BFR in Overweight Sedentary Subjects

May 6, 2022 updated by: Gregoire Millet, University of Lausanne

Effects of a Physical Activity Program With Partial Vascular Occlusion on Body Composition, Biomechanics and Walking Energy in Overweight Sedentary Subjects

This project should allow the investigators to observe the effects of low load training under partial vascular occlusion (BFR) in comparison with resistance training at low load without partial vascular occlusion in sedentary people overweight on parameters : decrease in fat mass; increase in muscle mass 79; muscle strength; decrease in the energy cost of walking; increase in preferred walking speed; improvement in walking pattern in patients overweight. Training under partial vascular occlusion should facilitate physical activity in overweight people as it can be just as effective as a "classic" type training with heavy loads. Thus, this device could allow people for who wear heavy loads can present an obstacle to physical activity to feel more involved in the physical activity programs offered in medical or sports centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to observe the effects of low load training under vascular occlusion (BFR) compared with low load resistance training without vascular occlusion in overweight sedentary people on parameters such as: decrease in fat mass; lower blood sugar levels as well as lower blood triglycerides and cholesterol levels; increased muscle mass; muscle strength; the reduction of the energy cost of walking; increasing the preferred walking speed; improving the walking pattern in overweight patients.

3.2 Primary and secondary endpoints

The first hypothesis is that the BFR drive will be effective in improving walking economy (thus reducing the energy cost of walking) and increasing the preferred walking speed, by improving walking patterns.

The second hypothesis is that BFR training makes it possible to modify the body composition in a slight way and to promote the gain of muscle strength in overweight individuals who do not practice physical activity beforehand. In addition, blood tests will show a decrease in blood sugar, blood triglyceride levels and cholesterol.

3.3 Study design

This single-center project aims to test the effects of low-load training under partial vascular occlusion (BFR) compared to low-load resistance training without vascular occlusion in overweight sedentary people. The main expected effects are a decrease in fat mass, an increase in muscle mass and strength, a decrease in the energy cost of walking as well as an increase in preferential walking speed. This project is part of a continuity of research in a public health context in order to propose adapted and effective physical activity programs for an overweight population unable to train with heavy loads.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IMC between 25 and 35
  • vaccin against Covid-19

Exclusion Criteria:

hypertension diabete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Flow Restriction
Use of the BFR cuff during the training intervention
Training with light load with blood flow restriction (BFR)
Active Comparator: control
No use of inflated cuff
Training with light load with blood flow restriction (BFR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEXA technology
Time Frame: One week before intervention
Body composition assessment: relative lean and fat mass in all body segments
One week before intervention
DEXA technology
Time Frame: One week following the training intervention
Body composition assessment: relative lean and fat mass in all body segments
One week following the training intervention
Evaluation of muscle strength from an isokinetic device
Time Frame: One week before intervention
eccentric and concentric peak torque of the knee extensor muscles
One week before intervention
Evaluation of muscle strength from an isokinetic device
Time Frame: One week following the training intervention
eccentric and concentric peak torque of the knee extensor muscles
One week following the training intervention
Evaluation of the preferential speed of walking in an ecological situation
Time Frame: One week before interventionn
using of a treadmill with measurement of the ground reaction forces
One week before interventionn
Evaluation of the preferential speed of walking in an ecological situation
Time Frame: One week following the training intervention
using of a treadmill with measurement of the ground reaction forces
One week following the training intervention
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
Time Frame: One week before intervention
calculation of the mechanical work
One week before intervention
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
Time Frame: One week following the training intervention
calculation of the mechanical work
One week following the training intervention
Evaluation of the energy cost of walking
Time Frame: One week before intervention
on a treadmill, by indirect calorimetry with gaz exchanges
One week before intervention
Evaluation of the energy cost of walking
Time Frame: One week following the training intervention
on a treadmill, by indirect calorimetry with gaz exchanges
One week following the training intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-02081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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