Eccentric Exercise TrainingNCT04773444
Eccentric Cycling Exercise on Hemodynamic and Hemorheologic Properties
A study testing Eccentric cycling training and Concentric cycling training in people with Eccentric Exercise Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The effects of an eccentric endurance training on central and peripheral hemodynamic adaptations and erythrocyte rheology during maximal exercise remained to be unexplored. The current study examined the contribution of rheological functions and/or hemodynamic adaptation to changes in oxygen consumption (VO2)… 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
- Eccentric Exercise Training
- What is being tested?
- Eccentric cycling training and Concentric cycling training
- 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
- 11 Nov 2019to 16 May 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- in sedentary lifestyle, who were nonsmokers, nonusers of medications/vitamins, and free of any cardiopulmonary/hematological risks
Who cannot join
- regular exercise habits (i.e., exercise frequency once per week, duration >20 min).
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 Eccentric and Concentric Cycling Exercise Regimens on Hemodynamic and Hemorheologic Properties in Sedentary Male
The effects of an eccentric endurance training on central and peripheral hemodynamic adaptations and erythrocyte rheology during maximal exercise remained to be unexplored. The current study examined the contribution of rheological functions and/or hemodynamic adaptation to changes in oxygen consumption (VO2) following the matched-power output eccentric (ECT) or concentric cycling training (CCT).
Method: A total of 39 sedentary males were randomly assigned into either CCT (n=13) or ECT (n=13) for 30 min a day, 5 days a week for 6 weeks at 60% of maximal workload or to a CTL (control group, n = 13). A graded exercise test (GXT) was performed before and after the intervention. Central and microvascular adaptations were evaluated using thoracic impedance and near-infrared spectroscopy (NIRS), respectively. Rheological characteristics was determined by an ektacytometer.
Read the detailed description
Endurance training is a well known strategy for improving fitness capacity. However, some populations are intolerance to complete the usual exercise training program, such as chronic heart or pulmonary disease or the elderly. Therefore, ECT is a candidate training strategy for those individuals.
Erythrocytes deformability is significantly related to the blood perfusion in microcirculation. The impaired erythrocyte-related rheology further lead to reduced aerobic capacity by our research team. Therefore, the lower energy consumed in ECT may avoid the oxidative stress. To now, less studies have demonstrated whether ECT influences peripheral hemodynamics by erythrocyte rheology and the blood flow from the central effect.
The investigators aimed to investigate the effects of CCT and ECT on oxygen consumption response explained by changes in local blood perfusion, blood cell rheology, or central function to attempt developing its application in rehabilitation.
- Conditions
- Eccentric Exercise Training
- Being tested
- Eccentric cycling training, Concentric cycling training
- Keywords
- eccentric cycling, erythrocyte, hemodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric cycling trainingBehavioural
- Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer.
- Each training session: 3 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.
- Intensity: Firstly, set at 45% Wmax, and progressively increased 5% per week
Concentric cycling trainingBehavioural
- Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer.
- Each training session: 3 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.
- Intensity: Firstly, set at 45% Wmax, and progressively increased 5% per week
| Study group | Role | What they receive |
|---|---|---|
| Eccentric cycling training | Experimental | Moderate intensity cycling training in eccentric type Receives: Behavioral: Eccentric cycling training |
| Concentric cycling training | Experimental | Moderate intensity cycling training in concentric type (intensity matched the eccentric training) Receives: Behavioral: Concentric cycling training |
| Control group | No intervention | without receiving any exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central and peripheral hemodynamics
Evaluate cardiac and peripheral hemodynamic response to exercise by using noninvasive continuous cardiac output monitoring system and near-infrared spectroscopy (NIRS).
Measured: 12 weeks
Secondary outcomes (2)
Cardiopulmonary fitness
The graded exercise test (GXT) on a bicycle ergometer was performed. The GXT comprised 2 min of unloaded pedaling followed by a continuous increase in the work rate of 30 watt per 3-minute until exhaustion (i.e., progressive exercise to maximal O2 consumption)
Measured: 12 weeks
Erythrocyte rheological characteristics
Isolated erythrocyte first, then detect the cell geometric shape by using the FACSCalibur.
To assess erythrocyte deformability and aggregation by using laser assisted optical rotational red cell analyzer (LoRRca).
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 posted26 Feb 2021
- Study start11 Nov 2019
- Primary completion16 May 2022 (estimated)
- Study completion16 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eccentric Exercise TrainingStudies 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
- 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
- NCT04773444
- Sponsor's protocol ID
- 201900415A3C
- Status last verified
- May 2021
- First submitted
- 25 Feb 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoppeler H. Moderate Load Eccentric Exercise; A Distinct Novel Training Modality. Front Physiol. 2016 Nov 16;7:483. doi: 10.3389/fphys.2016.00483. eCollection 2016.
PubMed 27899894Haynes A, Linden MD, Chasland LC, Nosaka K, Maiorana A, Dawson EA, Dembo LH, Naylor LH, Green DJ. Acute impact of conventional and eccentric cycling on platelet and vascular function in patients with chronic heart failure. J Appl Physiol (1985). 2017 Jun 1;122(6):1418-1424. doi: 10.1152/japplphysiol.01057.2016. Epub 2017 Mar 16.
PubMed 28302709Lindstedt SL, LaStayo PC, Reich TE. When active muscles lengthen: properties and consequences of eccentric contractions. News Physiol Sci. 2001 Dec;16:256-61. doi: 10.1152/physiologyonline.2001.16.6.256. No abstract available.
