NCT04206345

Brief Summary

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.

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 Jan 2020

Shorter than P25 for not_applicable

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

November 20, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

November 20, 2019

Last Update Submit

August 4, 2020

Conditions

Healthy Individuals

Keywords

blood flow restrictionacute

Outcome Measures

Primary Outcomes (1)

  • Strength

    Change of biceps muscle strength(in kg, with hand held dynamometer)

    baseline measurements and after 10 minutes of one exercise session

Secondary Outcomes (5)

  • Shoulder proprioception

    baseline measurements and after 10 minutes of one exercise session

  • Elbow proprioception

    baseline measurements and after 10 minutes of one exercise session

  • Modified Pull-Up Test

    baseline measurements and after 10 minutes of one exercise session

  • Upper Extremity Closed Kinetic Chain Stabilization Test

    baseline measurements and after 10 minutes of one exercise session

  • Functional Throwing Performance Index

    baseline measurements and after 10 minutes of one exercise session

Study Arms (3)

Blood Flow Restriction Group

EXPERIMENTAL

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

Exercise Group

EXPERIMENTAL

Elbow bending exercises with resistance exercise band (%70 of 1 maximum repetition) will be performed for one session.

Other: exercise

Control Group

NO INTERVENTION

10 minutes resting period will be given between evaluation.

Interventions

exercise with blood flow restrictionOTHER

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

Blood Flow Restriction Group
exerciseOTHER

Elbow bending exercises

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 Eylül University

Izmir, Select State, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sevgi Yesilyaprak

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
reaserch assistant

Study Record Dates

First Submitted

November 20, 2019

First Posted

December 20, 2019

Study Start

January 1, 2020

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)