- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206345
Acute Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals
August 4, 2020 updated by: Gonca Şahiner Pıçak, Dokuz Eylul University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Select State
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İzmir, Select State, Turkey
- Dokuz Eylül University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood Flow Restriction Group
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.
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Elbow bending exercises with blood flow restriction will be performed to the exercise group.
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Experimental: Exercise Group
Elbow bending exercises with resistance exercise band (%70 of 1 maximum repetition) will be performed for one session.
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Elbow bending exercises
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No Intervention: Control Group
10 minutes resting period will be given between evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: baseline measurements and after 10 minutes of one exercise session
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Change of biceps muscle strength(in kg, with hand held dynamometer)
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baseline measurements and after 10 minutes of one exercise session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder proprioception
Time Frame: baseline measurements and after 10 minutes of one exercise session
|
Change of shoulder proprioception for 100 abduction (with bubble inclinometer)
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baseline measurements and after 10 minutes of one exercise session
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Elbow proprioception
Time Frame: baseline measurements and after 10 minutes of one exercise session
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change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer)
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baseline measurements and after 10 minutes of one exercise session
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Modified Pull-Up Test
Time Frame: baseline measurements and after 10 minutes of one exercise session
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Number of pull-ups will be recorded
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baseline measurements and after 10 minutes of one exercise session
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Upper Extremity Closed Kinetic Chain Stabilization Test
Time Frame: baseline measurements and after 10 minutes of one exercise session
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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.
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baseline measurements and after 10 minutes of one exercise session
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Functional Throwing Performance Index
Time Frame: baseline measurements and after 10 minutes of one exercise session
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Participants will throw a ball to shot a frame on a wall.
Number of correct shots will be recorded
|
baseline measurements and after 10 minutes of one exercise session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sevgi Yesilyaprak, Dokuz Eylül University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
November 20, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 20, 2019
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 4, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019/18-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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