Back to resultsEffect of Physiological Ischemic Training on Patients With Atherosclerosis
Primary Purpose
Atherosclerosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis focused on measuring resistance training
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Nanjing First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
No Intervention
Experimental
No Intervention
No Intervention
Experimental
Experimental
No Intervention
Experimental
Arm Label
Blank control group
Exercise group
Hyperlipidemia group
Hyperlipidemia and medication group
Hyperlipidemia and exercise group
Hyperlipidemia and medication and exercise group
Routine treatment group
Routine treatment and exercise group
Arm Description
Outcomes
Primary Outcome Measures
Endothelium dependent vasodilation
Percentage of the change
Blood lipid analysis results
Content of total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein
Secondary Outcome Measures
The inflammatory state
Content of NO, eNOS, iNOS, IFN-γ, IL-6, IL-10 in blood
Endothelial repair function
eNOSmRNA, iNOSmRNA, EPCs in blood
Full Information
NCT ID
NCT05091762
First Posted
September 23, 2021
Last Updated
October 20, 2021
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05091762
Brief Title
Effect of Physiological Ischemic Training on Patients With Atherosclerosis
Official Title
Effect of Physiological Ischemic Training on Patients With Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
resistance training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blank control group
Arm Type
No Intervention
Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Hyperlipidemia group
Arm Type
No Intervention
Arm Title
Hyperlipidemia and medication group
Arm Type
No Intervention
Arm Title
Hyperlipidemia and exercise group
Arm Type
Experimental
Arm Title
Hyperlipidemia and medication and exercise group
Arm Type
Experimental
Arm Title
Routine treatment group
Arm Type
No Intervention
Arm Title
Routine treatment and exercise group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
Upper limb resistance training with blood flow obstruction
Primary Outcome Measure Information:
Title
Endothelium dependent vasodilation
Description
Percentage of the change
Time Frame
8 weeks
Title
Blood lipid analysis results
Description
Content of total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The inflammatory state
Description
Content of NO, eNOS, iNOS, IFN-γ, IL-6, IL-10 in blood
Time Frame
8 weeks
Title
Endothelial repair function
Description
eNOSmRNA, iNOSmRNA, EPCs in blood
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aicui Lin, PhD
Phone
+8615305179718
Email
linaicui@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
JunXia Zhang, PhD
Phone
+8615850770739
Email
15850770739@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aicui Lin, PhD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aicui Lin, PhD
Phone
+8615305179718
Email
linaicui@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Physiological Ischemic Training on Patients With Atherosclerosis
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