Sedentary LifestyleNCT01958333
Muscular and Metabolic Adaptations to Exercise to Benefit High-Risk Workforce
A study testing Exercise 1, Exercise 2 and Exercise 3 in people with Sedentary Lifestyle, run by Center for Health Sciences, Serbia at 1 site in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Exercise 1, Exercise 2 and Exercise 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,114 participants
- Where
- 1 siteSerbia
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years of age
Who cannot join
- no diseases of musculoskeletal system
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Center for Health, Exercise and Sport Sciences
Belgrade, Serbia, 11000
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Exercise 1, Exercise 2, Exercise 3
- Keywords
- Health-Related Physical Fitness, Aerobic Endurance, Muscular Endurance, Flexibility
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise 1Procedure or surgery
Low-intensity, low-volume cardiorespiratory exercise and strength training
Exercise 2Procedure or surgery
Medium-intensity, Medium-volume cardiorespiratory exercise and strength training
Exercise 3Procedure or surgery
High-intensity, High-volume cardiorespiratory exercise and strength training
| Study group | Role | What they receive |
|---|---|---|
| Exercise 1 | Experimental | Low-intensity, low-volume cardiorespiratory exercise and strength training Receives: Procedure: Exercise 1 |
| Exercise 2 | Experimental | Medium-intensity, medium-volume cardiorespiratory exercise and strength training Receives: Procedure: Exercise 2 |
| Exercise 3 | Experimental | High-intensity, High-volume cardiorespiratory exercise and strength training Receives: Procedure: Exercise 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory endurance
Measured: Baseline and 6 months after intervention
Secondary outcomes (1)
Muscular endurance
Measured: Baseline and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Health Sciences, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health Sciences, Serbia
- Investigators
- Sergej M Ostojic, MD, PhD, Principal investigator, Center for Health, Exercise and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958333
- Sponsor's protocol ID
- 01-300613
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 24053219Smith K. Evaluation of a stretching program to increase worker flexibility. Workplace Health Saf. 2013 Aug;61(8):329-32. doi: 10.1177/216507991306100802.
PubMed 23930658Birdee 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.
PubMed 23618884
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Medium-Term Exercise Program on Health-Related Physical Fitness and Biochemical Outcomes in High-Risk Employees
- ClinicalTrials.gov ID
- NCT01958333
- Acronym / sponsor ID
- 01-300613
- Conditions
- Sedentary Lifestyle
- Keywords
- Health-Related Physical Fitness, Aerobic Endurance, Muscular Endurance, Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,114 participants (actual)
- Lead sponsor
- Center for Health Sciences, SerbiaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise 1 | Experimental | Procedure: Exercise 1Low-intensity, low-volume cardiorespiratory exercise and strength training |
| Exercise 2 | Experimental | Procedure: Exercise 2Medium-intensity, medium-volume cardiorespiratory exercise and strength training |
| Exercise 3 | Experimental | Procedure: Exercise 3High-intensity, High-volume cardiorespiratory exercise and strength training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 18 years of age
Key exclusion criteria (1 listed)
- no diseases of musculoskeletal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise 1Low-intensity, low-volume cardiorespiratory exercise and strength training | Procedure or surgery | Exercise 1 |
| Exercise 2Medium-intensity, Medium-volume cardiorespiratory exercise and strength training | Procedure or surgery | Exercise 2 |
| Exercise 3High-intensity, High-volume cardiorespiratory exercise and strength training | Procedure or surgery | Exercise 3 |
Primary outcome
Cardiorespiratory endurance
Time frame: Baseline and 6 months after intervention
1 secondary outcome
Muscular endurance
Time frame: Baseline and 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 24053219Andres 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.
- Background: PubMed 23930658Smith K. Evaluation of a stretching program to increase worker flexibility. Workplace Health Saf. 2013 Aug;61(8):329-32. doi: 10.1177/216507991306100802.
- Background: PubMed 23618884Birdee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergej M Ostojic, MD, PhD principal investigator
Center for Health, Exercise and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise 1, Exercise 2 and Exercise 3 in people with Sedentary Lifestyle, run by Center for Health Sciences, Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory endurance (time frame: Baseline and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958333, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.