NCT05091762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

4.2 years

First QC Date

September 23, 2021

Last Update Submit

October 20, 2021

Conditions

Keywords

resistance training

Outcome Measures

Primary Outcomes (2)

  • Endothelium dependent vasodilation

    Percentage of the change

    8 weeks

  • Blood lipid analysis results

    Content of total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein

    8 weeks

Secondary Outcomes (2)

  • The inflammatory state

    8 weeks

  • Endothelial repair function

    8 weeks

Study Arms (8)

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

Interventions

exerciseBEHAVIORAL

Upper limb resistance training with blood flow obstruction

Exercise groupHyperlipidemia and exercise groupHyperlipidemia and medication and exercise groupRoutine treatment and exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aicui Lin, PhD

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Aicui Lin, PhD

CONTACT

JunXia Zhang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 25, 2021

Study Start

October 12, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 25, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations