Effect of Physiological Ischemic Training on Patients With Atherosclerosis

October 20, 2021 updated by: linaicui, Nanjing First Hospital, Nanjing Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. LDL > 3.11mmol/l and less than 5.63mmol/l;
  2. No serious heart, blood vessel and other related diseases;
  3. There were no skeletal and muscular diseases affecting sports training;
  4. No regular exercise in the past half year (no more than 2 times a week, no more than 30 minutes each time);
  5. Smoking less than 1 pack / year, no history of drinking.

Exclusion Criteria:

  1. Haven't other serious heart and vascular diseases other than hyperlipidemia and / or bones and muscles that affect sports training Diseases;
  2. Pregnant women and people with disabilities;
  3. Other circumstances determined by the researcher not suitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise group
Behavioral: exercise
Upper limb resistance training with blood flow obstruction
NO_INTERVENTION: Blank control group
NO_INTERVENTION: Hyperlipidemia group
NO_INTERVENTION: Hyperlipidemia and medication group
EXPERIMENTAL: Hyperlipidemia and exercise group
Behavioral: exercise
Upper limb resistance training with blood flow obstruction
EXPERIMENTAL: Hyperlipidemia and medication and exercise group
Behavioral: exercise
Upper limb resistance training with blood flow obstruction
NO_INTERVENTION: Routine treatment group
EXPERIMENTAL: Routine treatment and exercise group
Behavioral: exercise
Upper limb resistance training with blood flow obstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelium dependent vasodilation
Time Frame: 8 weeks
Percentage of the change
8 weeks
Blood lipid analysis results
Time Frame: 8 weeks
Content of total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The inflammatory state
Time Frame: 8 weeks
Content of NO, eNOS, iNOS, IFN-γ, IL-6, IL-10 in blood
8 weeks
Endothelial repair function
Time Frame: 8 weeks
eNOSmRNA, iNOSmRNA, EPCs in blood
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Aicui Lin, PhD, Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 12, 2021

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (ACTUAL)

October 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20210604-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

Clinical Trials on exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe