Worksite Exercise Intervention Effects on Cardiovascular... | NCT02260232

Studies
Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees

NCT02260232

Sponsor

Universidad Europea de Madrid

Status

Completed

Last Update Posted

Oct 9, 2014Estimated

Enrollment

295Actual

Phase

Not Applicable

Conditions

Exercise Therapy

Interventions

exercise training

Countries

Not provided

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

Oct 2014

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 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Oct 6, 2014

First Submission Date that Met QC Criteria

Oct 6, 2014

First Posted Date

Oct 9, 2014Estimated

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

Oct 6, 2014

Last Update Posted Date

Oct 9, 2014Estimated

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

Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance.

Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104 men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical activity levels were assessed by the long self-administrated version of the International Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were collected from participants at baseline survey, at 6 months and 1-year after. Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.

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

295Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise intervention	Experimental	Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.	Other: exercise training
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise training	Other		exercise intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International Physical Activity Questionnaire-Long Form (IPAQ-L)		1 week
Graded cardiorespiratory fitness exercise test		1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Working in ASISA company, middle-age (20-60)

Exclusion Criteria:

No medical condition contraindicating exercise participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

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