OverweightNCT05371119
BFR in Overweight Sedentary Subjects
A study testing Exercise Intervention in people with Overweight, run by University of Lausanne at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- IMC between 25 and 35
- vaccin against Covid-19
Who cannot join
- hypertension diabete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Exercise Intervention
- Keywords
- blood flow restriction
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
Training with light load with blood flow restriction (BFR)
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction | Experimental | Use of the BFR cuff during the training intervention Receives: Other: Exercise Intervention |
| control | Active comparator | No use of inflated cuff Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA technology
Body composition assessment: relative lean and fat mass in all body segments
Measured: One week before intervention
DEXA technology
Body composition assessment: relative lean and fat mass in all body segments
Measured: One week following the training intervention
Evaluation of muscle strength from an isokinetic device
eccentric and concentric peak torque of the knee extensor muscles
Measured: One week before intervention
Evaluation of muscle strength from an isokinetic device
eccentric and concentric peak torque of the knee extensor muscles
Measured: 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
Measured: 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
Measured: One week following the training intervention
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
calculation of the mechanical work
Measured: One week before intervention
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
calculation of the mechanical work
Measured: One week following the training intervention
Evaluation of the energy cost of walking
on a treadmill, by indirect calorimetry with gaz exchanges
Measured: One week before intervention
Evaluation of the energy cost of walking
on a treadmill, by indirect calorimetry with gaz exchanges
Measured: One week following the training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Feb 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregoire Millet, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371119
- Sponsor's protocol ID
- 2021-02081
- Status last verified
- May 2022
- First submitted
- 19 Apr 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Citherlet T, Christe S, Cattin A, Mota GR, Millet GP. Remote coaching with blood flow restriction training: impact on strength, body composition, metabolism, and walking energetics in overweight adults. Eur J Appl Physiol. 2026 Sep 8. doi: 10.1007/s00421-026-06422-3. Online ahead of print.
PubMed 42709150
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Activity Program With Partial Vascular Occlusion on Body Composition, Biomechanics and Walking Energy in Overweight Sedentary Subjects
- ClinicalTrials.gov ID
- NCT05371119
- Acronym / sponsor ID
- 2021-02081
- Conditions
- Overweight
- Keywords
- blood flow restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction | Experimental | Other: Exercise InterventionUse of the BFR cuff during the training intervention |
| control | Active comparator | Other: Exercise InterventionNo use of inflated cuff |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- IMC between 25 and 35
- vaccin against Covid-19
Key exclusion criteria (1 listed)
- hypertension diabete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionTraining with light load with blood flow restriction (BFR) | Other | Blood Flow Restriction, control |
Primary outcome
DEXA technology
Time frame: One week before intervention
Body composition assessment: relative lean and fat mass in all body segments
DEXA technology
Time frame: One week following the training intervention
Body composition assessment: relative lean and fat mass in all body segments
Evaluation of muscle strength from an isokinetic device
Time frame: One week before intervention
eccentric and concentric peak torque of the knee extensor muscles
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
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
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
Analysis of the biomechanics of walking on a treadmill instrumented with power platforms.
Time frame: One week before intervention
calculation of the mechanical work
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
Evaluation of the energy cost of walking
Time frame: One week before intervention
on a treadmill, by indirect calorimetry with gaz exchanges
Evaluation of the energy cost of walking
Time frame: One week following the training intervention
on a treadmill, by indirect calorimetry with gaz exchanges
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 42709150Citherlet T, Christe S, Cattin A, Mota GR, Millet GP. Remote coaching with blood flow restriction training: impact on strength, body composition, metabolism, and walking energetics in overweight adults. Eur J Appl Physiol. 2026 Sep 8. doi: 10.1007/s00421-026-06422-3. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Overweight, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEXA technology (time frame: One week before intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.