Activity, MotorNCT06031675
Mechanism for Exercise to Delay Cardiac Aging
An observational study of Activity, Motor and Health Behavior, run by Xiao-dong Zhuang at 1 site in China.
Trial summary
The goal of this clinicaltrial is to assess and compare isokinetic performance, surface electromyography, laboratory parameters, and cardiorespiratory function both before and after engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Activity, Motor, Health Behavior
- What is being tested?
- Vigorous intermittent lifestyle physical activity
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 1 Sep 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: University students
Who may be able to join
- Healthy Adults
- No exercise habits (more than 3 months)
Who cannot join
- Exercising ≥ 3 times per week;
- the presence of chronic diseases, such as hypertension, hyperglycemic states, etc;
- have conducted an exercise program in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The αKlotho Protein-mediated NLRP3/Caspase-1/GSDMD Pathway Counteracts Myocardial Stunning: a Novel Mechanism for Exercise to Delay Cardiac Aging
The goal of this clinicaltrial is to assess and compare isokinetic performance, surface electromyography, laboratory parameters, and cardiorespiratory function both before and after engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy population.
The main question it aims to answer is:
[1] Does VILPA yield effective outcomes?
Throughout the course of the trial, participants will engage in a simulated regimen of vigorous intermittent lifestyle physical activity for a duration of 8 weeks. The efficacy of the exercise protocol will be quantified and evaluated through the utilization of a wearable device.
- Conditions
- Activity, Motor, Health Behavior
- Being tested
- Vigorous intermittent lifestyle physical activity
- Keywords
- vigorous intermittent lifestyle physical activity, wearable device, isokinetic performance
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigorous intermittent lifestyle physical activityOther
The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | The intervention measures encompass the implementation of simulated vigorous intermittent lifestyle physical activity for all participants. The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks. Receives: Other: Vigorous intermittent lifestyle physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Strength Test
Isokinetic muscle strength testing with the Isomed 2000
Measured: 15 minutes
Surface electromyography
Measured: 30 minutes
Exercise Flat Test
cardiopulmonary function
Measured: 30 minutes
Secondary outcomes (2)
Fasting glucose
Measured: 5 minutes
Blood lipid
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start12 May 2023
- Primary completion10 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activity, MotorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiao-dong Zhuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- Lizhen Liao, PhD, Study director, Department of Health, Guangdong Pharmaceutical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031675
- Sponsor's protocol ID
- K0001
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The αKlotho Protein-mediated NLRP3/Caspase-1/GSDMD Pathway Counteracts Myocardial Stunning: a Novel Mechanism for Exercise to Delay Cardiac Aging
- ClinicalTrials.gov ID
- NCT06031675
- Acronym / sponsor ID
- K0001
- Conditions
- Activity, Motor, Health Behavior
- Keywords
- vigorous intermittent lifestyle physical activity, wearable device, isokinetic performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xiao-dong ZhuangUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 11 Sep 2023 (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 goal of this clinicaltrial is to assess and compare isokinetic performance, surface electromyography, laboratory parameters, and cardiorespiratory function both before and after engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy population.
The main question it aims to answer is:
[1] Does VILPA yield effective outcomes?
Throughout the course of the trial, participants will engage in a simulated regimen of vigorous intermittent lifestyle physical activity for a duration of 8 weeks. The efficacy of the exercise protocol will be quantified and evaluated through the utilization of a wearable device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Other: Vigorous intermittent lifestyle physical activityThe intervention measures encompass the implementation of simulated vigorous intermittent lifestyle physical activity for all participants. The specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University students
Key inclusion criteria (2 listed)
- Healthy Adults
- No exercise habits (more than 3 months)
Key exclusion criteria (3 listed)
- Exercising ≥ 3 times per week;
- the presence of chronic diseases, such as hypertension, hyperglycemic states, etc;
- have conducted an exercise program in the past three months.
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 |
|---|---|---|
| Vigorous intermittent lifestyle physical activityThe specific exercise regimen involves performing rope jumping activities three times a day, with each session aimed at surpassing the exercise threshold (not conducted in a continuous manner), where the heart rate should exceed 160 beats per minute. This routine will be undertaken five times a week, continuously for a span of 8 weeks. | Other | intervention group |
Primary outcome
Isometric Strength Test
Time frame: 15 minutes
Isokinetic muscle strength testing with the Isomed 2000
Surface electromyography
Time frame: 30 minutes
Exercise Flat Test
Time frame: 30 minutes
cardiopulmonary function
2 secondary outcomes
Fasting glucose
Time frame: 5 minutes
Blood lipid
Time frame: 5 minutes
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 11 Sep 2023.
- 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.
Lizhen Liao, PhD study director
Department of Health, Guangdong Pharmaceutical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Activity, Motor and Health Behavior, run by Xiao-dong Zhuang at 1 site in China.
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 2 inclusion and 3 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 11 Sep 2023. 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 China. 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?
Isometric Strength Test (time frame: 15 minutes). 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?
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 11 Sep 2023.