NCT05662891

Brief Summary

The aim of this study is to investigate the effects of blood flow restriction applied during nordic hamstring exercise on neuromuscular activation and endothelial function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

November 24, 2022

Last Update Submit

December 20, 2022

Conditions

Keywords

blood flow restrictionnordic hamstring exerciseendothelial functionmuscular activation

Outcome Measures

Primary Outcomes (3)

  • Endothelial function

    Endothelial function was evaluated with flow-mediated dilation.

    It was evaluated for the control and experimental extremities before exercise.

  • Surface EMG

    It was evaluated for the biceps femoris and semitendinosus muscles of the control and experimental extremities during Nordic hamstring exercise.

    During exercise

  • Endothelial function

    Endothelial function was evaluated with flow-mediated dilation.

    It was evaluated for the control and experimental extremities 15 minutes after exercise. ( Outcomes were evaluated as acute.)

Study Arms (2)

blood flow restriction + Nordic hamstring exercise

EXPERIMENTAL
Other: Blood Flow Restriction

Nordic hamstring exercise

EXPERIMENTAL
Other: Blood Flow Restriction

Interventions

After randomization, a cuff was placed proximal to one lower extremity. Blood flow was restricted from 60% of the arterial occlusion pressure. The other extremity was determined as the control group. 3x5 nordic hamstring exercises were performed. Surface emg was measured for hamstring muscles during exercise.

Also known as: Nordic Hamstring Exercise
Nordic hamstring exerciseblood flow restriction + Nordic hamstring exercise

Eligibility Criteria

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

You may not qualify if:

  • Having chronic diseases such as coronary heart disease, kidney diseases, diabetes, uncontrollable hypertension
  • Having a history of deep vein thrombosis
  • Having a previous hamstring injury
  • To smoke
  • Having a Body Mass Index over 25
  • Having a history of major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr./ Principal Investigator

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 23, 2022

Study Start

March 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations