ExerciseNCT04823429
HIIT and MICT on Nitric Oxide-mediated Erythrocyte Rheology
A study testing High intensity-interval training (HIIT) and Moderate intensity-continuous (MICT) in people with Exercise and Interval Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Erythrocyte rheological properties affect blood viscoelasticity and consequently regulate vascular resistance to flow shear force, whereas rheological impairments of erythrocytes may result in circulatory disorders. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Interval Training
- What is being tested?
- High intensity-interval training (HIIT) and Moderate intensity-continuous (MICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2021to 4 Sep 2021
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration < 20 min).
Who cannot join
- Exposed to high altitudes (> 3000 m) for at least 1 year.
- Smoker
- Taking medications or vitamins
- Having any cardiopulmonary/hematological risk.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Jong-Shyan Wong, PhD
About this study
Official title: Effects of High Intensity Interval Training and Moderate Intensity Continuous Training on Nitric Oxide-mediated Erythrocyte Rheology
Erythrocyte rheological properties affect blood viscoelasticity and consequently regulate vascular resistance to flow shear force, whereas rheological impairments of erythrocytes may result in circulatory disorders. The aim of this study was to establish an effective exercise strategy for improving individual aerobic capacity and for simultaneously ameliorating the risk of hemorheological dysfunction evoked by a graded exercise test (GXT) and the hypotheses is exercise intervention will improved hemorheological functions by enhancing deformability of erythrocytes via NO-mediated mechanism. This study included 60 healthy sedentary mens (age 20~30) from Chang Gung university than were randomized into the HIIT [3-min intervals at 40% and 80% V̇O2 reserve (V̇O2R),n=10] and MICT(sustained 60% V̇O2R,n=10)on a bicycle ergometer for 30min·d-1, 5 d·wk-1 for 6 wk.
Read the detailed description
Recently, the role of erythrocyte has been more emphasized, which also related with endothelial cell. For coronary artery patients, the endothelial nitric oxide synthase activity in red blood cell (RBC-eNOS activity) is lower than age-matched health people, and it is related with dysfunction of endothelial cell. In cardiovascular diseases. the erythrocyte arginase-1 is active and seize L-arginine with eNOS. When the Arg-1 stimulated by reactive oxygen species (ROS), the nitric oxide (NO) bioactivity decrease and produce more ROS, meanwhile, ROS can go around to stimulate Arg-1. When the RBC-NO production is lowering, it will increase the adhesion activity to endothelial cell due to erythrocyte can be quite close to blood vessel well then release Nitric Oxide, induce the dysfunction and oxidative pressure of endothelial cell. The NO can also regulate the deformability of erythrocytes, and extremely affect oxygen supply to tissue once the deformability and aggregation of erythrocyte become abnormal. Besides NO, the deformability will be affected if erythrocyte is continuously exposed to the endogenous or exogenous ROS, which also increase adhesion to endothelial cell with the exposure of phosphatidylserine. Exercise can regulate the mechanism of NO release from erythrocyte, affecting the rheology of erythrocyte, and improve the anti-oxidation ability. Therefore, as mentioned above which make erythrocyte, as many aspects, become an important role on atherosclerosis disease treatment.
- Conditions
- Exercise, Interval Training
- Being tested
- High intensity-interval training (HIIT), Moderate intensity-continuous (MICT)
- Keywords
- Erythrocyte, eNOS, High intensity interval training, deformability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity-interval training (HIIT)Behavioural
Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
Without any exercise training
Moderate intensity-continuous (MICT)Behavioural
Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High intensity-interval training (HIIT) | Experimental | Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks. Receives: Behavioral: High intensity-interval training (HIIT) |
| Moderate intensity-continuous (MICT) | Experimental | Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks. Receives: Behavioral: Moderate intensity-continuous (MICT) |
| Control group | No intervention | Without any exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular NO production response to exercise training.
Added different inhibitors or agonists to investigate the effects of exercise training on NO production mediated by eNOS-NO pathway.
Measured: 8 weeks
Intracellular ROS production response to exercise training.
Added different inhibitors or agonists to investigate the effects of exercise training on ROS production mediated by eNOS-NO pathway.
Measured: 8 weeks
The levels of eNOS, p-eNOS and Band-3 response to exercise training.
Detect the following protein levels: eNOS, p-eNOS and Band-3, by the western blots.
Measured: 8 weeks
Secondary outcomes (3)
Determination of erythrocyte biological markers by Flow Cytometry
Using the Flow Cytometry to detect the following markers: CD242, CD239, NADPH oxidase 2 (Nox2) and Arginase 1 (Arg1).
Measured: 8 weeks
Erythrocyte deformability
Isolated erythrocyte first, then assess erythrocyte deformability (elongation index ) by using laser assisted optical rotational red cell analyzer (LoRRca).
Measured: 8 weeks
Cardiopulmonary fitness
To assess cardiopulmonary fitness, cardiopulmonary exercise test (CPET) on a cycle ergometer was performed 4 days before and after the intervention. All subjects underwent exercise with a mask to measured oxygen consumption (VO2) breath by breath using a computer-based system.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start5 Mar 2021
- Primary completion4 Sep 2021 (estimated)
- Study completion4 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Shyan Wang, Chang Gung Memorial Hospital
- Investigators
- Jong-Shyan Wang, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823429
- Sponsor's protocol ID
- 202000448A3
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao TY, Fu LL, Wang JS. Hypoxic exercise training causes erythrocyte senescence and rheological dysfunction by depressed Gardos channel activity. J Appl Physiol (1985). 2011 Aug;111(2):382-91. doi: 10.1152/japplphysiol.00096.2011. Epub 2011 May 5.
PubMed 21551009Agre P, King LS, Yasui M, Guggino WB, Ottersen OP, Fujiyoshi Y, Engel A, Nielsen S. Aquaporin water channels--from atomic structure to clinical medicine. J Physiol. 2002 Jul 1;542(Pt 1):3-16. doi: 10.1113/jphysiol.2002.020818.
PubMed 12096044Wang JS, Fu TC, Lien HY, Wang CH, Hsu CC, Wu WC, Chien YW, Cherng WJ. Effect of aerobic interval training on erythrocyte rheological and hemodynamic functions in heart failure patients with anemia. Int J Cardiol. 2013 Sep 30;168(2):1243-50. doi: 10.1016/j.ijcard.2012.11.053. Epub 2012 Nov 27.
PubMed 23199556Chou SL, Huang YC, Fu TC, Hsu CC, Wang JS. Cycling Exercise Training Alleviates Hypoxia-Impaired Erythrocyte Rheology. Med Sci Sports Exerc. 2016 Jan;48(1):57-65. doi: 10.1249/MSS.0000000000000730.
PubMed 26672920Grau M, Pauly S, Ali J, Walpurgis K, Thevis M, Bloch W, Suhr F. RBC-NOS-dependent S-nitrosylation of cytoskeletal proteins improves RBC deformability. PLoS One. 2013;8(2):e56759. doi: 10.1371/journal.pone.0056759. Epub 2013 Feb 12.
PubMed 23424675Suhr F, Brenig J, Muller R, Behrens H, Bloch W, Grau M. Moderate exercise promotes human RBC-NOS activity, NO production and deformability through Akt kinase pathway. PLoS One. 2012;7(9):e45982. doi: 10.1371/journal.pone.0045982. Epub 2012 Sep 25.
PubMed 23049912
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training and Moderate Intensity Continuous Training on Nitric Oxide-mediated Erythrocyte Rheology
- ClinicalTrials.gov ID
- NCT04823429
- Acronym / sponsor ID
- 202000448A3
- Conditions
- Exercise, Interval Training
- Keywords
- Erythrocyte, eNOS, High intensity interval training, deformability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 4 Sep 2021 (estimated)
- Study completion
- 4 Sep 2021 (estimated)
- First posted
- 30 Mar 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.
Erythrocyte rheological properties affect blood viscoelasticity and consequently regulate vascular resistance to flow shear force, whereas rheological impairments of erythrocytes may result in circulatory disorders. The aim of this study was to establish an effective exercise strategy for improving individual aerobic capacity and for simultaneously ameliorating the risk of hemorheological dysfunction evoked by a graded exercise test (GXT) and the hypotheses is exercise intervention will improved hemorheological functions by enhancing deformability of erythrocytes via NO-mediated mechanism. This study included 60 healthy sedentary mens (age 20~30) from Chang Gung university than were randomized into the HIIT [3-min intervals at 40% and 80% V̇O2 reserve (V̇O2R),n=10] and MICT(sustained 60% V̇O2R,n=10)on a bicycle ergometer for 30min·d-1, 5 d·wk-1 for 6 wk.
Detailed description
Recently, the role of erythrocyte has been more emphasized, which also related with endothelial cell. For coronary artery patients, the endothelial nitric oxide synthase activity in red blood cell (RBC-eNOS activity) is lower than age-matched health people, and it is related with dysfunction of endothelial cell. In cardiovascular diseases. the erythrocyte arginase-1 is active and seize L-arginine with eNOS. When the Arg-1 stimulated by reactive oxygen species (ROS), the nitric oxide (NO) bioactivity decrease and produce more ROS, meanwhile, ROS can go around to stimulate Arg-1. When the RBC-NO production is lowering, it will increase the adhesion activity to endothelial cell due to erythrocyte can be quite close to blood vessel well then release Nitric Oxide, induce the dysfunction and oxidative pressure of endothelial cell. The NO can also regulate the deformability of erythrocytes, and extremely affect oxygen supply to tissue once the deformability and aggregation of erythrocyte become abnormal. Besides NO, the deformability will be affected if erythrocyte is continuously exposed to the endogenous or exogenous ROS, which also increase adhesion to endothelial cell with the exposure of phosphatidylserine. Exercise can regulate the mechanism of NO release from erythrocyte, affecting the rheology of erythrocyte, and improve the anti-oxidation ability. Therefore, as mentioned above which make erythrocyte, as many aspects, become an important role on atherosclerosis disease treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity-interval training (HIIT) | Experimental | Behavioral: High intensity-interval training (HIIT)Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks. |
| Moderate intensity-continuous (MICT) | Experimental | Behavioral: Moderate intensity-continuous (MICT)Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks. |
| Control group | No intervention | –Without any exercise training |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration < 20 min).
Key exclusion criteria (4 listed)
- Exposed to high altitudes (> 3000 m) for at least 1 year.
- Smoker
- Taking medications or vitamins
- Having any cardiopulmonary/hematological risk.
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 |
|---|---|---|
| High intensity-interval training (HIIT)Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks. Without any exercise training | Behavioural | High intensity-interval training (HIIT) |
| Moderate intensity-continuous (MICT)Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks. | Behavioural | Moderate intensity-continuous (MICT) |
Primary outcome
Intracellular NO production response to exercise training.
Time frame: 8 weeks
Added different inhibitors or agonists to investigate the effects of exercise training on NO production mediated by eNOS-NO pathway.
Intracellular ROS production response to exercise training.
Time frame: 8 weeks
Added different inhibitors or agonists to investigate the effects of exercise training on ROS production mediated by eNOS-NO pathway.
The levels of eNOS, p-eNOS and Band-3 response to exercise training.
Time frame: 8 weeks
Detect the following protein levels: eNOS, p-eNOS and Band-3, by the western blots.
3 secondary outcomes
Determination of erythrocyte biological markers by Flow Cytometry
Time frame: 8 weeks
Erythrocyte deformability
Time frame: 8 weeks
Cardiopulmonary fitness
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 21551009Mao TY, Fu LL, Wang JS. Hypoxic exercise training causes erythrocyte senescence and rheological dysfunction by depressed Gardos channel activity. J Appl Physiol (1985). 2011 Aug;111(2):382-91. doi: 10.1152/japplphysiol.00096.2011. Epub 2011 May 5.
- Background: PubMed 12096044Agre P, King LS, Yasui M, Guggino WB, Ottersen OP, Fujiyoshi Y, Engel A, Nielsen S. Aquaporin water channels--from atomic structure to clinical medicine. J Physiol. 2002 Jul 1;542(Pt 1):3-16. doi: 10.1113/jphysiol.2002.020818.
- Background: PubMed 23199556Wang JS, Fu TC, Lien HY, Wang CH, Hsu CC, Wu WC, Chien YW, Cherng WJ. Effect of aerobic interval training on erythrocyte rheological and hemodynamic functions in heart failure patients with anemia. Int J Cardiol. 2013 Sep 30;168(2):1243-50. doi: 10.1016/j.ijcard.2012.11.053. Epub 2012 Nov 27.
- Background: PubMed 26672920Chou SL, Huang YC, Fu TC, Hsu CC, Wang JS. Cycling Exercise Training Alleviates Hypoxia-Impaired Erythrocyte Rheology. Med Sci Sports Exerc. 2016 Jan;48(1):57-65. doi: 10.1249/MSS.0000000000000730.
- Background: PubMed 23424675Grau M, Pauly S, Ali J, Walpurgis K, Thevis M, Bloch W, Suhr F. RBC-NOS-dependent S-nitrosylation of cytoskeletal proteins improves RBC deformability. PLoS One. 2013;8(2):e56759. doi: 10.1371/journal.pone.0056759. Epub 2013 Feb 12.
- Background: PubMed 23049912Suhr F, Brenig J, Muller R, Behrens H, Bloch W, Grau M. Moderate exercise promotes human RBC-NOS activity, NO production and deformability through Akt kinase pathway. PLoS One. 2012;7(9):e45982. doi: 10.1371/journal.pone.0045982. Epub 2012 Sep 25.
- Individual participant dataSharing planned: No
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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.
Jong-Shyan Wang, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity-interval training (HIIT) and Moderate intensity-continuous (MICT) in people with Exercise and Interval Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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 30 Mar 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 Taiwan. 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 Jong-Shyan Wang, PhD (+886-3-2118800 ext. 5748, s5492@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracellular NO production response to exercise training. (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823429, which also lists 6 linked publications.
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 30 Mar 2021.