NCT06389747

Brief Summary

The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 25, 2024

Last Update Submit

April 28, 2024

Conditions

Keywords

painmuscle strengthmuscle tonus

Outcome Measures

Primary Outcomes (4)

  • Visual analog scale

    it will be used for assessment of pain intensity, It is scored between 0-10, and higher scores indicate that the situation is getting worse.

    2 months

  • myoton

    it will be used for assessment of muscle tonus and biomechanic properties, scores are changin according to different parameters.

    2 months

  • dynamometer

    it will be used for assessment of myscle strength, lower scores indicate that the situation is getting worse.

    2 months

  • dolorimeter

    it will be used for assessment of pain thresold pressure, lower scores indicate that the situation is getting worse.

    2 months

Study Arms (2)

%80 BFR group

ACTIVE COMPARATOR

%80 intensity BFR technique will be applied to this group.

Other: BFR technique

%20 BFR group

ACTIVE COMPARATOR

%20 intensity BFR technique will be applied to this group.

Other: BFR technique

Interventions

For BFR application, Airbands brand, wireless, automatic training cuffs will be used. During application, it will be ensured that the device module faces forward and the cuff will be fixed in the correct position by wrapping the band around the metal ring. There will be a space between the skin and the cuff that can fit two fingers. The cuff will then be paired via Bluetooth with the Airbands app installed on the phone. BFR cuffs will be placed proximal to the biceps brachii muscle and pressure will be applied. The cuff will be inflated to automatically detect limb pressure. BFR application with 80% pressure to one group of participants and 20% pressure to the other group will be applied simultaneously with the exercise.

%20 BFR group%80 BFR group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months)

You may not qualify if:

  • Having a previous musculoskeletal system injury
  • Having a condition that prevents resistance exercise
  • Having cardiovascular disease
  • Using medication for blood pressure control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gamze Aydın

Istanbul, 34940, Turkey (Türkiye)

RECRUITING

Istanbul Okan University

Istanbul, 34944, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Gamze Aydın, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participants and assessors will be blind to different intensity BFR groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 29, 2024

Study Start

April 24, 2024

Primary Completion

May 28, 2024

Study Completion

June 15, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations