NCT04422301

Brief Summary

Studies on resistance training (RT) associated with blood flow restriction (BFR) is an alternative method of gaining strength and hypertrophy muscle. However, there is a gap correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to investigate this type of training in post-exercise. Objective: investigate and compare autonomic and performance responses of 6 weeks of eccentric RT with different intensities associated or not to BFR in healthy youngsters. Method: This is a randomized clinical trial including 60 healthy men aged 18-35 years, divided into four groups according to exercise intensity and BFR: 80% without BFR, 40% without BFR, 80% with BFR and 40% with BFR. Exercise intensity will be determined by the peak of excentric torque on the isokinetic dynamometry method and by the BFR, as being 40% of the intensity required for the complete examination of the blood flow evaluated by Doppler. Participants will do an eccentric femoral quadriceps muscle exercise session on the isokinetic dynamometer according to the previously randomized group. For recovery analyzes, it will be used: the root-mean-square of the successive normal sinus RR interval difference (rMSSD); high frequency (HF) ms²; HF(nu) and the standard deviation of instantaneous beat-to-beat interval variability (SD1). For performance, it will be used the single leg hop test. For data analysis of the population profile, the descriptive statistical method will be used and the results will be presented with values of means, standard deviations, median and confidence interval. Initially, participants from all study groups will be dichotomized at each performance outcome (muscle strength test on the isokinetic dynamometer and vertical jump test) as "improvement" or "without improvement" in order to demonstrate the behavior of the responses obtained during the training, that is, whether the individual responded to the RT or not. It is worth mentioning that this qualitative analysis will be performed considering the data obtained from the initial, intermediate and final evaluation. The dichotomization of the results of the functional tests will be performed by the typical error of the sample measurement for each test. It will be considered as "improvement" if the participant presents gains in tests above the typical error of the measure. The values obtained from the initial, intermediate and final evaluation will be analyzed independently. Subsequently, the weekly average of the vagal indices (rMSSD, HF and SD1) will be performed in the baseline moment and after 6 weeks of RT moment of each study group. In the sequence, the performance parameters will be correlated with the autonomic parameters in the respective groups. Pearson or Spearman correlation test will be used according to the normality of the data. The level of significance will be p \<0.05 for all tests. The statistical program SPSS (Statistical Package for the Social Sciences) will be used for the analyzes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

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

First Submitted

Initial submission to the registry

June 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

June 1, 2020

Last Update Submit

August 30, 2021

Conditions

Keywords

resistance trainingvascular occlusionperformanceautonomic nervous systemrecovery of physiological function

Outcome Measures

Primary Outcomes (7)

  • Performance

    Single Leg Hop Test

    Baseline

  • Performance

    Single Leg Hop Test

    up to 3 weeks

  • Performance

    Single Leg Hop Test

    after 6 weeks from baseline.

  • HRV - rMSSD

    rMSSD (square root of the mean squared differences of successive N-N intervals)

    during the 6 weeks of training

  • HRV - SD1

    SD1 - the standard deviation of instantaneous beat-to-beat interval variability

    during the 6 weeks of training

  • HRV - HF (ms²)

    HF (ms²) - (high frequency)

    during the 6 weeks of training

  • HRV -HF (nu)

    HF (nu) - (high frequency)

    during the 6 weeks of training

Study Arms (4)

High intensity eccentric training

EXPERIMENTAL

High intensity eccentric training high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.

Other: Blood flow restriction

High intensity eccentric training with blood flow restriction

EXPERIMENTAL

High intensity eccentric training with blood flow restriction high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction

Other: Blood flow restriction

Low intensity eccentric training

EXPERIMENTAL

A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.

Other: Blood flow restriction

Low intensity eccentric training with blood flow restriction

EXPERIMENTAL

A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure)will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.

Other: Blood flow restriction

Interventions

an alternative method to produce strength and muscle hypertrophy with lower intensities

High intensity eccentric trainingHigh intensity eccentric training with blood flow restrictionLow intensity eccentric trainingLow intensity eccentric training with blood flow restriction

Eligibility Criteria

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

You may qualify if:

  • male sex;
  • healthy;
  • aged between 18 and 35 years

You may not qualify if:

  • smokers
  • alcoholics;
  • use drugs that influenced cardiac autonomic activity;
  • cardiovascular, metabolic or endocrine diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Behavior

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
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 9, 2020

Study Start

May 18, 2021

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations