AtherosclerosisNCT05091762
Effect of Physiological Ischemic Training on Patients With Atherosclerosis
A study testing exercise in people with Atherosclerosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To study whether the resistance training with blood flow obstruction in patients in early atherosclerosis period can produce a beneficial effect on preventing atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2021to 31 Dec 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL > 3.11mmol/l and less than 5.63mmol/l;
- No serious heart, blood vessel and other related diseases;
- There were no skeletal and muscular diseases affecting sports training;
- No regular exercise in the past half year (no more than 2 times a week, no more than 30 minutes each time);
- Smoking less than 1 pack / year, no history of drinking.
Who cannot join
- Haven't other serious heart and vascular diseases other than hyperlipidemia and / or bones and muscles that affect sports training Diseases;
- Pregnant women and people with disabilities;
- Other circumstances determined by the researcher not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Aicui Lin, PhD, +8615305179718, linaicui@126.com
About this study
To study whether the resistance training with blood flow obstruction in patients in early atherosclerosis period can produce a beneficial effect on preventing atherosclerosis.
- Conditions
- Atherosclerosis
- Being tested
- exercise
- Keywords
- resistance training
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Upper limb resistance training with blood flow obstruction
| Study group | Role | What they receive |
|---|---|---|
| Blank control group | No intervention | Not described |
| Exercise group | Experimental | Not described Receives: Behavioral: exercise |
| Hyperlipidemia group | No intervention | Not described |
| Hyperlipidemia and medication group | No intervention | Not described |
| Hyperlipidemia and exercise group | Experimental | Not described Receives: Behavioral: exercise |
| Hyperlipidemia and medication and exercise group | Experimental | Not described Receives: Behavioral: exercise |
| Routine treatment group | No intervention | Not described |
| Routine treatment and exercise group | Experimental | Not described Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium dependent vasodilation
Percentage of the change
Measured: 8 weeks
Blood lipid analysis results
Content of total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein
Measured: 8 weeks
Secondary outcomes (2)
The inflammatory state
Content of NO, eNOS, iNOS, IFN-γ, IL-6, IL-10 in blood
Measured: 8 weeks
Endothelial repair function
eNOSmRNA, iNOSmRNA, EPCs in blood
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 posted25 Oct 2021
- Study start12 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, linaicui, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Aicui Lin, PhD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091762
- Sponsor's protocol ID
- KY20210604-02
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 25 Oct 2021
- 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiological Ischemic Training on Patients With Atherosclerosis
- ClinicalTrials.gov ID
- NCT05091762
- Acronym / sponsor ID
- KY20210604-02
- Conditions
- Atherosclerosis
- Keywords
- resistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Oct 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.
To study whether the resistance training with blood flow obstruction in patients in early atherosclerosis period can produce a beneficial effect on preventing atherosclerosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Blank control group | No intervention | – |
| Exercise group | Experimental | Behavioral: exercise |
| Hyperlipidemia group | No intervention | – |
| Hyperlipidemia and medication group | No intervention | – |
| Hyperlipidemia and exercise group | Experimental | Behavioral: exercise |
| Hyperlipidemia and medication and exercise group | Experimental | Behavioral: exercise |
| Routine treatment group | No intervention | – |
| Routine treatment and exercise group | Experimental | Behavioral: exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- LDL > 3.11mmol/l and less than 5.63mmol/l;
- No serious heart, blood vessel and other related diseases;
- There were no skeletal and muscular diseases affecting sports training;
- No regular exercise in the past half year (no more than 2 times a week, no more than 30 minutes each time);
- Smoking less than 1 pack / year, no history of drinking.
Key exclusion criteria (3 listed)
- Haven't other serious heart and vascular diseases other than hyperlipidemia and / or bones and muscles that affect sports training Diseases;
- Pregnant women and people with disabilities;
- Other circumstances determined by the researcher not suitable for the study.
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 |
|---|---|---|
| exerciseUpper limb resistance training with blood flow obstruction | Behavioural | Exercise group, Hyperlipidemia and exercise group, Hyperlipidemia and medication and exercise group, Routine treatment and exercise group |
Primary outcome
Endothelium dependent vasodilation
Time frame: 8 weeks
Percentage of the change
Blood lipid analysis results
Time frame: 8 weeks
Content of total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein
2 secondary outcomes
The inflammatory state
Time frame: 8 weeks
Endothelial repair function
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 25 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Atherosclerosis
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
RecruitingPhase 2
A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
Atherosclerosis, Coronary Artery Disease
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
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.
Aicui Lin, PhD study chair
Nanjing First Hospital, Nanjing Medical University
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 in people with Atherosclerosis, run by Nanjing First Hospital, Nanjing Medical University 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 5 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: status not confirmed, as of the sponsor's last update on 25 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aicui Lin, PhD (+8615305179718, linaicui@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelium dependent vasodilation (time frame: 8 weeks). 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?
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 25 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.