Effect of blood-flow restriction on platelet-rich plasma composition
| ISRCTN | ISRCTN42221463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42221463 |
| Secondary identifying numbers | 001-2024 version |
- Submission date
- 15/04/2024
- Registration date
- 24/04/2024
- Last edited
- 13/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Blood-flow restriction therapy is an exercise in which tourniquets are used on the upper and/or lower limbs to partially restrict the muscle’s blood flow. This stimulates a stress environment in the muscle that, combined with low-load exercise, has been linked with similar strength and hypertrophy (muscle growth) gains to traditional weight training. The tourniquets restrict 80% of the blood flow for about 5 minutes, using around 30% of the load regularly used for the exercise.
The molecules IL-6 and IGF-1 are typically released during exercise and are related to the muscle changes resulting from exercise/training (increased strength, endurance, and volume). Scientific studies have demonstrated that different types of exercise (aerobic, weights, etc) result in different changes in these molecules. The aim of this study is to determine how blood-flow restriction therapy could change the levels of IL-6 and IGF-1 in plasma (the fluid part of the blood). The changes of these molecules in the plasma caused by the blood-flow restriction therapy could be translated in the future to treat some diseases or injuries with substances produced by our bodies.
Who can participate?
Healthy athletic men between 18 and 40 years old with no musculoskeletal conditions that would interfere with exercise
What does the study involve?
1. Personal data collection
2. A short questionnaire to determine eligibility
3. A blood collection before exercise
4. Performing load-low bilateral knee extensions with or without blood-flow restriction therapy. The decision to do it under blood-flow restriction will be randomly allocated on the day of the study
5. Blood collection 10, 20 and 30 minutes after exercise
6. Analysis of the blood samples
Participation in the study will take only 2 hours. The investigators will cover the participation costs and laboratory analysis. All participants will be monitored for 72 hours after to record adverse events and health care coverage. All study data will be protected and only accessible to the investigators for 5 years before destruction.
What are the possible benefits and risks of participating?
Patients will benefit from the study by learning and experiencing an exciting exercise modality that can impact their current sporting activities and training and updated blood tests for health screening purposes.
Blood-flow restriction therapy has been deemed safe under medical supervision. The risks are comparable to those of traditional exercise. However, there are few reports of adverse events such as pain or discomfort during exercise, delayed onset muscle soreness, increased heartbeat, increased blood pressure, numbness, bruising, fainting, clot formation, and muscle injury. These risks are negligible following the current standards.
Where is the study run from?
Centro Profesional Las Mercedes, Clínica Santa Sofía, and Laboratorio Avilab in Caracas (Venezuela)
When is the study starting and how long is it expected to run for?
January 2024 to January 2025
Who is funding the study?
The International Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine (ISAKOS) (USA)
Who is the main contact?
1. Dr Theodorakys Marín, theodorakys.marin@ucv.ve
2. Dra Janet Fermín
Contact information
Public, Scientific, Principal Investigator
Centro Médico Profesional Las Mercedes. Av. Ppal de Las Mercedes, piso 3, consultorio 37.
Caracas
1060
Venezuela
 ORCID ID |
0000-0002-1698-9517 |
|---|---|
| Phone | +58 (0)4143727046 |
| theodorakys.marin@ucv.ve |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | GP practice, Hospital, Laboratory |
| Study type | Other |
| Participant information sheet | 45323_PIS.pdf |
| Scientific title | Blood flow restriction enhanced platelet-rich plasma: a pilot |
| Study acronym | BFR-PRP |
| Study hypothesis | The present study aims to assess platelet-rich plasma (PRP) changes in platelet and leukocyte count, IGF-1, and IL-6 concentration after bilateral low-load knee extensions under blood flow restriction (BFR). The hypothesis is that bilateral low-load knee extensions under BFR will increase platelet and leukocyte count, IGF-1, and IL-6 in PRP prepared after the exercise bout. |
| Ethics approval(s) |
Approved 09/02/2024, Comité de Bioética del Grupo Médico Vargas - Clínica Santa Sofía (Av. Ppal. Santa Sofía, Edif. Clínica Santa Sofía, Caracas, 1061, Venezuela; +58 (0)2123355030; sociedadmedicasantasofia@gmail.com), ref: S/N |
| Condition | Platelet-rich plasma changes after bilateral low-load knee extensions under blood-flow restriction in the athletic population |
| Intervention | Before the intervention, participants will have a pre-exercise peripheral vein catheterization, blood sample draw, and PRP preparation for baseline measurements. Each participant will undergo standard venipuncture in the antecubital fossa by a single phlebotomist under sterile conditions for a total blood draw of 15 ml in a BD vacutainer and undergo a single centrifugation at 1500 rpm for 5 minutes. The plasma portion and buffy coat will be separated from the red blood cells, and samples will be sent to the laboratory and divided into two aliquots, one for cell counts (automated cell counter), the other for IGF-1 and IL-6 immunoassays analysis within 6 hours. The participant will then perform the low-load BFR protocol. The low-load bilateral knee extensions under BFR (using tourniquets at the proximal end of both thighs) will follow the standard protocol of four sets consisting of 30-15-15-15 repetitions, with 30-second rest intervals at 80% of limb occlusive pressure (calculated using arteria pedis ultrasound) and 30% of 1-RM load (using Holten diagram). Individuals will be randomly assigned to the intervention or control groups (performing the low-load knee extension protocol without BFR) at recruitment (1:1). A staff physician will monitor the entire exercise protocol and recovery period for safety and adverse events. Once the exercise protocol is completed, participants will be allowed a recovery period (including rest, walking if desired, and fluid intake) before undergoing the consecutive blood draw. The maximum recovery permitted time will be 5 minutes. The subsequent blood draws and PRP processing will be performed identically to the first at 10, 20, and 30 minutes post-intervention. |
| Intervention type | Other |
| Primary outcome measure | IGF-1 and IL-6 plasmatic concentrations measured by immunoassay analysis at baseline, 10, 20 and 30 minutes after bilateral knee extensions under blood-flow restriction therapy |
| Secondary outcome measures | Platelet and leukocyte plasmatic concentrations measured with an automated cell counter at baseline, 10, 20 and 30 minutes after bilateral knee extensions under blood-flow restriction therapy |
| Overall study start date | 01/01/2024 |
| Overall study end date | 01/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Male |
| Target number of participants | 22 |
| Participant inclusion criteria | 1. Healthy individuals undergoing routine health screening 2. Aged between 18 and 40 years 3. No musculoskeletal conditions that would interfere with exercise |
| Participant exclusion criteria | 1. Systemic inflammatory diseases 2. Cardiovascular risk factors 3. Any blood dyscrasia 4. Tegner Activity scale score <5 5. Under nonsteroidal anti-inflammatory drugs and aspirin treatment within 1 week before testing 6. Previously performed exercises on the testing day |
| Recruitment start date | 12/05/2024 |
| Recruitment end date | 12/08/2024 |
Locations
Countries of recruitment
- Venezuela
Study participating centres
Caracas
1060
Venezuela
Caracas
1061
Venezuela
Caracas
1060
Venezuela
Sponsor information
Other
San Ramon (GeoNames ID 5392593)
San Ramon
94583
United States of America
| Phone | +1 (0)9258071197 |
|---|---|
| isakos@isakos.com | |
| Website | https://www.isakos.com/ |
"ROR" |
https://ror.org/02427qx15 |
Funders
Funder type
Other
Government organisation / Associations and societies (private and public)
- Alternative name(s)
- International Society of Arthroscopy, Knee Surgery & Orthopaedic Sports Medicine, Intl Society of Arthroscopy Knee Surgery and Orthopaedic Sports Med, INT'L SOC OF ARTHROSCOPY KNEE SURG, ISAKOS Society, ISAKOS
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| 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 the Journal of ISAKOS and the 2025 ISAKOS Congress |
| IPD sharing plan | The datasets generated and analyzed during the current study will be published as a supplement to the publication of the results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/04/2024 | No | Yes | ||
| Participant information sheet | in Spanish | 24/04/2024 | No | Yes | |
| Other files | Informed consent form (in Spanish) | 26/04/2024 | No | No | |
| Protocol file | 26/04/2024 | No | No | ||
| Statistical Analysis Plan | 13/08/2024 | No | No |
Additional files
- 45323_PIS.pdf
- 45323_PIS_Spanish.pdf
- in Spanish
- ISRCTN42221463 Protocol.pdf
- ISRCTN42221463 Informed consent form (in Spanish).pdf
- Informed consent form (in Spanish)
- SAP. ISRCTN42221463.pdf
Editorial Notes
13/08/2024: The statistical analysis plan was uploaded as an additional file.
26/04/2024: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The consent form was uploaded as an additional file.
15/04/2024: Study's existence confirmed by the Comité de Bioética del Grupo Médico Vargas - Clínica Santa Sofía.
