NCT05573321

Brief Summary

The aim of the study is to measure and compare acute systemic irisin, myostatin and decorin levels after a single session of blood flow restricted resistance exercise and resistance exercise without blood flow restriction in healthy, trained male participants aged 18-35 years. For this purpose, a total of 22 people will be included in the study. Participants will be randomly allocated to 2 exercise groups as resistance exercise with blood flow restriction (BFR-RE) and resistance exercise without blood flow restriction (HL-RE) and will be subjected to cross-over. In the HL-RE intervention, the exercise will be performed with a loading of 80% of 1 RM, with 4 sets x 7 repetitions, with 60 seconds of rest between sets. In the BFR-RE intervention, the exercise will be done as a set of 30 repetitions with a loading of 30% of 1 RM and an additional 3 sets x 15 repetitions, with 30 seconds rest between sets. Total exercise volumes were tried to be equalized and skeletal muscle hypertrophy was selected in accordance with exercise guidelines. In both groups, bilateral leg extension exercise will be performed using the leg extension machine for resistance exercise. In the blood flow restriction group (BFR-RE), the cuff will be placed in the proximal region of the thigh bilaterally, inflated to a pressure equivalent to 50% of the estimated arterial occlusion pressure (AOP), and leg extension exercise will be performed under this condition. In the BFR-RE group, the blood flow restriction time will be between 5-10 minutes. Exercise sessions will be conducted under supervision. Venous blood samples will be collected from the arm antecubital region of the participants just before the exercise session, immediately after the exercise, and 1 hour after the exercise. Plasma irisin, myostatin and decorin levels will be measured from the samples taken. It is well known that resistance exercise is important in maintaining and increasing muscle mass (hypertrophy). Studies have shown the involvement of certain myokines in skeletal muscle hypertrophy, although few studies have been conducted on the systemic response of myokines to BFR-RE that may play a potential role in hypertrophy. Therefore, the planned study aimed to reveal the similarities or differences in the systemic myokine response between BFR-RE and HL-RE.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

October 4, 2022

Last Update Submit

February 13, 2023

Conditions

Keywords

blood flow restrictionmyokines

Outcome Measures

Primary Outcomes (3)

  • change in irisin concentrations

    It was discovered by Bostrom et al in 2012 as a PGC-1α (peroxisome proliferator-activated receptor coactivator 1-alpha)-dependent myokine. It is proteolytically cleaved from the membrane protein FDNC-5 (fibronectin domain containing protein-5) and secreted from skeletal muscle into the circulation in response to exercise. Irisin is a myokine mainly known for its effect on the conversion of white adipose tissue to brown adipose tissue, thereby increasing thermogenesis and energy metabolism. However, there is new evidence to suggest that the iris may have a role in regulating muscle hypertrophy.

    immediately before the exercise session, immediately after the exercise and 1 hour after the exercise

  • change in myostatin concentrations

    It is a member of the TGF-ĂŸ (transforming growth factor-beta) family and acts as a negative regulator of skeletal muscle growth.

    immediately before the exercise session, immediately after the exercise and 1 hour after the exercise

  • change in decorin concentrations

    It has been identified as another myokine that plays a role in muscle hypertrophy. Decorin is thought to be involved in anabolic activity in skeletal muscle by inhibiting myostatin.

    immediately before the exercise session, immediately after the exercise and 1 hour after the exercise

Study Arms (2)

BFR-RE

EXPERIMENTAL

In the BFR-RE intervention, the exercise will be done as a set of 30 repetitions with a loading of 30% of 1 RM and an additional 3 sets x 15 repetitions, with 30 seconds rest between sets.

Other: BFR-REOther: HL-RE

HL-RE

ACTIVE COMPARATOR

In the HL-RE intervention, the exercise will be performed with a loading of 80% of 1 RM, with 4 sets x 7 repetitions, with 60 seconds of rest between sets.

Other: BFR-REOther: HL-RE

Interventions

BFR-REOTHER

In the BFR-RE intervention, the exercise will be done as a set of 30 repetitions with a loading of 30% of 1 RM and an additional 3 sets x 15 repetitions, with 30 seconds rest between sets. In both groups, bilateral leg extension exercise will be performed by using the leg extension machine for resistance exercise. In the blood flow restriction group (BFR-RE), the cuff will be placed in the proximal region of the thigh bilaterally, inflated to a pressure equivalent to 50% of the estimated arterial occlusion pressure (AOP), and leg extension exercise will be performed under this condition. In the BFR-RE group, the blood flow restriction time will be between 5-10 minutes. Venous blood samples will be collected from the arm antecubital region of the participants just before the exercise session, immediately after the exercise, and 1 hour after the exercise. Plasma irisin, myostatin and decorin levels will be measured from the samples taken.

BFR-REHL-RE
HL-REOTHER

In the HL-RE intervention, the exercise will be performed with a loading of 80% of 1 RM, with 4 sets x 7 repetitions, with 60 seconds of rest between sets. In both groups, bilateral leg extension exercise will be performed by using the leg extension machine for resistance exercise. Venous blood samples will be collected from the arm antecubital region of the participants just before the exercise session, immediately after the exercise, and 1 hour after the exercise. Plasma irisin, myostatin and decorin levels will be measured from the samples taken.

BFR-REHL-RE

Eligibility Criteria

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

You may qualify if:

  • Being between 18-35 years old and male gender
  • To have been doing resistance exercises for at least 1 year and to be accustomed to lower extremity resistance exercises
  • Not doing any resistance exercise with restricted blood flow in the last 1 month
  • Not doing lower extremity resistance exercise for at least 48 hours
  • Answering no to all questions in the Exercise Readiness Questionnaire (EGZ-A+)

You may not qualify if:

  • Presence of musculoskeletal injury or disability that may prevent exercise with restricted blood flow
  • Using non-steroidal anti-inflammatory drugs (NSAIDs) or supplements that may have an anti-inflammatory effect
  • Being at risk for cardiovascular disease
  • Regular use of tobacco products
  • Using ergogenic support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (37)

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MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Metin Ergun

    Ege University Hospital, Sports Medicine Department

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sports Medicine Resident

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 10, 2022

Study Start

February 14, 2023

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share