of the knee was measured in degrees (°) using the "Universal Goniometer". Knee ROM was assessed using a goniometer with the participant lying supine with the heel elevated on a foam roller. Knee extension was measured with participants maximally extending the knee joint and was defined as the difference from 0° extension. Knee flexion was measured with patients bending their knees and lifting their heels toward their hips as far as possible. The pivot point of the goniometer was placed on the lateral condyle of the femur, and the fixed arm was placed on the lateral side of the leg in the direction of the midline of the femur, and the measurement was made so that the movable arm followed the movement of the fibula.
Illinois Agility Test
Time frame: 10 weeks
It is used to determine the agility of athletes by taking into account their direction changes. Before the test, necessary explanations are made and the track is introduced, then the subjects are allowed to make 3-4 attempts at a low tempo. It is performed on a test track consisting of three cones arranged in a straight line with a width of 5 m, a length of 10 m and 3.3 m intervals in the middle section. The test consists of a slalom run, with 180° turns every 10 m, 40 m on the flat and 20 m between cones. Athletes are asked to start at the starting line of the test track, lying face down and with their hands in contact with the ground at shoulder level. With complete rest, the test is repeated 2 times and the best value is recorded in seconds.
World Health Organization Quality of Life Scale - Short Form Turkish Version
Time frame: 10 weeks
The health-related quality of life scale was developed by WHO, and its validity and reliability were tested by Eser et al. The scale has two versions: long (WHOQOL-100) and short (WHOQOL-27) form. The scale measures physical, spiritual, social and environmental well-being and consists of 26 questions. The scale can be applied to non-elderly adults. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases.
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 6 Jun 2024.
- 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 Restrictive Exercise and Isokinetic Exercise in people with Female Football Players, run by Istanbul Medipol University Hospital 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 3 inclusion and 8 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 6 Jun 2024. 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?
Kineo Intelligent Load Isokinetic Device (time frame: 10 weeks). The study lists 5 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 6 Jun 2024.