NCT05958056

Brief Summary

Practical blood flow restriction (PBFR) is a new technique of reducing the venous return using a band with a pressure that is applied using a perceived pressure scale. The studies that investigate the acute effect of using PBFR and regular high intensity exercises on the level of growth hormone (GH) and blood lactate (BL) after lower extremity training in collegiate athletes are scarce.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

July 14, 2023

Last Update Submit

August 15, 2023

Conditions

Keywords

blood flow restrictionGrowth hormoneBlood lactate

Outcome Measures

Primary Outcomes (6)

  • Growth Hormone

    Blood test of the level of growth hormone

    Before intervention.

  • Growth Hormone

    Blood test of the level of growth hormone

    Immediately post intervention.

  • Growth Hormone

    Blood test of the level of growth hormone

    15 minutes after the end of intervention.

  • Blood lactate

    Blood test of the level of Blood lactate

    Before intervention.

  • Blood lactate

    Blood test of the level of Blood lactate

    Immediately post intervention.

  • Blood lactate

    Blood test of the level of Blood lactate

    15 minutes after the end of intervention.

Study Arms (2)

Low load resistance exercises with Practical blood flow restriction (PBFR)

EXPERIMENTAL

Participants in the experimental group performed one session of 30% 1RM with Practical blood flow restriction training. The number of repetitions in every set was 15 times with PBFR.19 Participants in the experimental group used the elite band (occlusion training bands) for both thighs during the training session. The width of the thigh band was 5cm, which would produce a pressure between 160-240 mmHg. This pressure range is appropriate for most of the individuals who used PBFR.27 The perceived pressure scale (PPS) was used to estimate the appropriate pressure (7 out of 10) in training before performing the exercises.28,29 The blood flow restriction bands booklet was used30 along with previous studies to design the training session. Participants removed the BFR band immediately after the end of the training session.

Other: Resistance exercise

High resistance exercises

ACTIVE COMPARATOR

Participants in the control group performed one session of 80% 1RM without PBFR. The number of repetitions in every set was 10 times.

Other: Resistance exercise

Interventions

The training session included leg curl and leg extension exercises with 4 sets each. Participants started with leg extension exercise for 4 sets with a 30-second rest periods between the sets. Then, participants took a rest for 60 seconds. Afterward, participants performed leg curl exercise for 4 sets with a 30-second rest periods between the sets. Exercises in each set were performed continuously (uninterrupted) with a speed of 2 seconds for each repetition and a medium exercise performance speed.

High resistance exercisesLow load resistance exercises with Practical blood flow restriction (PBFR)

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Student collegiate athletes.
  • Age of 18 years and older.
  • Free from any cardiovascular or respiratory disorders and did not have any injuries during the previous 12 months.

You may not qualify if:

  • Students who were taking any medications for chronic conditions.
  • Student who were taking any supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alia Alghwiri, PhD

    The University of Jordan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 24, 2023

Study Start

March 1, 2021

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations