- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03401567
Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals
November 19, 2019 updated by: Deniz Dere Arasan, Dokuz Eylul University
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.
Study Overview
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 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
-
-
-
İzmir, Turkey
- Dokuz Eylül 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
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise group
Elbow bending exercises with blood flow restriction will be performed to the exercise group.
|
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.
|
|
NO_INTERVENTION: Control group
Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: Baseline and 6 weeks later
|
Change of biceps and triceps muscles strength(in kg, with hand held dynamometer)
|
Baseline and 6 weeks later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder proprioception
Time Frame: Baseline and 6 weeks later
|
Change of shoulder proprioception for three direction: 75 external rotation, 45 internal rotation and 100 abduction (with bubble inclinometer)
|
Baseline and 6 weeks later
|
|
Elbow proprioception
Time Frame: Baseline and 6 weeks later
|
Change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer)
|
Baseline and 6 weeks later
|
|
Functional motor performance
Time Frame: Baseline and 6 weeks later
|
Determine the performance with Upper Extremity Closed Kinetic Chain Stabilization Test (number of touch)
|
Baseline and 6 weeks later
|
|
Functional motor performance
Time Frame: Baseline and 6 weeks later
|
Determine the performance with Functional Throwing Performance Index (number of correct shots)
|
Baseline and 6 weeks later
|
|
Functional motor performance
Time Frame: Baseline and 6 weeks later
|
Determine the performance with Single Arm Shot Put Test (distance measurement in cm),
|
Baseline and 6 weeks later
|
|
Functional motor performance
Time Frame: Baseline and 6 weeks later
|
Determine the performance with Modified Pull-Up Test (number of pulls)
|
Baseline and 6 weeks later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 18, 2018
Primary Completion (ACTUAL)
December 20, 2018
Study Completion (ACTUAL)
November 19, 2019
Study Registration Dates
First Submitted
December 23, 2017
First Submitted That Met QC Criteria
January 16, 2018
First Posted (ACTUAL)
January 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2019
Last Update Submitted That Met QC Criteria
November 19, 2019
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 3408-GOA
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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