CClinicalTrials.gg
CompletedNCT03401567Updated Nov 21, 2019

Effects of Exercises Combined With Blood Flow Restriction in Healthy Individuals

An interventional study of Exercise group in Healthy Individuals, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Individuals

Keywords

  • blood flow restriction
  • proprioception
  • functional performance
  • muscle strength
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Exercise group

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

    Other: Exercise group

  • No intervention
    Control group

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

Interventions

  • OtherExercise 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.

05

What researchers measure

Primary outcomes

  1. Strength

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

    Time frame: Baseline and 6 weeks later

Secondary outcomes

  1. Shoulder proprioception

    Change of shoulder proprioception for three direction: 75 external rotation, 45 internal rotation and 100 abduction (with bubble inclinometer)

    Time frame: Baseline and 6 weeks later

  2. Elbow proprioception

    Change of elbow proprioception for three degrees: 45, 60 and 75 (with digital inclinometer)

    Time frame: Baseline and 6 weeks later

  3. Functional motor performance

    Determine the performance with Upper Extremity Closed Kinetic Chain Stabilization Test (number of touch)

    Time frame: Baseline and 6 weeks later

  4. Functional motor performance

    Determine the performance with Functional Throwing Performance Index (number of correct shots)

    Time frame: Baseline and 6 weeks later

  5. Functional motor performance

    Determine the performance with Single Arm Shot Put Test (distance measurement in cm),

    Time frame: Baseline and 6 weeks later

  6. Functional motor performance

    Determine the performance with Modified Pull-Up Test (number of pulls)

    Time frame: Baseline and 6 weeks later

06

Study locations

1 site
  • Dokuz Eylul University
    İzmir, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03401567
Lead sponsor
Dokuz Eylul University
Responsible party
Deniz Dere Arasan (Postgraduate Student, Dokuz Eylul University) — Principal investigator
First posted
Jan 17, 2018
Start date
Apr 18, 2018
Primary completion
Dec 20, 2018
Completion
Nov 19, 2019
Last update
Nov 21, 2019

Study contacts

Sevgi Sevi YESILYAPRAK, PhD
study director · Dokuz Eylul University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion