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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03401567
Other study ID # 3408-GOA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2018
Est. completion date November 19, 2019

Study information

Verified date December 2017
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 19, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Strength Change of biceps and triceps muscles strength(in kg, with hand held dynamometer) Baseline and 6 weeks later
Secondary Shoulder proprioception Change of shoulder proprioception for three direction: 75 external rotation, 45 internal rotation and 100 abduction (with bubble inclinometer) Baseline and 6 weeks later
Secondary Elbow proprioception Change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer) Baseline and 6 weeks later
Secondary Functional motor performance Determine the performance with Upper Extremity Closed Kinetic Chain Stabilization Test (number of touch) Baseline and 6 weeks later
Secondary Functional motor performance Determine the performance with Functional Throwing Performance Index (number of correct shots) Baseline and 6 weeks later
Secondary Functional motor performance Determine the performance with Single Arm Shot Put Test (distance measurement in cm), Baseline and 6 weeks later
Secondary Functional motor performance Determine the performance with Modified Pull-Up Test (number of pulls) Baseline and 6 weeks later
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