- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05371119
BFR in Overweight Sedentary Subjects
Effects of a Physical Activity Program With Partial Vascular Occlusion on Body Composition, Biomechanics and Walking Energy in Overweight Sedentary Subjects
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
VD
-
Lausanne, VD, Switzerland, 1015
- ISSUL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- IMC between 25 and 35
- vaccin against Covid-19
Exclusion Criteria:
hypertension diabete
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-02081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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