NCT05371119

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

April 19, 2022

Last Update Submit

May 6, 2022

Conditions

Keywords

blood flow restriction

Outcome Measures

Primary Outcomes (10)

  • DEXA technology

    Body composition assessment: relative lean and fat mass in all body segments

    One week before intervention

  • DEXA technology

    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

    eccentric and concentric peak torque of the knee extensor muscles

    One week before intervention

  • Evaluation of muscle strength from an isokinetic device

    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

    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

    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.

    calculation of the mechanical work

    One week before intervention

  • Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.

    calculation of the mechanical work

    One week following the training intervention

  • Evaluation of the energy cost of walking

    on a treadmill, by indirect calorimetry with gaz exchanges

    One week before intervention

  • Evaluation of the energy cost of walking

    on a treadmill, by indirect calorimetry with gaz exchanges

    One week following the training intervention

Study Arms (2)

Blood Flow Restriction

EXPERIMENTAL

Use of the BFR cuff during the training intervention

Other: Exercise Intervention

control

ACTIVE COMPARATOR

No use of inflated cuff

Other: Exercise Intervention

Interventions

Training with light load with blood flow restriction (BFR)

Blood Flow Restrictioncontrol

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • hypertension diabete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISSUL

Lausanne, Canton of Vaud, 1015, Switzerland

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
BFR inflated 20 mmHg
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2022

First Posted

May 12, 2022

Study Start

February 1, 2022

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations