Effects of walking with blood flow restriction on intraocular pressure and ocular perfusion pressure
| ISRCTN | ISRCTN89170828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89170828 |
- Submission date
- 08/11/2022
- Registration date
- 16/11/2022
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Increased intraocular pressure (IOP) and decreased ocular perfusion pressure (OPP) are the main risk factors for the occurrence and development of glaucoma, a common eye condition in which the optic nerve, which connects the eye to the brain, becomes damaged. This study aimed to compare the effects of low-intensity walking with blood flow restriction and moderate-intensity continuous running on IOP and OPP.
Who can participate?
Healthy adult volunteers
What does the study involve?
Participants will be randomly assigned to perform 3 exercise tests:
1. 40% heart rate reserve (HRR) intensity walking (LOW group)
2. 40% HRR intensity walking with blood flow restriction belt of 60% maximum limb occlusive pressure (LOP) (L-BFR group)
3. 60% HRR intensity running (MCE group).
Blood pressure and IOP will be measured before exercise, immediately after exercise, and 5 and 10 minutes after exercise.
What are the possible benefits and risks of participating?
The study could provide potential exercise benefits for healthy people and has limited risks.
Where is the study run from?
Qingdao Haici Hospital (China)
When is the study starting and how long is it expected to run for?
June 2020 to December 2020
Who is funding the study?
1. Natural Science Foundation of Shandong Province (China)
2. Shandong Provincial Natural Science Foundation (China)
Who is the main contact?
Yinghao Li, zhengzhouliyinghao@163.com (China)
Contact information
Principal Investigator
Zhengzhou Shengda University
Zhengzhou
451191
China
| Phone | +86 18203218267 |
|---|---|
| zhengzhouliyinghao@163.com |
Study information
| Study design | Single-centre cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effects of low-intensity walking with blood flow restriction and moderate-intensity running on intraocular pressure and ocular perfusion pressure among healthy adults |
| Study acronym | WALKING+BFR |
| Study objectives | Low-intensity walking with blood flow restriction was more conducive to improving the ocular perfusion pressure (OPP) level than moderate-intensity continuous running. This may be due to an increase in mean arterial pressure. |
| Ethics approval(s) | Approved 07/06/2020, Qingdao Haici Hospital Ethics Committee (No. 4, Renmin Road, Qingdao, China; +86 0532-83777800; qdhaiciwenhua@163.com), ref: 2022-HYJ-475 |
| Health condition(s) or problem(s) studied | Healthy adults |
| Intervention | First, we measured baseline height, weight, resting heart rate, resting blood pressure, and maximum limb occlusive pressure (LOP), and then performed an incremental load test on the same day. The treadmill speed was set at 40% and 60% of the heart rate reserve (HRR) using the recorded incremental load test data. Then, subjects were randomly assigned to perform three exercises through a randomization lottery: 1) 40% HRR intensity walking (LOW group); 2) 40% HRR intensity walking with a 60% LOP blood flow restriction belt (L-BFR group); and, 3) moderate-intensity continuous running with 60% HRR intensity (MCE group). Exercises were carried out from 13:00-16:00 h after lunch. Stimulating drinks containing caffeine or alcohol were prohibited. There must be 72 h between the exercise tests. HR and Rating of Perceived Exertion (RPE) were recorded every 5 minutes from before exercise to 10 minutes after exercise; blood pressure and intraocular pressure (IOP) were tested before exercise, immediately, and 5 min and 10 min after exercise. All exercises and tests were performed at the Xinzheng Second People's Hospital. This study adopts a double-blind design, and neither the experimenter nor the participants know the purpose of the experiment in advance. Each test required 5 min of warm-up activity. The LOW group performed 30 min of walking exercise on a treadmill with 40% HRR intensity. In the L-BFR group, based on the LOW group, a blood flow restriction cuff with 60% LOP pressure should be worn on the proximal end of the thigh, inflated before the exercise, and deflated immediately after the end of the 30-minute exercise. The MCE group performed 30 min of running exercise on a treadmill with 60% HRR intensity. |
| Intervention type | Behavioural |
| Primary outcome measure | Intraocular pressure and ocular perfusion pressure measured using a non-contact jet tonometer at baseline (T0), immediately after exercise (30 min), and 5 and 10 minutes after exercise |
| Secondary outcome measures | 1. Heart rate measured using polar band at baseline (T0) and every 5 minutes until 40 minutes 2. Blood pressure measured using a non-contact jet tonometer at baseline (T0), immediately after exercise (30 min), and 5 and 10 minutes after exercise |
| Overall study start date | 01/06/2020 |
| Completion date | 01/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Aged ≥ 18 years old 2. BMI <24kg/m2 3. No systematic training experience except for daily physical education 4. No bone, cardiovascular disease or other sports-related discomforts 5. A degree of myopia < 200 degrees |
| Key exclusion criteria | Bone, cardiovascular disease or other sports-related discomforts |
| Date of first enrolment | 01/08/2020 |
| Date of final enrolment | 20/08/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Qingdao
266033
China
Sponsor information
University/education
No238 Songling road
Qingdao
266100
China
| Phone | +86 15203152687 |
|---|---|
| haiyangyuwenbing@163.com | |
| Website | http://eweb.ouc.edu.cn/ |
"ROR" |
https://ror.org/04rdtx186 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Shandong Provincial Natural Science Foundation, Shandong Natural Science Foundation, Natural Science Foundation of Shandong, Shandong Province Natural Science Foundation, 山东省自然科学基金
- Location
- China
Government organisation / Local government
- Alternative name(s)
- Shandong Provincial Natural Science Foundation, Shandong Natural Science Foundation, Natural Science Foundation of Shandong, Shandong Province Natural Science Foundation, 山东省自然科学基金
- Location
- China
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned 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 Yinghao Li, zhengzhouliyinghao@163.com. Anonymized intraocular pressure and ocular perfusion pressure data will be shared. Consent was required and obtained from participants. |
Editorial Notes
14/11/2022: Trial's existence confirmed by the Biomedical Research Ethics Committee of Qingdao Haici Medical Group.
