Healthy IndividualsNCT03401567
Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals
A study testing Exercise group 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 effect 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 group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2018to 19 Nov 2019
- 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: Effects of Exercises Combined With Blood Flow Restriction on Strength, Joint Position Sense and Functional Motor Performance in Healthy Individuals
Purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. There is no randomized controlled study of the effect of upper extremity exercises performed by restricting blood flow on the joint sensation of individuals and functional motor performance in healthy individuals. For this reason, purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. Pain intensity with the numerical pain rating scale (NRS), muscle strength with digital hand dynamometer, shoulder and elbow proprioception with inclinometer, functional motor performance with Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index, Single Arm Shot Put Test, Modified Pull-Up Test evaluation of 60 healthy individuals without neck and upper extremity pain, the fracture and surgical history for the upper extremity, cervical and thoracic area that prevent them to participate in the study will be made. Participants will randomly be separated into 2 groups of 30 people each. Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week accompanied by a physiotherapist. Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries. Evaluations will be repeated 2 times and analyzed before the treatment and at the end of the 6th week. With the project, the investigators aim to improve the strength, improve proprioception and functional motor performance in healthy individuals by performing exercises restricting blood flow. With the achievement of the targets, exercises combined with blood flow restriction can be considered among the treatments protective for injuries, healing proprioception. The investigators also believe that the project will blaze the trail for the studies to be performed on athletes.
Read the detailed description
Purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. In recent years, the prevalent blood flow restricting exercises seem to favor the development of skeletal muscles in different populations. Studies show that muscular hypertrophy can be achieved also with low-intensity resistance exercises by restricting blood flow. Moreover, exercises combined with blood flow restriction with low mechanical stress and minimal muscle damage do not require a long regeneration process. In this regard, it is stated that the blood flow restricting exercises have lower risk of injuries than the high intensity resistant exercises. It has been shown that similar positive results can be obtained with low-intensity resistance exercises performed by restricting blood flow with classical strengthening exercises performed without limiting in the muscle cross section area. In addition to strength, proprioception and neuromuscular control is important in individuals' therapeutic benefit rates, skills and functionalities, in returning to sports after sports injuries. The investigators believe that classical strengthening exercises may be a contribution to proprioception and consequently to functional motor performance because of the contribution to the proprioception, the low intensity resistant exercise technique performed by restricting blood flow, as well as providing similar muscle growth muscle growth, being painless and harmless to the musculoskeletal system. In this regard, there is no randomized controlled study of the effect of upper extremity exercises performed by restricting blood flow on the joint sensation of individuals and functional motor performance in healthy individuals. For this reason, purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. Pain intensity with the numerical pain rating scale (NRS), muscle strength with digital hand dynamometer, shoulder and elbow proprioception with inclinometer, functional motor performance with Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index, Single Arm Shot Put Test, Modified Pull-Up Test evaluation of 60 healthy individuals without neck and upper extremity pain, the fracture and surgical history for the upper extremity, cervical and thoracic area that prevent them to participate in the study will be made. Participants will randomly be separated into 2 groups of 30 people each. Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week accompanied by a physiotherapist. Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries. Evaluations will be repeated 2 times and analyzed before the treatment and at the end of the 6th week. With the project, the investigators aim to improve the strength, proprioception and functional motor performance in healthy individuals by performing exercises restricting blood flow. With the achievement of the targets, exercises combined with blood flow restriction can be considered among the treatments protective for injuries, healing proprioception. The investigators also believe that the project will blaze the trail for the studies to be performed on athletes.
- Conditions
- Healthy Individuals
- Being tested
- Exercise group
- Keywords
- blood flow restriction, proprioception, functional performance, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupOther
Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week. 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Elbow bending exercises with blood flow restriction will be performed to the exercise group. Receives: Other: Exercise group |
| Control group | No intervention | Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Change of biceps and triceps muscles strength(in kg, with hand held dynamometer)
Measured: Baseline and 6 weeks later
Secondary outcomes (6)
Shoulder proprioception
Change of shoulder proprioception for three direction: 75 external rotation, 45 internal rotation and 100 abduction (with bubble inclinometer)
Measured: Baseline and 6 weeks later
Elbow proprioception
Change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer)
Measured: Baseline and 6 weeks later
Functional motor performance
Determine the performance with Upper Extremity Closed Kinetic Chain Stabilization Test (number of touch)
Measured: Baseline and 6 weeks later
Functional motor performance
Determine the performance with Functional Throwing Performance Index (number of correct shots)
Measured: Baseline and 6 weeks later
Functional motor performance
Determine the performance with Single Arm Shot Put Test (distance measurement in cm),
Measured: Baseline and 6 weeks later
Functional motor performance
Determine the performance with Modified Pull-Up Test (number of pulls)
Measured: Baseline and 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start18 Apr 2018
- Primary completion20 Dec 2018
- Study completion19 Nov 2019
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups of 30 people each. Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week. Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Dere Arasan, Dokuz Eylul University
- Investigators
- Sevgi Sevi YESILYAPRAK, PhD, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401567
- Sponsor's protocol ID
- 3408-GOA
- Status last verified
- Dec 2017
- First submitted
- 23 Dec 2017
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yesilyaprak SS, Dere D. Elbow flexion training with blood flow restriction improves strength, proprioception, and performance in healthy individuals: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Oct 16;26(1):976. doi: 10.1186/s12891-025-08768-9.
PubMed 41102692
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercises Combined With Blood Flow Restriction on Strength, Joint Position Sense and Functional Motor Performance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03401567
- Acronym / sponsor ID
- 3408-GOA
- Conditions
- Healthy Individuals
- Keywords
- blood flow restriction, proprioception, functional performance, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 17 Jan 2018 (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 effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. There is no randomized controlled study of the effect of upper extremity exercises performed by restricting blood flow on the joint sensation of individuals and functional motor performance in healthy individuals. For this reason, purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. Pain intensity with the numerical pain rating scale (NRS), muscle strength with digital hand dynamometer, shoulder and elbow proprioception with inclinometer, functional motor performance with Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index, Single Arm Shot Put Test, Modified Pull-Up Test evaluation of 60 healthy individuals without neck and upper extremity pain, the fracture and surgical history for the upper extremity, cervical and thoracic area that prevent them to participate in the study will be made. Participants will randomly be separated into 2 groups of 30 people each. Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week accompanied by a physiotherapist. Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries. Evaluations will be repeated 2 times and analyzed before the treatment and at the end of the 6th week. With the project, the investigators aim to improve the strength, improve proprioception and functional motor performance in healthy individuals by performing exercises restricting blood flow. With the achievement of the targets, exercises combined with blood flow restriction can be considered among the treatments protective for injuries, healing proprioception. The investigators also believe that the project will blaze the trail for the studies to be performed on athletes.
Detailed description
Purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. In recent years, the prevalent blood flow restricting exercises seem to favor the development of skeletal muscles in different populations. Studies show that muscular hypertrophy can be achieved also with low-intensity resistance exercises by restricting blood flow. Moreover, exercises combined with blood flow restriction with low mechanical stress and minimal muscle damage do not require a long regeneration process. In this regard, it is stated that the blood flow restricting exercises have lower risk of injuries than the high intensity resistant exercises. It has been shown that similar positive results can be obtained with low-intensity resistance exercises performed by restricting blood flow with classical strengthening exercises performed without limiting in the muscle cross section area. In addition to strength, proprioception and neuromuscular control is important in individuals' therapeutic benefit rates, skills and functionalities, in returning to sports after sports injuries. The investigators believe that classical strengthening exercises may be a contribution to proprioception and consequently to functional motor performance because of the contribution to the proprioception, the low intensity resistant exercise technique performed by restricting blood flow, as well as providing similar muscle growth muscle growth, being painless and harmless to the musculoskeletal system. In this regard, there is no randomized controlled study of the effect of upper extremity exercises performed by restricting blood flow on the joint sensation of individuals and functional motor performance in healthy individuals. For this reason, purpose of the study is; to investigate the effect of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. Pain intensity with the numerical pain rating scale (NRS), muscle strength with digital hand dynamometer, shoulder and elbow proprioception with inclinometer, functional motor performance with Upper Extremity Closed Kinetic Chain Stabilization Test, Functional Throwing Performance Index, Single Arm Shot Put Test, Modified Pull-Up Test evaluation of 60 healthy individuals without neck and upper extremity pain, the fracture and surgical history for the upper extremity, cervical and thoracic area that prevent them to participate in the study will be made. Participants will randomly be separated into 2 groups of 30 people each. Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week accompanied by a physiotherapist. Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries. Evaluations will be repeated 2 times and analyzed before the treatment and at the end of the 6th week. With the project, the investigators aim to improve the strength, proprioception and functional motor performance in healthy individuals by performing exercises restricting blood flow. With the achievement of the targets, exercises combined with blood flow restriction can be considered among the treatments protective for injuries, healing proprioception. The investigators also believe that the project will blaze the trail for the studies to be performed on athletes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are 2 groups of 30 people each. Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week. Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise groupElbow bending exercises with blood flow restriction will be performed to the exercise group. |
| Control group | No intervention | –Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries. |
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 groupElbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week. 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. | Other | Exercise group |
Primary outcome
Strength
Time frame: Baseline and 6 weeks later
Change of biceps and triceps muscles strength(in kg, with hand held dynamometer)
6 secondary outcomes
Shoulder proprioception
Time frame: Baseline and 6 weeks later
Elbow proprioception
Time frame: Baseline and 6 weeks later
Functional motor performance
Time frame: Baseline and 6 weeks later
Functional motor performance
Time frame: Baseline and 6 weeks later
Functional motor performance
Time frame: Baseline and 6 weeks later
Functional motor performance
Time frame: Baseline and 6 weeks later
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 21 Nov 2019.
- Derived from this study: PubMed 41102692Yesilyaprak SS, Dere D. Elbow flexion training with blood flow restriction improves strength, proprioception, and performance in healthy individuals: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Oct 16;26(1):976. doi: 10.1186/s12891-025-08768-9.
- 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 Sevi YESILYAPRAK, PhD study director
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 group 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 21 Nov 2019. 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 and 6 weeks later). 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 NCT03401567, 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 21 Nov 2019.