Effects of blood flow restriction training on muscle strength for elders
| ISRCTN | ISRCTN94656014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94656014 |
- Submission date
- 05/09/2024
- Registration date
- 19/09/2024
- Last edited
- 06/09/2024
- 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 65-85 years old who are without significant injuries within 6 months (such as fractures)
What does the study involve?
Participants are randomly allocated to one of three groups:
1. High blood flow restriction: participants will perform knee extension exercises under high blood flow restriction with low resistance training
2. Low blood flow restriction: participants will perform knee extension exercises under low blood flow restriction with low resistance training
3. Control group: participants will perform knee extension exercises under high resistance training without blood flow restriction.
Sessions are three times a week for 8 weeks and last about 1 hour each, including warm-up, resistance training, resting between sets, and cool-down. Leg muscle strength, muscle mass and functional performance, such as walking and balance, are measured before the intervention, after a 4-week intervention and after an 8-week intervention.
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?
May 2023 to July 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) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effects of an 8-week resistance training with different level of blood flow restriction on muscular strength, dynamic balance for elders |
| Study objectives | Greater blood flow restriction may induce greater improvement on muscular strength and functional performance |
| Ethics approval(s) |
Approved 30/05/2023, China Medical University Hospital Research Ethics Committee (2 Yude Road, Taichung, 40047, Taiwan; +886-4-22052121; irb@mail.cmuh.org.tw), ref: CMUH112-REC3-072 |
| Health condition(s) or problem(s) studied | Healthy elders |
| Intervention | Participants will be randomly allocated into three 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, timed up-and-go test, and skeletal muscle mass measurement before the intervention, after a 4-week intervention and after an 8-week intervention. The interventions for those groups: 1. High blood flow restriction: participants will perform knee extension exercises under high blood flow restriction with low resistance training 2. Low blood flow restriction: participants will perform knee extension exercises under low blood flow restriction with low resistance training 3. Control group: participants will perform knee extension exercises under high resistance training 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 frequency: three times a week for 8 weeks Duration: approximately 1 hour for a session including warm-up, resistance training, resting between sets, and cool-down. |
| Intervention type | Other |
| Primary outcome measure | Muscular strength of the lower extremity measured using a Biodex isokinetic dynamometer before the intervention, after a 4-week intervention and after an 8-week intervention |
| Secondary outcome measures | 1. Dynamic balance measured using the timed up-and-go test before the intervention, after a 4-week intervention and after an 8-week intervention 2. Walking ability measured using the 6-meter walk test before the intervention, after a 4-week intervention and after an 8-week intervention 3. Skeletal muscle mass measured by Inbody 270 before the intervention, after a 4-week intervention and after an 8-week intervention |
| Overall study start date | 30/05/2023 |
| Completion date | 15/07/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Adults aged 65-85 years old 2. Live in Taiwan 3. Without significant injuries in the last 3 months (such as fractures), open wounds on the lower extremity |
| Key exclusion criteria | 1. Musculosekeletal injuries of the lower extremity within 6 months 2. High blood pressure 3. Neural diseases, such as Parkinson's disease |
| Date of first enrolment | 30/05/2023 |
| Date of final enrolment | 29/05/2024 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
No. 100, Section 1
Jingmao Road
Beitun District
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 | https://www.cmu.edu.tw/ |
"ROR" |
https://ror.org/00v408z34 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- CMU
- Location
- Taiwan
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 will be available upon request from Dr Yu-Lin You (oilfish@mail.cmu.edu.tw) until 04/10/2025. The personal information of all participants will be anonymized by code name. |
Editorial Notes
05/09/2024: Study's existence confirmed by the China Medical University Hospital Research Ethics Committee.
