Exercise PhysiologyNCT04854356
Blood Flow Restriction During High-intensity Interval Exercise
A study testing Exercise with blood flow restriction (BFR) in people with Exercise Physiology and Biomechanics, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise (HIIE) on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg… Read more about this study
- Who is it for?
- Ages 20 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Physiology, Biomechanics
- What is being tested?
- Exercise with blood flow restriction (BFR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults.
- Age between 20-25.
- Have normal body mass index (BMI).
- Physically active (i.e., exercise regularly for at least three times per week) and total score more than 600MET-min/week based on The International Physical Activity Questionnaire (IPAQ).
- VO2max value above 42 ml/kg/min during cycling test (Above fair VO2max level)(American College of Sports Medicine, 2010).
Who cannot join
- BMI is greater than 25kg/m2.
- Have exercise-related disorders such as coronary heart disease, peripheral vascular diseases, rhabdomyolysis, respiratory inflammation, or have neurological disorders.
- Have implanted electrical devices.
- Have significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Shazlin Shaharudin, +601124222894, shazlin@usm.my
Mohd Bazlan Mukrim, 09-767 2354, bazlan@usm.my
About this study
Official title: The Effects of Blood Flow Restriction During High-intensity Interval Exercise Among Healthy Adult Males: a Randomized Controlled Trial
The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise (HIIE) on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. Participants were randomized to three groups. Intervention was conducted for 12 weeks with 2 sessions per week. During intervention, all groups conducted HIEE on cycle ergometer with or without BFR. Assessments were conducted before the intervention, on the 6th week of intervention and after the intervention. Assessments included physical characteristics, aerobic and anaerobic capacity, lower limb biomechanics during single-leg landing and isokinetic knee strength.
Read the detailed description
The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. The procedure of the study has been approved by Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/20060331) and complied with the Declaration of Helsinki. participants were randomised into one of the following conditions: 1. High-intensity interval exercise without BFR (C Group). 2. High-intensity interval exercise with BFR during exercise phase (E Group). 3 High-intensity interval exercise with BFR during interval phase (I Group). After obtaining the participants' written informed consent form, participants proceeded to pre-intervention tests. Each exercise test needs to be separated by at least 24 hours (First day: VO2max; Second day: Cycling economy; Third day: Isokinetic knee strength and Wingate tests). In the sixth week and after the twelfth week of the exercise intervention, the participants took part in the mid-test and post-test, which was similar protocol in the pre-test. The duration of the intervention is 12 weeks, with two sessions per week. Each exercise session took about an hour and monitored by an exercise physiologist. Exercise intervention comprised of cycle exercises using a cycle ergometer device. First, participants performed a 5-minute warm-up activity (50W). After the warm-up, each group sprinted with 85% VO2max for 3 minutes, where the rotation speed should be maintained at around 60 revolutions per minute (RPM) and then rests for 3 minutes on the ergometer without cycling. Then, they sprinted again after the first break and this sequence of sprint and rest were repeated three times. The 85% of VO2max was determined based on the results from the VO2max test. Exercise (E) Group and Interval (I) Group completed the training with an air cuff placed at the inguinal fold of both legs in sequence in order to provide partial blood flow restriction. The sequence of wrapping was done in random order, but both thighs were wrapped twice in a single intervention session. E Group applied 40% LOP BFR during exercise; I Group I applied 40% LOP BFR during passive rest i.e., interval. On the other hand, C group does not perform BFR during the whole process. Two-factor repeated measures analysis of variance (pre-, mid-and post-intervention time points x three groups) was used to examine the main effects and interaction effects of changes for each tested variables following intervention. If the main effects or interaction effects are significant, the Newman-Keuls post hoc test was applied for multiple comparisons.
- Conditions
- Exercise Physiology, Biomechanics
- Being tested
- Exercise with blood flow restriction (BFR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with blood flow restriction (BFR)Other
All participants completed high-intensity interval exercise plus (1) BFR applied during exercise phase, or (2) BFR applied during interval phase, or (3) no BFR applied.
| Study group | Role | What they receive |
|---|---|---|
| HIE with BFR during exercise phase | Experimental | BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise Receives: Other: Exercise with blood flow restriction (BFR) |
| HIE with BFR during interval phase | Active comparator | BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each during the interval Receives: Other: Exercise with blood flow restriction (BFR) |
| HIE without BFR | No intervention | Cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of aerobic capacity from baseline to post-intervention
Maximum oxygen consumption was measured during Astrand protocol
Measured: 12 weeks
Change of anaerobic capacity from baseline to post-intervention
Maximum power was measured during Wingate test protocol
Measured: 12 weeks
Change of muscular strength from baseline to post-intervention
The strength of the thigh muscle groups was measured using isokinetic device
Measured: 12 weeks
Change of knee joint moments from baseline to post-intervention
Biomechanical data measured during single-leg landing test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazlin Shaharudin, Universiti Sains Malaysia
- Investigators
- Shazlin Shaharudin, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854356
- Sponsor's protocol ID
- USM/JEPeM/20060331
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data in the experiment is anonymous and has been stored in SPSS software. Only researchers can view or extract data. Data were shown as grouped data and participants were not individually identified. The data must be password protected, and only the researcher can access all the data. Before taking the photos and wearing a gas collection mask, the researcher had to ask the participants' permission. The three-dimensional video recorded using Qualisys could not identify the respondent as it only captured the reflective marker number's trajectory on the respondent. Data will be published as scientific articles to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blood Flow Restriction During High-intensity Interval Exercise Among Healthy Adult Males: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04854356
- Acronym / sponsor ID
- USM/JEPeM/20060331
- Conditions
- Exercise Physiology, Biomechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise (HIIE) on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. Participants were randomized to three groups. Intervention was conducted for 12 weeks with 2 sessions per week. During intervention, all groups conducted HIEE on cycle ergometer with or without BFR. Assessments were conducted before the intervention, on the 6th week of intervention and after the intervention. Assessments included physical characteristics, aerobic and anaerobic capacity, lower limb biomechanics during single-leg landing and isokinetic knee strength.
Detailed description
The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. The procedure of the study has been approved by Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/20060331) and complied with the Declaration of Helsinki. participants were randomised into one of the following conditions: 1. High-intensity interval exercise without BFR (C Group). 2. High-intensity interval exercise with BFR during exercise phase (E Group). 3 High-intensity interval exercise with BFR during interval phase (I Group). After obtaining the participants' written informed consent form, participants proceeded to pre-intervention tests. Each exercise test needs to be separated by at least 24 hours (First day: VO2max; Second day: Cycling economy; Third day: Isokinetic knee strength and Wingate tests). In the sixth week and after the twelfth week of the exercise intervention, the participants took part in the mid-test and post-test, which was similar protocol in the pre-test. The duration of the intervention is 12 weeks, with two sessions per week. Each exercise session took about an hour and monitored by an exercise physiologist. Exercise intervention comprised of cycle exercises using a cycle ergometer device. First, participants performed a 5-minute warm-up activity (50W). After the warm-up, each group sprinted with 85% VO2max for 3 minutes, where the rotation speed should be maintained at around 60 revolutions per minute (RPM) and then rests for 3 minutes on the ergometer without cycling. Then, they sprinted again after the first break and this sequence of sprint and rest were repeated three times. The 85% of VO2max was determined based on the results from the VO2max test. Exercise (E) Group and Interval (I) Group completed the training with an air cuff placed at the inguinal fold of both legs in sequence in order to provide partial blood flow restriction. The sequence of wrapping was done in random order, but both thighs were wrapped twice in a single intervention session. E Group applied 40% LOP BFR during exercise; I Group I applied 40% LOP BFR during passive rest i.e., interval. On the other hand, C group does not perform BFR during the whole process. Two-factor repeated measures analysis of variance (pre-, mid-and post-intervention time points x three groups) was used to examine the main effects and interaction effects of changes for each tested variables following intervention. If the main effects or interaction effects are significant, the Newman-Keuls post hoc test was applied for multiple comparisons.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIE with BFR during exercise phase | Experimental | Other: Exercise with blood flow restriction (BFR)BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise |
| HIE with BFR during interval phase | Active comparator | Other: Exercise with blood flow restriction (BFR)BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each during the interval |
| HIE without BFR | No intervention | –Cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male adults.
- Age between 20-25.
- Have normal body mass index (BMI).
- Physically active (i.e., exercise regularly for at least three times per week) and total score more than 600MET-min/week based on The International Physical Activity Questionnaire (IPAQ).
- VO2max value above 42 ml/kg/min during cycling test (Above fair VO2max level)(American College of Sports Medicine, 2010).
Key exclusion criteria (4 listed)
- BMI is greater than 25kg/m2.
- Have exercise-related disorders such as coronary heart disease, peripheral vascular diseases, rhabdomyolysis, respiratory inflammation, or have neurological disorders.
- Have implanted electrical devices.
- Have significant cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with blood flow restriction (BFR)All participants completed high-intensity interval exercise plus (1) BFR applied during exercise phase, or (2) BFR applied during interval phase, or (3) no BFR applied. | Other | HIE with BFR during exercise phase, HIE with BFR during interval phase |
Primary outcome
Change of aerobic capacity from baseline to post-intervention
Time frame: 12 weeks
Maximum oxygen consumption was measured during Astrand protocol
Change of anaerobic capacity from baseline to post-intervention
Time frame: 12 weeks
Maximum power was measured during Wingate test protocol
Change of muscular strength from baseline to post-intervention
Time frame: 12 weeks
The strength of the thigh muscle groups was measured using isokinetic device
Change of knee joint moments from baseline to post-intervention
Time frame: 12 weeks
Biomechanical data measured during single-leg landing test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No. All data in the experiment is anonymous and has been stored in SPSS software. Only researchers can view or extract data. Data were shown as grouped data and participants were not individually identified. The data must be password protected, and only the researcher can access all the data. Before taking the photos and wearing a gas collection mask, the researcher had to ask the participants' permission. The three-dimensional video recorded using Qualisys could not identify the respondent as it only captured the reflective marker number's trajectory on the respondent. Data will be published as scientific articles to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shazlin Shaharudin principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with blood flow restriction (BFR) in people with Exercise Physiology and Biomechanics, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shazlin Shaharudin, PhD (+601124222894, shazlin@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of aerobic capacity from baseline to post-intervention (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.