- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958333
Muscular and Metabolic Adaptations to Exercise to Benefit High-Risk Workforce
January 30, 2017 updated by: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia
The Effects of Medium-Term Exercise Program on Health-Related Physical Fitness and Biochemical Outcomes in High-Risk Employees
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Exercise programs (e.g.
low-intensity, medium-intensity, high-intensity) consist of aerobic workout, strength training and flexibility exercise, with different program has different intensity, volume, frequency and duration of exercise.
Study Type
Interventional
Enrollment (Actual)
2114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Belgrade, Serbia, 11000
- Center for Health, Exercise and Sport Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- over 18 years of age
Exclusion Criteria:
- no diseases of musculoskeletal system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise 1
Low-intensity, low-volume cardiorespiratory exercise and strength training
|
Low-intensity, low-volume cardiorespiratory exercise and strength training
|
|
Experimental: Exercise 2
Medium-intensity, medium-volume cardiorespiratory exercise and strength training
|
Medium-intensity, Medium-volume cardiorespiratory exercise and strength training
|
|
Experimental: Exercise 3
High-intensity, High-volume cardiorespiratory exercise and strength training
|
High-intensity, High-volume cardiorespiratory exercise and strength training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiorespiratory endurance
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscular endurance
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscular strength
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
|
Body composition
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
|
Flexibility
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
|
AHA/ACSM risk score
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
|
PAR-Q score
Time Frame: Baseline and 6 months after intervention
|
Baseline and 6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Smith K. Evaluation of a stretching program to increase worker flexibility. Workplace Health Saf. 2013 Aug;61(8):329-32. doi: 10.1177/216507991306100802.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 29, 2013
First Submitted That Met QC Criteria
October 8, 2013
First Posted (Estimate)
October 9, 2013
Study Record Updates
Last Update Posted (Estimate)
February 1, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 01-300613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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