There Are no Conditions Under Study. Healthy VolunteersNCT06905964
Eccentric Cycling Exercise With Assistive Devices on Mitochondrial Metabolism in T Lymphocyte
A study testing Eccentric cycling exercise (ECC) and Eccentric cycling exercise with assistive devices (ECA) in people with There Are no Conditions Under Study. Healthy Volunteers, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Eccentric cycling exercise can be a promising modality fwith lower respiratory demands and higher power output. Assistive devices like neuromuscular electrical stimulation (NMES) and compressive garment (CG) accelerates muscle pumping and relieve the eccentric exercise-induced muscle soreness. 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
- There Are no Conditions Under Study. Healthy Volunteers
- What is being tested?
- Eccentric cycling exercise (ECC) and Eccentric cycling exercise with assistive devices (ECA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Feb 2023to 31 Dec 2024
- 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
- Sedentary lifestyle (exercise<20min/session; <1session/week for a year or longer).
- Nonsmokers, nonusers of medications/vitamins.
- No any cardiopulmonary, neuromuscular, and hematological risks.
Who cannot join
- Have regular exercise habits (i.e., exercise frequency once per week, duration >20 min).
- Have retabolic or musculoskeletal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Eccentric Cycling Exercise Training With Assistive Devices on Phenotypes and Mitochondrial Metabolism in T Lymphocytes in Sedentary Men
Eccentric cycling exercise can be a promising modality fwith lower respiratory demands and higher power output. Assistive devices like neuromuscular electrical stimulation (NMES) and compressive garment (CG) accelerates muscle pumping and relieve the eccentric exercise-induced muscle soreness.
Phenotypes and mitochondrial metabolism are crucial to regulate acquired immnunity of T lymphocytes. The study aimed to investigate the effects of eccentric cycling exercise training combined with NMES and CG on mitochondrial phenotypes and bioenergetics in T lymphocytes in sedentary males. The hypothesis were an acute/intense exercise decreased the mitochondrial respiratory capacities of OXPHOS, ETS and bioenergetics, while eccentric cycling training could elevate the diminished mitochondrial functions.
Methods: Twelve sedentary healthy males were randomly assigned to either eccentric cycling with assistive devices (ECA, n=10) or eccentric cycling only (ECC, n=10). All participants performed ECA or ECC at an intensity of 60% to 120% maximal workload progressively on a costumed bicycle ergometer for 40 min/day, 5 days/week for 5 weeks. ECA performed NMES for 20min/session after cycling, while ECC was seated for resting 20 min. Systemic aerobic fitness, phenotypes of T lymphocytes, mitochondrial OXPHOS, ETS respiratory capacities, and bioenergetics in T lymphocytes were analyzed.
- Being tested
- Eccentric cycling exercise (ECC), Eccentric cycling exercise with assistive devices (ECA)
- Keywords
- Eccentric cycling exercise, Neuromuscular electrical stimulation, Compressive garment, Lymphocyte, Mitochondria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric cycling exercise (ECC)Behavioural
Performed exercise training 5 days a week for 5 weeks on an eccentric ergometer.
Each training session: 5 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.
After each training session, rest in sitting position for 20 min. Exercise intensity: Firstly, set at 80% Wmax, and progressively increased 5% per week to 120 % Wmax in the last week.
Eccentric cycling exercise with assistive devices (ECA)Behavioural
Performed exercise training 5 days a week for 5 weeks on an eccentric ergometer.
Each training session: 5 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.
After each training session, receive NMES in sitting position for 20 min.
Intensity: Firstly, set at 80% Wmax, and progressively increased 5% per week to 120 % Wmax in the last week.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric cycling exercise (ECC) | Experimental | High intensity cycling training from 80% to 120% Wmax in eccentric type Receives: Behavioral: Eccentric cycling exercise (ECC) |
| Eccentric cycling exercise with assistive devices (ECA) | Experimental | High intensity cycling training from 80% to 120% Wmax in eccentric type (intensity matched the ECC) Receives: Behavioral: Eccentric cycling exercise with assistive devices (ECA) |
| Control group | No intervention | Perform no exercise training but maintain only regular daily lives only in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial bioenergetics of oxygen consumption rate in T lymphocyte
The bioenergetic health index (BHI) of mitochindria in T lymphocyte was measured. BHI is a parameter for detecting the health status of mitochondrial and efficiency of energy metabolism.
Measured: At baseline and 2 days after completing the 5-week intervention
Systemic aerobic fitness (VO2)
VO2max was determined during the exercise testing. VO2max is the maximum of oxygen deliver and utilization.
Measured: At baseline and 2 days after completing the 5-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start23 Feb 2023
- Primary completion23 Feb 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for There Are no Conditions Under Study. Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905964
- Sponsor's protocol ID
- 202202314A3
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang YC, Cheng ML, Tang HY, Huang CY, Chen KM, Wang JS. Eccentric Cycling Training Improves Erythrocyte Antioxidant and Oxygen Releasing Capacity Associated with Enhanced Anaerobic Glycolysis and Intracellular Acidosis. Antioxidants (Basel). 2021 Feb 13;10(2):285. doi: 10.3390/antiox10020285.
PubMed 33668606Peng SC, Lin YT, Hsu CC, Fu TC, Wang JS. Effects of concentric and eccentric exercise regimens on bioenergetic efficiency of lymphocytes in sedentary males. Eur J Sport Sci. 2024 Dec;24(12):1830-1843. doi: 10.1002/ejsc.12221. Epub 2024 Nov 9.
PubMed 39520384Huang YC, Hsu CC, Fu TC, Wang JS. Interval aerobic/resistance exercise training depresses adrenergic-induced apoptosis of lymphocytes in sedentary males. Eur J Appl Physiol. 2024 Mar;124(3):837-848. doi: 10.1007/s00421-023-05311-3. Epub 2023 Sep 15.
PubMed 37712975
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Cycling Exercise Training With Assistive Devices on Phenotypes and Mitochondrial Metabolism in T Lymphocytes in Sedentary Men
- ClinicalTrials.gov ID
- NCT06905964
- Acronym / sponsor ID
- 202202314A3
- Keywords
- Eccentric cycling exercise, Neuromuscular electrical stimulation, Compressive garment, Lymphocyte, Mitochondria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Apr 2025 (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.
Eccentric cycling exercise can be a promising modality fwith lower respiratory demands and higher power output. Assistive devices like neuromuscular electrical stimulation (NMES) and compressive garment (CG) accelerates muscle pumping and relieve the eccentric exercise-induced muscle soreness.
Phenotypes and mitochondrial metabolism are crucial to regulate acquired immnunity of T lymphocytes. The study aimed to investigate the effects of eccentric cycling exercise training combined with NMES and CG on mitochondrial phenotypes and bioenergetics in T lymphocytes in sedentary males. The hypothesis were an acute/intense exercise decreased the mitochondrial respiratory capacities of OXPHOS, ETS and bioenergetics, while eccentric cycling training could elevate the diminished mitochondrial functions.
Methods: Twelve sedentary healthy males were randomly assigned to either eccentric cycling with assistive devices (ECA, n=10) or eccentric cycling only (ECC, n=10). All participants performed ECA or ECC at an intensity of 60% to 120% maximal workload progressively on a costumed bicycle ergometer for 40 min/day, 5 days/week for 5 weeks. ECA performed NMES for 20min/session after cycling, while ECC was seated for resting 20 min. Systemic aerobic fitness, phenotypes of T lymphocytes, mitochondrial OXPHOS, ETS respiratory capacities, and bioenergetics in T lymphocytes were analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eccentric cycling exercise (ECC) | Experimental | Behavioral: Eccentric cycling exercise (ECC)High intensity cycling training from 80% to 120% Wmax in eccentric type |
| Eccentric cycling exercise with assistive devices (ECA) | Experimental | Behavioral: Eccentric cycling exercise with assistive devices (ECA)High intensity cycling training from 80% to 120% Wmax in eccentric type (intensity matched the ECC) |
| Control group | No intervention | –Perform no exercise training but maintain only regular daily lives only in the study. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sedentary lifestyle (exercise<20min/session; <1session/week for a year or longer).
- Nonsmokers, nonusers of medications/vitamins.
- No any cardiopulmonary, neuromuscular, and hematological risks.
Key exclusion criteria (2 listed)
- Have regular exercise habits (i.e., exercise frequency once per week, duration >20 min).
- Have retabolic or musculoskeletal disease.
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 exercise (ECC)Performed exercise training 5 days a week for 5 weeks on an eccentric ergometer. Each training session: 5 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase. After each training session, rest in sitting position for 20 min. Exercise intensity: Firstly, set at 80% Wmax, and progressively increased 5% per week to 120 % Wmax in the last week. | Behavioural | Eccentric cycling exercise (ECC) |
| Eccentric cycling exercise with assistive devices (ECA)Performed exercise training 5 days a week for 5 weeks on an eccentric ergometer. Each training session: 5 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase. After each training session, receive NMES in sitting position for 20 min. Intensity: Firstly, set at 80% Wmax, and progressively increased 5% per week to 120 % Wmax in the last week. | Behavioural | Eccentric cycling exercise with assistive devices (ECA) |
Primary outcome
Mitochondrial bioenergetics of oxygen consumption rate in T lymphocyte
Time frame: At baseline and 2 days after completing the 5-week intervention
The bioenergetic health index (BHI) of mitochindria in T lymphocyte was measured. BHI is a parameter for detecting the health status of mitochondrial and efficiency of energy metabolism.
Systemic aerobic fitness (VO2)
Time frame: At baseline and 2 days after completing the 5-week intervention
VO2max was determined during the exercise testing. VO2max is the maximum of oxygen deliver and utilization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Results publication: PubMed 33668606Huang YC, Cheng ML, Tang HY, Huang CY, Chen KM, Wang JS. Eccentric Cycling Training Improves Erythrocyte Antioxidant and Oxygen Releasing Capacity Associated with Enhanced Anaerobic Glycolysis and Intracellular Acidosis. Antioxidants (Basel). 2021 Feb 13;10(2):285. doi: 10.3390/antiox10020285.
- Results publication: PubMed 39520384Peng SC, Lin YT, Hsu CC, Fu TC, Wang JS. Effects of concentric and eccentric exercise regimens on bioenergetic efficiency of lymphocytes in sedentary males. Eur J Sport Sci. 2024 Dec;24(12):1830-1843. doi: 10.1002/ejsc.12221. Epub 2024 Nov 9.
- Results publication: PubMed 37712975Huang YC, Hsu CC, Fu TC, Wang JS. Interval aerobic/resistance exercise training depresses adrenergic-induced apoptosis of lymphocytes in sedentary males. Eur J Appl Physiol. 2024 Mar;124(3):837-848. doi: 10.1007/s00421-023-05311-3. Epub 2023 Sep 15.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 exercise (ECC) and Eccentric cycling exercise with assistive devices (ECA) in people with There Are no Conditions Under Study. Healthy Volunteers, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial bioenergetics of oxygen consumption rate in T lymphocyte (time frame: At baseline and 2 days after completing the 5-week intervention). The study lists 2 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 NCT06905964, which also lists 3 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 2 Apr 2025.