Impact of Exercise Training on Cardiac Function in Man | NCT01881139

Studies
Impact of Exercise Training on Cardiac Function in Man

NCT01881139

Sponsor

No. 150 Central Hospital of the Chinese People Liberation Army

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

46Actual

Phase

Early Phase 1

Conditions

Cardiovascular Disease

Interventions

exercise training

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jun 12, 2013

First Submission Date that Met QC Criteria

Jun 17, 2013

First Posted Date

Jun 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids.

Detailed Description

Exercise can increase the mass of left ventricle, which is also called athletic heart. Athletic heart is most frequently encountered as a pathological manifestation of cardiovascular disease, and the early determinants of athelitic remodeling in the general population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000 meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to exercise program and 3 months after exercise.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental 1	Experimental	men with exercise training for 3 months	Behavioral: exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise training	Behavioral		experimental 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of cardiac function at baseline to exercise training for 3 months		baseline to 3 months

Secondary Outcomes

Measure	Description	Time Frame
change of lipoprotein at baseline to exercise training for 3 months		baseline to 3 months
change of heart rate at baseline to exercise training for 3 months		baseline to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men
age 18-25 years
body mass index (BMI) 18-25 kg/m2
no regular exercise
no tobacco use
no current use of prescribed medications
no self-report of acute of chronic diseases

Exclusion Criteria:

conditions that do not meet the inclusion criteria listed.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

22 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shenxu Wang, MD	No. 150 Central Hospital of PLA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
No. 150 Central hospital of Chinese People's Liberation Army		Luoyang	Henan	471000	China

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided