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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Select State
      • İzmir, Select State, Turkey
        • Dokuz Eylul University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: exercise with blood flow restriction
Elbow bending exercises with blood flow restriction will be performed to the exercise group.
Experimental: Exercise Group
Elbow bending exercises with resistance exercise band (%70 of 1 maximum repetition) will be performed for one session.
Other: exercise
Elbow bending exercises
No Intervention: Control Group
10 minutes resting period will be given between evaluation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: baseline measurements and after 10 minutes of one exercise session
Change of biceps muscle strength(in kg, with hand held dynamometer)
baseline measurements and after 10 minutes of one exercise session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
baseline measurements and after 10 minutes of one exercise session
Elbow proprioception
Time Frame: baseline measurements and after 10 minutes of one exercise session
change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer)
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
Number of pull-ups will be recorded
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
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sevgi Yesilyaprak, Dokuz Eylul 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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