Healthy SubjectsNEATNCT01313468
Interval Training and Resting Metabolism
A study testing 1 x 4 minute interval, 4 x 4 minutes Intervals and Moderate continuous Training in people with Healthy Subjects, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
It has been reported that obese individuals are seated 2 ½ hour more than lean individuals and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between equal size people due to different occupational and leisure time activities. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- 1 x 4 minute interval, 4 x 4 minutes Intervals and Moderate continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to Nov 2011
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male gender
- Age 18-50
- BMI 25-30 kg x m2
- No significant comorbidities
- Abel to exercise
- Not partaking in organized physical activity
Who cannot join
- Inability to exercise due to musculoskeletal conditions
- Known ischemic cardiovascular disease
- High daily physical and occupational activity levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Interval Training on NEAT in Sedentary Men
It has been reported that obese individuals are seated 2 ½ hour more than lean individuals and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between equal size people due to different occupational and leisure time activities. The primary aim of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary men.
Subject will be randomized to three different training intervention, with 3 exercise session each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7 day period both before and after training.
- Conditions
- Healthy Subjects
- Being tested
- 1 x 4 minute interval, 4 x 4 minutes Intervals, Moderate continuous Training
- Keywords
- NEAT, maximal oxygen uptake, stroke volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 x 4 minute intervalBehavioural
1 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate
4 x 4 minutes IntervalsBehavioural
4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate.
Moderate continuous TrainingBehavioural
47 minutes of Moderate continuous Training
| Study group | Role | What they receive |
|---|---|---|
| 4 x 4 Interval | Experimental | 4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate. Receives: Behavioral: 4 x 4 minutes Intervals |
| 1 4 minutes interval | Experimental | 1 x 4 minutes intervals at 90-95% of HR max Receives: Behavioral: 1 x 4 minute interval |
| Moderate continuous Training | Experimental | 47 minutes of Moderate continuous Training Receives: Behavioral: Moderate continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
nonexercise activity thermogenesis
NEAT Will be measured using an activity sensor. Physical activity is recorded over a 7 day period. The energy equivalent of each of these activities is determined. The time spent in each activity is then multiplied by equivalent for the activity. The values are then summed to derive an estimate of NEAT.
Measured: Baseline and 10 weeks
Secondary outcomes (1)
Cardiopulmonary maximal oxygen uptake
The secondary aims are to investigate the changes in maximal oxygen uptake, heart function, and body composition in response to interval training
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Trine Karlsen, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313468
- Sponsor's protocol ID
- 2010/1541
- Acronym
- NEAT
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zisko N, Stensvold D, Hordnes-Slagsvold K, Rognmo O, Nauman J, Wisloff U, Karlsen T. Effect of Change in VO2max on Daily Total Energy Expenditure in a Cohort of Norwegian Men: A Randomized Pilot Study. Open Cardiovasc Med J. 2015 Apr 30;9:50-7. doi: 10.2174/1874192401509010050. eCollection 2015.
PubMed 25969700
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Interval Training on NEAT in Sedentary Men
- ClinicalTrials.gov ID
- NCT01313468
- Acronym / sponsor ID
- NEAT / 2010/1541
- Conditions
- Healthy Subjects
- Keywords
- NEAT, maximal oxygen uptake, stroke volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Feb 2011 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Mar 2011 (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.
It has been reported that obese individuals are seated 2 ½ hour more than lean individuals and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between equal size people due to different occupational and leisure time activities. The primary aim of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary men.
Subject will be randomized to three different training intervention, with 3 exercise session each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7 day period both before and after training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 x 4 Interval | Experimental | Behavioral: 4 x 4 minutes Intervals4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate. |
| 1 4 minutes interval | Experimental | Behavioral: 1 x 4 minute interval1 x 4 minutes intervals at 90-95% of HR max |
| Moderate continuous Training | Experimental | Behavioral: Moderate continuous Training47 minutes of Moderate continuous Training |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male gender
- Age 18-50
- BMI 25-30 kg x m2
- No significant comorbidities
- Abel to exercise
Key exclusion criteria (3 listed)
- Inability to exercise due to musculoskeletal conditions
- Known ischemic cardiovascular disease
- High daily physical and occupational activity levels
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 |
|---|---|---|
| 1 x 4 minute interval1 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate | Behavioural | 1 4 minutes interval |
| 4 x 4 minutes Intervals4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate. | Behavioural | 4 x 4 Interval |
| Moderate continuous Training47 minutes of Moderate continuous Training | Behavioural | Moderate continuous Training |
Primary outcome
nonexercise activity thermogenesis
Time frame: Baseline and 10 weeks
NEAT Will be measured using an activity sensor. Physical activity is recorded over a 7 day period. The energy equivalent of each of these activities is determined. The time spent in each activity is then multiplied by equivalent for the activity. The values are then summed to derive an estimate of NEAT.
1 secondary outcome
Cardiopulmonary maximal oxygen uptake
Time frame: Baseline and 10 weeks
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 30 Mar 2017.
- Results publication: PubMed 25969700Zisko N, Stensvold D, Hordnes-Slagsvold K, Rognmo O, Nauman J, Wisloff U, Karlsen T. Effect of Change in VO2max on Daily Total Energy Expenditure in a Cohort of Norwegian Men: A Randomized Pilot Study. Open Cardiovasc Med J. 2015 Apr 30;9:50-7. doi: 10.2174/1874192401509010050. eCollection 2015.
- 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.
Trine Karlsen principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 x 4 minute interval, 4 x 4 minutes Intervals and Moderate continuous Training in people with Healthy Subjects, run by Norwegian University of Science and Technology at 1 site in Norway.
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 6 inclusion and 3 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 30 Mar 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 Norway. 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?
nonexercise activity thermogenesis (time frame: Baseline and 10 weeks). 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 NCT01313468, which also lists 1 linked publication.
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 30 Mar 2017.