Low-intensity interval exercise with blood flow restriction increased plasma cardiac troponin
| ISRCTN | ISRCTN59736069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59736069 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Ocean University of China |
| Funder | Natural Science Foundation of Shandong Province |
- Submission date
- 14/01/2024
- Registration date
- 24/01/2024
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Blood flow restriction (BFR) training can induce endurance adaptations with low-intensity training, but its cardiac risks remain unclear compared to those without BFR. Consequently, the influence of low-intensity interval exercise with and without BFR and high-intensity interval training (HIIT) on cardiac troponin will be determined in this study.
Who can participate?
Physically active healthy male volunteers aged between 18 and 26 years old
What does the study involve?
The participants will complete three exercise tests in random order, including 40% VO2max low-intensity cycling without BFR (group L), 40% VO2max low-intensity cycling with BFR set at 60% limb occlusion pressure (LOP) (group B), and 80% VO2max high-intensity cycling without BFR (group H). Participant muscle oxygen, blood flow, oxygen uptake (VO2), heart rate (HR), perceived exertion (RPE) rating, and pain levels were determined before and after exercise, after cuff inflation, and pre-and post-each exercise. Moreover, before each protocol, immediately after the exercises, and 3 and 4 hours after each exercise, elbow vein blood samples were collected to evaluate serum lactate (LA) and high-sensitivity cardiac troponin T (cTnT).
What are the possible benefits and risks of participating?
The benefits of participating include obtaining a fitness exercise prescription, while the risk is that muscle soreness may occur after high-intensity exercise.
Where is the study run from?
Ocean University of China (China)
When is the study starting and how long is it expected to run for?
January 2021 to March 2022
Who is funding the study?
The Natural Science Foundation of Shandong Province (No.ZR2022MC205) (China)
Who is the main contact?
Yu Wenbing (haiyangyuwenbing@163.com) and Li Shiming (Shiming Li@ouc.edu.cn).
Contact information
Public, Scientific
238 Songling Road, Laoshan District
Qingdao City, Shandong Province
266101
China
| Phone | +8615731114483 |
|---|---|
| haiyangyuwenbing@163.com |
Principal investigator
238 Songling Road, Laoshan District
Qingdao City, Shandong Province
266101
China
| Phone | +8616651738983 |
|---|---|
| Shiming.li@ouc.edu.cn |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-design trial |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | The effect of low-intensity interval exercise with blood flow restriction on plasma cardiac troponin: a cross-design trial |
| Study objectives | Low-intensity interval exercise combined with blood flow restriction causes high-sensitivity cardiac troponin T (cTnT) elevations compared to those without blood flow restriction. The increase is similar to high-intensity interval exercise (HIIE) protocols. |
| Ethics approval(s) |
Approved 08/11/2021, Ocean University of China (238 Songling Road, Laoshan District, Qingdao City, Shandong Province, 266101, China; None provided; 21211913076@ouc.edu.cn), ref: OUC-HM-2021016 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| Intervention | This study is a cross-sectional study, with participants being healthy adults and college students from the school basketball team in three intervention groups involving three types of exercise: 1. 40% VO2max low-intensity cycling without blood flow restriction (Group L) 2. 40% VO2max low-intensity cycling with blood flow restriction set at 60% limb occlusion pressure (LOP) (Group B) 3. 80% VO2max high-intensity cycling without blood flow restriction (Group H) The crossover experiment in the present study will require the participants to visit the laboratory four times at a minimum of 48-hour intervals. The individuals will be asked to not perform vigorous physical activity 24 hours before each meeting. A hot, neutral environment and approximately similar times will be maintained throughout data collection. The participants familiarise themselves with the assessment protocols during initial laboratory visits. The individuals also will complete a graded physical activity protocol to determine their VO2max. During the subsequent visits, the participants will complete three physical activity protocols in random order. The exercise plans utilised in the current study will be chosen to represent current aerobic exercise guidelines that incorporated or did not incorporate BFR. Participant muscle oxygen, blood flow, oxygen uptake (VO2), HR, perceived exertion (RPE) rating, and pain levels will be determined before and after exercise, after cuff inflation, and pre-and post-each exercise. Moreover, before each protocol, immediately after the exercises, and 3 and 4 hours after each exercise, elbow vein blood samples will be collected to evaluate lactate (LA) and high-sensitivity cardiac troponin T (cTnT). Exercise protocol Before the intermittent cycling protocol, the participants will be asked to rest on the cycle ergometer for 5 min to obtain their baseline (Pre) responses. Subsequently, the cuffs will be inflated to 60% LOP (only group B) during a 1-minute rest. The exercise protocols of groups L and H included a 1 min rest. The individuals will be required to complete 18 sets of 2-minute cycling intervals with a 1-minute rest between sets. The intermittent cycling procedure in the present study will be based on the hypothesis that work-rest Interval with inflated pressure cuffs is advantageous over continuous cycling when considering the incorporation of BFR. For the cycling conditions that included BFR, the blood flow in each leg will be restricted with a 7 cm wide nylon inflatable cuff (The Occlusion Cuff, Belfast, Britain). The cuff will be positioned around the thigh at the most proximal location. The pressure in the cuff will be sustained throughout the workout before being deflated immediately upon completion of the last cycling set. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
High-sensitivity cardiac troponin T in plasma is measured using electrochemiluminescence technology-based high-sensitivity immunoassay at baseline, 0, 3 and 4 hours |
| Key secondary outcome measure(s) |
Oxygen uptake measured using a gas metabolism analyzer over the exercise test |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 26 Years |
| Sex | Male |
| Target sample size at registration | 12 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Male 2. No diseases that are not suitable for high-intensity exercise 3. Individuals reporting performing moderate to high-intensity aerobic exercises for a minimum of 150min/week per the American College of Sports Medicine (ACSM) guidelines. |
| Key exclusion criteria | Having cardiovascular and skeletal muscle diseases |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 15/02/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Qingdao City, Shandong Province
266101
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/09/2024 | 11/06/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/06/2025: Publication reference added.
23/01/2024: Study's existence confirmed by Ocean University of China Ethics Committee.
