Healthy IndividualsNCT04206345
Acute Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals
A study testing exercise with blood flow restriction and exercise in people with Healthy Individuals, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study is; to investigate the acute effects of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- exercise with blood flow restriction and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 May 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-40
- Do not smoke
- Having full range of motion in neck, shoulder, and elbow
- Body mass index (BMI)˂30 kg/m2
- Able to complete the entire study procedure
Who cannot join
- Having fracture and surgical history for the upper extremity, cervical or thoracic area
- Having any systemic musculoskeletal disease
- Having neck and upper extremity pain
- Having a diagnosis of scoliosis and chest deformity
- Regularly playing sports with overhead activities (tennis, volleyball, handball, etc.)
- Have been exercising regularly for the last 6 months
- A history of anemia
- A history of cerebrovascular disease or myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Exercises Combined With Blood Flow Restriction on Strength, Proprioception and Functional Motor Performance in Healthy Individuals
Purpose of the study is; to investigate the acute effects of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. The investigators hypothesized that blood flow restriction exercises has a positive effect on strength, proprioception and functional motor performance.
Read the detailed description
60 healthy individuals will randomized into 3 groups of 20 people each. Participants will be held in a familiarization session before 3-4 days the actual evaluation. Elbow bending exercises with blood flow restriction will be performed to the blood flow restriction (BFR) group, elbow bending exercises without blood flow restriction will be performed to the exercise group and control group will not receive any interventions. Participants will be evaluated before and after the exercise session. Control group is going to rest for 10 minutes before the second evaluation. Evaluation protocol includes; muscle strength measurement with digital hand dynamometer, shoulder and elbow proprioception evaluation with inclinometer, Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index and Modified Pull-Up Test.
- Conditions
- Healthy Individuals
- Being tested
- exercise with blood flow restriction, exercise
- Keywords
- blood flow restriction, acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise with blood flow restrictionOther
Elbow bending exercises with blood flow restriction will be performed to the exercise group.
exerciseOther
Elbow bending exercises
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Group | Experimental | Elbow bending exercises with resistance exercise band (%20 of 1 maximum repetition) for one session. Blood flow restriction band will be placed during exercise session. The first set of exercises will be 30 repetitions then 3 sets of 15 repetitions. Totally 75 repetitions will be performed. 30 seconds rest interval between sets will be given. Receives: Other: exercise with blood flow restriction |
| Exercise Group | Experimental | Elbow bending exercises with resistance exercise band (%70 of 1 maximum repetition) will be performed for one session. Receives: Other: exercise |
| Control Group | No intervention | 10 minutes resting period will be given between evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Change of biceps muscle strength(in kg, with hand held dynamometer)
Measured: baseline measurements and after 10 minutes of one exercise session
Secondary outcomes (5)
Shoulder proprioception
Change of shoulder proprioception for 100 abduction (with bubble inclinometer)
Measured: baseline measurements and after 10 minutes of one exercise session
Elbow proprioception
change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer)
Measured: baseline measurements and after 10 minutes of one exercise session
Modified Pull-Up Test
Number of pull-ups will be recorded
Measured: baseline measurements and after 10 minutes of one exercise session
Upper Extremity Closed Kinetic Chain Stabilization Test
This test will be occurred in plank position. Participant will touch with one hand to other while maintaining the position. Number of touch will be recorded.
Measured: baseline measurements and after 10 minutes of one exercise session
Functional Throwing Performance Index
Participants will throw a ball to shot a frame on a wall. Number of correct shots will be recorded
Measured: baseline measurements and after 10 minutes of one exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Şahiner Pıçak, Dokuz Eylul University
- Investigators
- Sevgi Yesilyaprak, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206345
- Sponsor's protocol ID
- 2019/18-25
- Status last verified
- Aug 2020
- First submitted
- 20 Nov 2019
- Last updated
- 5 Aug 2020
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Exercises Combined With Blood Flow Restriction on Strength, Proprioception and Functional Motor Performance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04206345
- Acronym / sponsor ID
- 2019/18-25
- Conditions
- Healthy Individuals
- Keywords
- blood flow restriction, acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 20 Dec 2019 (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.
Purpose of the study is; to investigate the acute effects of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. The investigators hypothesized that blood flow restriction exercises has a positive effect on strength, proprioception and functional motor performance.
Detailed description
60 healthy individuals will randomized into 3 groups of 20 people each. Participants will be held in a familiarization session before 3-4 days the actual evaluation. Elbow bending exercises with blood flow restriction will be performed to the blood flow restriction (BFR) group, elbow bending exercises without blood flow restriction will be performed to the exercise group and control group will not receive any interventions. Participants will be evaluated before and after the exercise session. Control group is going to rest for 10 minutes before the second evaluation. Evaluation protocol includes; muscle strength measurement with digital hand dynamometer, shoulder and elbow proprioception evaluation with inclinometer, Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index and Modified Pull-Up Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Group | Experimental | Other: exercise with blood flow restrictionElbow bending exercises with resistance exercise band (%20 of 1 maximum repetition) for one session. Blood flow restriction band will be placed during exercise session. The first set of exercises will be 30 repetitions then 3 sets of 15 repetitions. Totally 75 repetitions will be performed. 30 seconds rest interval between sets will be given. |
| Exercise Group | Experimental | Other: exerciseElbow bending exercises with resistance exercise band (%70 of 1 maximum repetition) will be performed for one session. |
| Control Group | No intervention | –10 minutes resting period will be given between evaluation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-40
- Do not smoke
- Having full range of motion in neck, shoulder, and elbow
- Body mass index (BMI)˂30 kg/m2
- Able to complete the entire study procedure
Key exclusion criteria (8 listed)
- Having fracture and surgical history for the upper extremity, cervical or thoracic area
- Having any systemic musculoskeletal disease
- Having neck and upper extremity pain
- Having a diagnosis of scoliosis and chest deformity
- Regularly playing sports with overhead activities (tennis, volleyball, handball, etc.)
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 |
|---|---|---|
| exercise with blood flow restrictionElbow bending exercises with blood flow restriction will be performed to the exercise group. | Other | Blood Flow Restriction Group |
| exerciseElbow bending exercises | Other | Exercise Group |
Primary outcome
Strength
Time frame: baseline measurements and after 10 minutes of one exercise session
Change of biceps muscle strength(in kg, with hand held dynamometer)
5 secondary outcomes
Shoulder proprioception
Time frame: baseline measurements and after 10 minutes of one exercise session
Elbow proprioception
Time frame: baseline measurements and after 10 minutes of one exercise session
Modified Pull-Up Test
Time frame: baseline measurements and after 10 minutes of one exercise session
Upper Extremity Closed Kinetic Chain Stabilization Test
Time frame: baseline measurements and after 10 minutes of one exercise session
Functional Throwing Performance Index
Time frame: baseline measurements and after 10 minutes of one exercise 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 5 Aug 2020.
- 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.
Sevgi Yesilyaprak principal investigator
Dokuz Eylul 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 exercise with blood flow restriction and exercise in people with Healthy Individuals, run by Dokuz Eylul 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 5 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 5 Aug 2020. 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?
Strength (time frame: baseline measurements and after 10 minutes of one exercise session). 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 5 Aug 2020.