Blood flow restriction exercise therapy for people with obesity
| ISRCTN | ISRCTN11246966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11246966 |
| Secondary identifying numbers | OUC-HM-2023005 |
- Submission date
- 08/05/2025
- Registration date
- 08/05/2025
- Last edited
- 08/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity, especially increased visceral fat (around the organs), is a major health concern worldwide. Exercise is known to improve body composition and metabolic health. Traditional moderate-intensity continuous training (MICT) helps reduce visceral fat in obese youths, but its effectiveness depends on the amount of exercise. Blood flow restriction (BFR) training, which uses a compression device to restrict blood flow, may offer a more time-effective exercise option. This study aimed to explore the effects of low-intensity MICT combined with BFR on targeted and non-targeted metabolomics and proteomics in obese young people.
Who can participate?
Individuals aged 18-25 years with a body fat percentage greater than 30%, no long-term medication, smoking, or excessive drinking habits, and no exercise-related contraindications (e.g., cardiovascular, cerebrovascular, or respiratory diseases)
What does the study involve?
Participants will be randomly assigned to one of three groups: a no-intervention control group, an MICT intervention group, or an MICT combined with BFR intervention group. Fasting blood samples will be collected before and after the intervention to analyze plasma metabolomics and proteomics data. Participants' aerobic capacity, body composition, and abdominal fat areas will also be evaluated. Daily dietary intake and physical activity will be recorded for 3 weeks before the intervention and during the 12-week intervention period.
What are the possible benefits and risks of participating?
Participants may lose weight and receive a personalized exercise prescription. The main risk is delayed muscle soreness after exercise. The researchers will ensure the safety of all participants.
Where is the study run from?
Ocean University of China
When is the study starting and how long is it expected to run for?
June 2023 to September 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Shiming Li, haiyanglishiming@163.com
Contact information
Public, Scientific, Principal Investigator
No.238 Songling Road
Qingdao
266100
China
| Phone | +86 (0)15731114483 |
|---|---|
| haiyanglishiming@163.com |
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Fitness/sport facility, Laboratory, University/medical school/dental school |
| Study type | Treatment |
| Scientific title | Effects of blood flow restriction training on metabolomics and proteomics in patients with obesity |
| Study objectives | The difference between aerobic exercise combined with blood flow restriction and not combined with metabolomics and proteomics. |
| Ethics approval(s) |
Approved 01/06/2023, Ocean University of China (No.238 Songling Road, Qingdao, 266100, China; +86 (0)15231509262; 21211913076@ouc.edu.cn), ref: OUC-HM-2023005 |
| Health condition(s) or problem(s) studied | Exercise and metabolic improvement in obese adolescents |
| Intervention | Participants were randomly assigned to two experimental groups (M and B) and one control group (C) by drawing lots. The intervention period lasted for a total of 12 weeks, with three sessions per week. Researchers monitored the heart rate (HR) and blood oxygen saturation during exercise to ensure the safety of participants. Initially, participants were required to perform a 10-minute warm-up activity at an intensity of 50 W on an aerobic power bike. Following the warm-up, participants in all exercise groups engaged in continuous exercise at 60% of their maximal oxygen uptake (VO2max) intensity, maintaining a speed of 60±5 revolutions per minute (RPM), until they overcame a mechanical work of 200kj. A 10-minute cool-down activity was required after the exercise. B group was required to apply a 60% limb occlusive pressure (LOP) using an inflatable cuff (Ariband, Australia) at the proximal inguinal region of both legs based on the exercise protocol of the M group. During exercise, the participants' subjective perceived exertion (RPE) and heart rate (HR) were recorded every 5 minutes. The C group did not receive any exercise intervention throughout the entire intervention period. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline and after the intervention: 1. Plasma non-targeted metabolomics data is measured using liquid chromatography-mass spectrometry (LC-MS) 2. Plasma proteomics data is measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS) 3. Plasma-targeted metabolomics data is measured using liquid chromatography-mass spectrometry (LC-MS) |
| Secondary outcome measures | Measured 3 weeks before the start of the intervention and during the 12-week intervention period: 1. Daily dietary intake measured using a questionnaire every weekend 2. Physical activity measured using a questionnaire every weekend 3. Aerobic capacity is measured using cardiopulmonary exercise testing (CPET), typically with a cycle ergometer, to determine VO₂ max (maximal oxygen uptake) 4. Body composition is measured using bioelectrical impedance analysis (BIA) 5. Abdominal subcutaneous fat area is measured using computed tomography (CT) scans 6. Visceral fat area is measured using computed tomography (CT) scans |
| Overall study start date | 01/06/2023 |
| Completion date | 13/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 36 |
| Key inclusion criteria | 1. Aged 18-25 years 2. Body fat percentage greater than 30% 3. No long-term medication, smoking, or excessive drinking habits 4. No exercise-related contraindications, such as cardiovascular and cerebrovascular diseases, respiratory system diseases, etc |
| Key exclusion criteria | Suffering from any illness that is not suitable for participating in sports |
| Date of first enrolment | 15/05/2025 |
| Date of final enrolment | 30/05/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Qingdao
266100
China
Sponsor information
University/education
No.238 Songling Road
Qingdao
266100
China
| Phone | +86 (0)18203218267 |
|---|---|
| yuwenbing@ouc.edu.cn | |
| Website | https://www.ouc.edu.cn |
"ROR" |
https://ror.org/04rdtx186 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated and analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
08/05/2025: Study's existence confirmed by Ocean University of China.
