Gene - Exercise Research Study | NCT00976742

Studies
Gene - Exercise Research Study

NCT00976742

Sponsor

University of Maryland, College Park

Status

Completed

Last Update Posted

Apr 3, 2025Actual

Enrollment

225Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease Risk Factors

Interventions

Endurance exercise training

Countries

United States

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

Mar 2025

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

Jun 1998

Primary Completion Date

Dec 2004Actual

Completion Date

Not provided

First Submitted Date

Sep 11, 2009

First Submission Date that Met QC Criteria

Sep 11, 2009

First Posted Date

Sep 14, 2009Estimated

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

Mar 31, 2025

Last Update Posted Date

Apr 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jim Hagberg, Professor, University of Maryland, College ParkPrincipal Investigator

Lead Sponsor

University of Maryland, College ParkOTHER

Collaborators

Name	Class
University of Pittsburgh	OTHER
University of Maryland, Baltimore	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 investigators hypothesize that the degree to which older generally healthy but sedentary men and women improve a number of cardiovascular (CV) disease risk factors with 6 months of highly-standardized endurance exercise training will be a function of common genetic variations in candidate genes.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endurance Exercise Training	Experimental		Behavioral: Endurance exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance exercise training	Behavioral		Endurance Exercise Training

Measure	Description	Time Frame
Cardiovascular Disease Risk Factors		~9 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

generally healthy
free from CV disease
ability to undergo exercise training

Exclusion Criteria:

previous history of CV disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland Dept of Kinesiology		College Park	Maryland	20742-2611	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17378998	Result	Halverstadt A, Phares DA, Wilund KR, Goldberg AP, Hagberg JM. Endurance exercise training raises high-density lipoprotein cholesterol and lowers small low-density lipoprotein and very low-density lipoprotein independent of body fat phenotypes in older men and women. Metabolism. 2007 Apr;56(4):444-50. doi: 10.1016/j.metabol.2006.10.019.

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases