Predictors of Individual Training Effectiveness in Preven... | NCT00934206

Studies
Predictors of Individual Training Effectiveness in Preventive Exercise

NCT00934206

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Aug 26, 2011Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Primary Prevention

Interventions

Endurance training

Countries

Germany

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 2011

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

Aug 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 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

Aug 25, 2011

Last Update Posted Date

Aug 26, 2011Estimated

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

Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Yet, the extent of individual benefit differs considerably even within homogenous groups and the prediction of individual training effectiveness is not yet possible. This study aims to find predictors of individual training effectiveness.

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

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Experimental	One month of endurance training (running / walking at 60 % heart rate reserve for 45 min 4 times per week)	Behavioral: Endurance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance training	Behavioral	running / walking at 60 % heart rate reserve 4 times per week for 4 weeks	Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation of possible predictors with training effects on cardiovascular risk factors		within study periode

Secondary Outcomes

Measure	Description	Time Frame
Correlation of possible predictors with improvements in physical performance		within study period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects
age 35-60

Exclusion Criteria:

Any medical condition requiring medication (except thyroid hormones)
Other complaints that might interfere with exercise

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Krieg, M.D.	Institute of Sports- and Preventive Medicine, Saarland University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Sports- and Preventive Medicine, Saarland University		Saarbrücken	Saarland	66123	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24278393	Derived	Hecksteden A, Grutters T, Meyer T. Associations between acute and chronic effects of exercise on indicators of metabolic health: a pilot training trial. PLoS One. 2013 Nov 21;8(11):e81181. doi: 10.1371/journal.pone.0081181. eCollection 2013.

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care