PubMed 11719600LaStayo PC, Ewy GA, Pierotti DD, Johns RK, Lindstedt S. The positive effects of negative work: increased muscle strength and decreased fall risk in a frail elderly population. J Gerontol A Biol Sci Med Sci. 2003 May;58(5):M419-24. doi: 10.1093/gerona/58.5.m419.
PubMed 12730250
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric and Concentric Cycling Exercise Regimens on Hemodynamic and Hemorheologic Properties in Sedentary Male
- ClinicalTrials.gov ID
- NCT04773444
- Acronym / sponsor ID
- 201900415A3C
- Conditions
- Eccentric Exercise Training
- Keywords
- eccentric cycling, erythrocyte, hemodynamic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 16 May 2022 (estimated)
- Study completion
- 16 May 2022 (estimated)
- First posted
- 26 Feb 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 effects of an eccentric endurance training on central and peripheral hemodynamic adaptations and erythrocyte rheology during maximal exercise remained to be unexplored. The current study examined the contribution of rheological functions and/or hemodynamic adaptation to changes in oxygen consumption (VO2) following the matched-power output eccentric (ECT) or concentric cycling training (CCT).
Method: A total of 39 sedentary males were randomly assigned into either CCT (n=13) or ECT (n=13) for 30 min a day, 5 days a week for 6 weeks at 60% of maximal workload or to a CTL (control group, n = 13). A graded exercise test (GXT) was performed before and after the intervention. Central and microvascular adaptations were evaluated using thoracic impedance and near-infrared spectroscopy (NIRS), respectively. Rheological characteristics was determined by an ektacytometer.
Detailed description
Endurance training is a well known strategy for improving fitness capacity. However, some populations are intolerance to complete the usual exercise training program, such as chronic heart or pulmonary disease or the elderly. Therefore, ECT is a candidate training strategy for those individuals.
Erythrocytes deformability is significantly related to the blood perfusion in microcirculation. The impaired erythrocyte-related rheology further lead to reduced aerobic capacity by our research team. Therefore, the lower energy consumed in ECT may avoid the oxidative stress. To now, less studies have demonstrated whether ECT influences peripheral hemodynamics by erythrocyte rheology and the blood flow from the central effect.
The investigators aimed to investigate the effects of CCT and ECT on oxygen consumption response explained by changes in local blood perfusion, blood cell rheology, or central function to attempt developing its application in rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eccentric cycling training | Experimental | Behavioral: Eccentric cycling trainingModerate intensity cycling training in eccentric type |
| Concentric cycling training | Experimental | Behavioral: Concentric cycling trainingModerate intensity cycling training in concentric type (intensity matched the eccentric training) |
| Control group | No intervention | –without receiving 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)
- in sedentary lifestyle, who were nonsmokers, nonusers of medications/vitamins, and free of any cardiopulmonary/hematological risks
Key exclusion criteria (1 listed)
- regular exercise habits (i.e., exercise frequency once per week, duration >20 min).
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 |
|---|---|---|
| Eccentric cycling training1. Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer. 2. Each training session: 3 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase. 3. Intensity: Firstly, set at 45% Wmax, and progressively increased 5% per week | Behavioural | Eccentric cycling training |
| Concentric cycling training1. Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer. 2. Each training session: 3 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase. 3. Intensity: Firstly, set at 45% Wmax, and progressively increased 5% per week | Behavioural | Concentric cycling training |
Primary outcome
Central and peripheral hemodynamics
Time frame: 12 weeks
Evaluate cardiac and peripheral hemodynamic response to exercise by using noninvasive continuous cardiac output monitoring system and near-infrared spectroscopy (NIRS).
2 secondary outcomes
Cardiopulmonary fitness
Time frame: 12 weeks
Erythrocyte rheological characteristics
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 27899894Hoppeler H. Moderate Load Eccentric Exercise; A Distinct Novel Training Modality. Front Physiol. 2016 Nov 16;7:483. doi: 10.3389/fphys.2016.00483. eCollection 2016.
- Background: PubMed 28302709Haynes A, Linden MD, Chasland LC, Nosaka K, Maiorana A, Dawson EA, Dembo LH, Naylor LH, Green DJ. Acute impact of conventional and eccentric cycling on platelet and vascular function in patients with chronic heart failure. J Appl Physiol (1985). 2017 Jun 1;122(6):1418-1424. doi: 10.1152/japplphysiol.01057.2016. Epub 2017 Mar 16.
- Background: PubMed 11719600Lindstedt SL, LaStayo PC, Reich TE. When active muscles lengthen: properties and consequences of eccentric contractions. News Physiol Sci. 2001 Dec;16:256-61. doi: 10.1152/physiologyonline.2001.16.6.256. No abstract available.
- Results publication: PubMed 12730250LaStayo PC, Ewy GA, Pierotti DD, Johns RK, Lindstedt S. The positive effects of negative work: increased muscle strength and decreased fall risk in a frail elderly population. J Gerontol A Biol Sci Med Sci. 2003 May;58(5):M419-24. doi: 10.1093/gerona/58.5.m419.
- Individual participant dataSharing planned: No
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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.
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 Eccentric cycling training and Concentric cycling training in people with Eccentric Exercise 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 1 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 10 May 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?
Central and peripheral hemodynamics (time frame: 12 weeks). 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 NCT04773444, which also lists 4 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 10 May 2021.