NCT01958333

Brief Summary

The purpose of this study is to investigate the effects of three different exercise programs (e.g. low-intensity, medium-intensity, high-intensity) administered for six months on health-related physical fitness, biochemical variables and general health outcomes in high-risk employees, with about 2000 volunteers will participate in the randomized and repeated-measure study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,114

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.5 years

First QC Date

September 29, 2013

Last Update Submit

January 30, 2017

Conditions

Sedentary Lifestyle

Keywords

Health-Related Physical FitnessAerobic EnduranceMuscular EnduranceFlexibility

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory endurance

    Baseline and 6 months after intervention

Secondary Outcomes (1)

  • Muscular endurance

    Baseline and 6 months after intervention

Other Outcomes (5)

  • Muscular strength

    Baseline and 6 months after intervention

  • Body composition

    Baseline and 6 months after intervention

  • Flexibility

    Baseline and 6 months after intervention

  • +2 more other outcomes

Study Arms (3)

Exercise 1

EXPERIMENTAL

Low-intensity, low-volume cardiorespiratory exercise and strength training

Procedure: Exercise 1

Exercise 2

EXPERIMENTAL

Medium-intensity, medium-volume cardiorespiratory exercise and strength training

Procedure: Exercise 2

Exercise 3

EXPERIMENTAL

High-intensity, High-volume cardiorespiratory exercise and strength training

Procedure: Exercise 3

Interventions

Exercise 1PROCEDURE

Low-intensity, low-volume cardiorespiratory exercise and strength training

Exercise 1
Exercise 2PROCEDURE

Medium-intensity, Medium-volume cardiorespiratory exercise and strength training

Exercise 2
Exercise 3PROCEDURE

High-intensity, High-volume cardiorespiratory exercise and strength training

Exercise 3

Eligibility Criteria

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

You may qualify if:

  • over 18 years of age

You may not qualify if:

  • no diseases of musculoskeletal system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, 11000, Serbia

Location

Related Publications (3)

  • Andres KL, Renn TA, Gray DA, Englund JM, Olsen GW, Letourneau BK. Evaluation of a cardiovascular Risk Reduction Program at a workplace medical clinic. Workplace Health Saf. 2013 Oct;61(10):459-66; quiz 467. doi: 10.1177/216507991306101006. Epub 2013 Sep 23.

    PMID: 24053219BACKGROUND

  • Smith K. Evaluation of a stretching program to increase worker flexibility. Workplace Health Saf. 2013 Aug;61(8):329-32. doi: 10.1177/216507991306100802.

    PMID: 23930658BACKGROUND

  • Birdee GS, Byrne DW, McGown PW, Rothman RL, Rolando LA, Holmes MC, Yarbrough MI. Relationship between physical inactivity and health characteristics among participants in an employee-wellness program. J Occup Environ Med. 2013 May;55(5):514-9. doi: 10.1097/JOM.0b013e31827f37d7.

    PMID: 23618884BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sergej M Ostojic, MD, PhD

    Center for Health, Exercise and Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Exercise Physiology Laboratory

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 9, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)