NCT06678009

Brief Summary

Evidence regarding the effectiveness of blood flow restriction during isokinetic exercises is insufficient. When the literature is reviewed, it is seen that there are very few studies investigating the effect of isokinetic training program with blood flow restriction on muscle strength and endurance in healthy athletes. In line with this information, the aim of this study was to investigate the effect of an 8-week isokinetic training program combined with blood flow restriction on knee flexor and extensor maximal muscle strength and endurance in runners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

July 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

November 4, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

blood flow restriction (BFR)isokinetic training

Outcome Measures

Primary Outcomes (1)

  • Evaluation of lower extremity muscle strength and muscular endurance using isokinetic dynamometry in runners who met the inclusion criteria for the study.

    Isokinetic knee flexor and extensor muscles strength and endurance were evaluated with the isokinetic dynamometer. All the athletes underwent twice a week for 8 weeks of isokinetic training protocol. Both groups performed the same isokinetic training protocol. Blood flow restriction was applied to the BFR group while the athletes doing isokinetic training protocol, but not to the control group. Isokinetic knee flexor and extensor muscles strength and endurance were re- evaluated at the end of the intervention (48 hours after the last training session).

    Baseline and 8 weeks

Study Arms (2)

The isokinetic training group with blood flow restriction (BFR Group)

ACTIVE COMPARATOR

For the BFR, the occlusion pressure was set to 80% of arterial occlusion pressure as determined. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions.

Device: the isokinetic training group with blood flow restriction

The isokinetic training group without blood flow restriction (Control Group)

OTHER

The isokinetic training group without blood flow restriction. The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions

Device: the isokinetic training group without blood flow restriction

Interventions

The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions.

The isokinetic training group with blood flow restriction (BFR Group)

The isokinetic training protocol for the knee flexor and extensor muscles consisted of 3 sets of 10 repetitions in 60°/sec and 3 sets of 30 repetitions in 180°/sec for 8 weeks, 2 times per week for 16 sessions.

The isokinetic training group without blood flow restriction (Control Group)

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Health Sciences, Gulhane Faculty of Medicine

Ankara, Ankara, 06018, Turkey (Türkiye)

Location

Bihter Akınoğlu

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Yasemin F. Çetinkaya, MD

    Gulhane Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A total of 42 runners were randomly assigned to either the isokinetic training group with blood flow restriction (BFR Group; n= 21) or the isokinetic training group without blood flow restriction (Control Group; n= 21).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Ph.D

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 7, 2024

Study Start

July 15, 2022

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Supporting information (data) will be shared once it is available for publication.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Supporting information will be shared once it is available for publication.
Access Criteria
Supporting information will be uploaded to the journal in which it is submitted for publication.

Locations