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BFR in Overweight Sedentary Subjects

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
University of Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring blood flow restriction

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

hypertension diabete

Sites / Locations

  • ISSUL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Flow Restriction

control

Arm Description

Use of the BFR cuff during the training intervention

No use of inflated cuff

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 19, 2022
Last Updated
May 6, 2022
Sponsor
University of Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT05371119
Brief Title
BFR in Overweight Sedentary Subjects
Official Title
Effects of a Physical Activity Program With Partial Vascular Occlusion on Body Composition, Biomechanics and Walking Energy in Overweight Sedentary Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
blood flow restriction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The procedure will consist of 6 weeks of training with or without partial vascular occlusion (depending on group A or group B) at the rate of 3 sessions per week (for a total of 18 training sessions).
Masking
Participant
Masking Description
BFR inflated 20 mmHg
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction
Arm Type
Experimental
Arm Description
Use of the BFR cuff during the training intervention
Arm Title
control
Arm Type
Active Comparator
Arm Description
No use of inflated cuff
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Training with light load with blood flow restriction (BFR)
Primary Outcome Measure Information:
Title
DEXA technology
Description
Body composition assessment: relative lean and fat mass in all body segments
Time Frame
One week before intervention
Title
DEXA technology
Description
Body composition assessment: relative lean and fat mass in all body segments
Time Frame
One week following the training intervention
Title
Evaluation of muscle strength from an isokinetic device
Description
eccentric and concentric peak torque of the knee extensor muscles
Time Frame
One week before intervention
Title
Evaluation of muscle strength from an isokinetic device
Description
eccentric and concentric peak torque of the knee extensor muscles
Time Frame
One week following the training intervention
Title
Evaluation of the preferential speed of walking in an ecological situation
Description
using of a treadmill with measurement of the ground reaction forces
Time Frame
One week before interventionn
Title
Evaluation of the preferential speed of walking in an ecological situation
Description
using of a treadmill with measurement of the ground reaction forces
Time Frame
One week following the training intervention
Title
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
Description
calculation of the mechanical work
Time Frame
One week before intervention
Title
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
Description
calculation of the mechanical work
Time Frame
One week following the training intervention
Title
Evaluation of the energy cost of walking
Description
on a treadmill, by indirect calorimetry with gaz exchanges
Time Frame
One week before intervention
Title
Evaluation of the energy cost of walking
Description
on a treadmill, by indirect calorimetry with gaz exchanges
Time Frame
One week following the training intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: IMC between 25 and 35 vaccin against Covid-19 Exclusion Criteria: hypertension diabete
Facility Information:
Facility Name
ISSUL
City
Lausanne
State/Province
VD
ZIP/Postal Code
1015
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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BFR in Overweight Sedentary Subjects

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