NCT03401567

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2019

Completed
Last Updated

November 21, 2019

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

December 23, 2017

Last Update Submit

November 19, 2019

Conditions

Keywords

blood flow restrictionproprioceptionfunctional performancemuscle strength

Outcome Measures

Primary Outcomes (1)

  • Strength

    Change of biceps and triceps muscles strength(in kg, with hand held dynamometer)

    Baseline and 6 weeks later

Secondary Outcomes (6)

  • Shoulder proprioception

    Baseline and 6 weeks later

  • Elbow proprioception

    Baseline and 6 weeks later

  • Functional motor performance

    Baseline and 6 weeks later

  • Functional motor performance

    Baseline and 6 weeks later

  • Functional motor performance

    Baseline and 6 weeks later

  • +1 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Elbow bending exercises with blood flow restriction will be performed to the exercise group.

Other: Exercise group

Control group

NO INTERVENTION

Control group will continue daily activities and a brochure on strengthening exercises and protection from injuries.

Interventions

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.

Exercise group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Sevgi Sevi YESILYAPRAK, PhD

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All of the participants must have no neck and upper extremity pain, any fracture and surgical history for the upper extremity, cervical and thoracic area.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 17, 2018

Study Start

April 18, 2018

Primary Completion

December 20, 2018

Study Completion

November 19, 2019

Last Updated

November 21, 2019

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations