NCT04755608

Brief Summary

It was to compare the effect of low-load resistance training with blood flow restriction (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (DOMS). The study included 13 young women. It is a controlled study designed for individuals to perform two different exercise protocols unilaterally. The persons were randomly allocated into two groups as LI- BFR (Group I, n = 13) and HI-RT (Group II, n = 13). Both groups received training for 6 weeks and 3 days a week. Blood flow restriction was performed only in group I.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

January 30, 2021

Last Update Submit

February 12, 2021

Conditions

Keywords

muscle hypertrophytriceps brachiimuscle strength

Outcome Measures

Primary Outcomes (5)

  • triceps muscle thickness

    Triceps brachial (TB) long head thickness was measured using the Esaote mylab C series ultrasound device.

    6 weeks

  • triceps and biceps strength

    Triceps brachial muscle strength was evaluated with an isokinetic dynamometer (Cybex HUMAC / NORM, CSMI, 2004). Isometric muscle strength measurement was performed at the beginning and end of the study at angular velocities of 0-150 ° elbow range, 60 ° / s (strength measurement)

    6 weeks

  • triceps and biceps endurance

    Triceps brachial muscle strength was evaluated with an isokinetic dynamometer (Cybex HUMAC / NORM, CSMI, 2004). Isometric muscle strength measurement was performed at the beginning and end of the study at angular velocities of 0-150 ° elbow range, 180 ° / s (endurance measurement).

    6 weeks

  • functional performances

    Upper Extremity Y Balance Test

    6 weeks

  • delayed-onset muscle soreness

    Visual Analog Scale

    6 weeks

Study Arms (2)

Low Intensity Blood Flow Restriction Group

EXPERIMENTAL
Other: Low Intensity Exercises with Blood Flow Restriction

High Intensity Resistant Training Group

ACTIVE COMPARATOR
Other: High Intensity Resistant Exercise

Interventions

In the exercise protocol, people exercised resistance between 20% and 30% of 1 MaxRepetition with free weight. In addition, blood flow was restricted in 70% of the arterial occlusion pressure of the individual with the help of a cuff during exercise.

Low Intensity Blood Flow Restriction Group

People included in the study did resistance exercise with free weight at 70-80% of 1 MT.

High Intensity Resistant Training Group

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDue to physiological differences between men and women, it was preferred to include only women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-26,
  • Do not have a chronic disease history and do not use medication,
  • Female individuals were included.

You may not qualify if:

  • People who made resisted exercise in the last 6 months,
  • Smoker,
  • BMI above 30 kg / m2,
  • Individuals with hypertension were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University and Health Sciences Physical Therapy and Rehabilitation

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Study Officials

  • Yunus Emre Tütüneken, MSc

    Istinye University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Self Controlled Randomised Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 16, 2021

Study Start

December 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations