Effects of blood flow restriction of the lower extremity on functional performance
| ISRCTN | ISRCTN92716243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92716243 |
- Submission date
- 09/12/2023
- Registration date
- 29/12/2023
- Last edited
- 28/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Recently, the blood flow restriction training method has become popular. The common blood flow restriction training method uses voodoo tape, but the extent of blood flow restriction cannot be quantified using such an approach. Currently, there is a blood flow restriction system, which can measure limb occlusion pressure (LOP). However, the effects of different levels of blood flow restriction combined with resistance training on muscle strength and functional performance remain unclear. Hence the purpose of this study is to investigate the effects of different extents of blood flow restriction on muscle strength and functional movement performance.
Who can participate?
People who live in Taiwan and aged from 20-40 years old who are without significant injuries in the last three months (such as fractures)
What does the study involve?
Knee extension with or without blood flow restriction and muscular strength of the lower extremity, balance ability and functional performance, like hopping.
What are the possible benefits and risks of participating
The possible benefits include gaining muscular strength in the lower extremity and further improvement in functional performance. Risks include possible muscle soreness after the intervention.
Where is the study run from?
China Medical University, Taiwan (R.O.C)
When is the study starting and how long is it expected to run for?
April 2023 to April 2024
Who is funding the study?
China Medical University, Taiwan (R.O.C)
Who is the main contact?
Dr Yu-Lin You, oilfish@mail.cmu.edu.tw
Contact information
Public, Scientific, Principal Investigator
No. 100, Section 1
Jingmao Road
Beitun District
Taichung City
406040
Taiwan
| Phone | +886-4-22053366 ext. 7611 |
|---|---|
| oilfish@mail.cmu.edu.tw |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effects of an 8-week different level of blood flow restriction on muscular strength, balance and power |
| Study objectives | Greater blood flow restriction may induce greater improvement on muscular strength and functional performance |
| Ethics approval(s) |
Approved 12/04/2023, China Medical University & Hospital (2 Yude Road, Taichung, 40047, Taiwan; +886-4-22052121; irb@mail.cmuh.org.tw), ref: CMUH112-REC2-029 |
| Health condition(s) or problem(s) studied | Healthy adults |
| Intervention | Participants will be randomly allocated into 3 groups using sealed envelopes, namely high blood flow restriction, low blood flow restriction, and a control group. All participants will undergo isokinetic muscular strength of the lower extremity measurements, Y-balance test and figure-of-eight hopping test before and after the 8-week intervention. The interventions for those groups: 1. High blood flow restriction: participants will perform knee extension exercise under high blood flow restriction with low resistance training (30% 1repetitive maximum, RM) 2. Low blood flow restriction: participants will perform knee extension exercises under low blood flow restriction with low resistance training (30% 1RM) 3. Control group: participants will perform knee extension exercises under high resistance training (60% 1RM) without blood flow restriction. The level of blood flow restriction is determined by the limb occlusion pressure (LOP). For the high blood flow restriction group, the level of blood flow restriction is set at 60% LOP, while for the low blood flow restriction group, the level of blood flow restriction is set at 30% LOP. |
| Intervention type | Other |
| Primary outcome measure | Muscular strength of the lower extremity measured using a Biodex isokinetic dynamometer before and after the 8-week intervention |
| Secondary outcome measures | Balance measured using the Y-balance test and figure-of-eight hopping test before and after the 8-week intervention |
| Overall study start date | 01/08/2022 |
| Completion date | 11/04/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Adults aged from 20-40 years old 2. Live in Taiwan 3. Without significant injuries in the last three months (such as fractures) 4. Open wounds on the lower extremity 5. Pregnancy 6. Normal resting heart rate and blood pressure |
| Key exclusion criteria | 1. Significant injuries of the lower extremity in the last three months (such as fractures) 2. Open wounds on the lower extremity 3. Pregnant individuals 4. Resting heart rate exceeding 120 beats per minute, systolic blood pressure exceeding 120 mmHg diastolic blood pressure exceeding 100 mmHg |
| Date of first enrolment | 20/04/2023 |
| Date of final enrolment | 10/02/2024 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taichung City
406040
Taiwan
Sponsor information
University/education
Department of Sports Medicine
No. 100, Section 1, Jingmao Road
Beitun District
Taichung City
406040
Taiwan
| Phone | +886 (4) 22052121 |
|---|---|
| 038076@tool.caaumed.org.tw | |
| Website | http://www.cmu.edu.cn/eng/ |
"ROR" |
https://ror.org/00v408z34 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plnned publication in a high-impact-peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yu-Lin You (oilfish@mail.cmu.edu.tw) until 04/10/2024. Consent from participants was required and obtained. The personal information of all participants will be anonymized by code name. |
Editorial Notes
28/12/2023: Trial's existence confirmed by China Medical University & Hospital Research Ethics Committee.
