ObesityNCT00218920
Effective Training in Overweight and Obese People
A study testing Strength training, continuous moderate-intensity aerobic training and high-intensity interval aerobic training in people with Obesity and Overweight, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim is to come to a consensus about how to prescribe exercise training that actually helps overweight and obese people. Thus, the present study determines the effects of several types of exercise training to define the one with the largest effect with the least effort. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Strength training, continuous moderate-intensity aerobic training and high-intensity interval aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Jan 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) over 30
Who cannot join
- Not able to walk on a treadmill
- Participating in an other study
- Serious cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective Training in Overweight and Obesity
The aim is to come to a consensus about how to prescribe exercise training that actually helps overweight and obese people. Thus, the present study determines the effects of several types of exercise training to define the one with the largest effect with the least effort.
- Conditions
- Obesity, Overweight
- Being tested
- Strength training, continuous moderate-intensity aerobic training, high-intensity interval aerobic training
- Keywords
- aerobic capacity, endothelial function, exercise
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
a strength training regime of 4 series with 5 repetitions each, at approximately 90% of 1 repetition maximum (RM), in a leg press apparatus to develop maximal strength mainly from neural adaptation with minimal weight gain due to muscular hypertrophy.
continuous moderate-intensity aerobic trainingBehavioural
The moderate-intensity group walked continuously for 47 min at 60-70% of maximum heart rate (HRmax) to ensure that the training protocols were isocaloric.
high-intensity interval aerobic trainingBehavioural
High-intensity training consisted of a 10 min warm-up period at 50-60% of HRmax [maximal HR (heart rate)], followed by 4×4-min intervals at 85-95% of HRmax with 3 min active breaks in between the intervals, consisting of walking or jogging at 50-60% of HRmax. The exercise session was terminated by a 5 min cool-down period.
| Study group | Role | What they receive |
|---|---|---|
| strength training | Experimental | Over a 12-week period, 13 subjects performed three programmed exercise sessions per week; two supervised by the study investigators in the research laboratory and one performed at home or in a gym, according to instructions. Receives: Behavioral: Strength training |
| continuous moderate-intensity aerobic training | Experimental | Over a 12-week period, 13 subjects performed three programmed exercise sessions per week; two supervised by the study investigators in the research laboratory and one performed at home or in a gym, according to instructions. Receives: Behavioral: continuous moderate-intensity aerobic training |
| high-intensity interval aerobic training | Experimental | Over a 12-week period, 14 subjects performed three programmed exercise sessions per week; two supervised by the study investigators in the research laboratory and one performed at home or in a gym, according to instructions. Receives: Behavioral: high-intensity interval aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 12 weeks
Aerobic capacity
Measured: 12 weeks
Endothelial function
Measured: 12 weeks
Secondary outcomes (1)
Molecular markers in fat and skeletal muscle biopsies for the effects of exercise training
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
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 ObesityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218920
- Sponsor's protocol ID
- 4-2005.542
- Status last verified
- Oct 2017
- First submitted
- 20 Sep 2005
- Last updated
- 16 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schjerve IE, Tyldum GA, Tjonna AE, Stolen T, Loennechen JP, Hansen HE, Haram PM, Heinrich G, Bye A, Najjar SM, Smith GL, Slordahl SA, Kemi OJ, Wisloff U. Both aerobic endurance and strength training programmes improve cardiovascular health in obese adults. Clin Sci (Lond). 2008 Nov;115(9):283-93. doi: 10.1042/CS20070332.
PubMed 18338980
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Training in Overweight and Obesity
- ClinicalTrials.gov ID
- NCT00218920
- Acronym / sponsor ID
- 4-2005.542
- Conditions
- Obesity, Overweight
- Keywords
- aerobic capacity, endothelial function, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Sep 2005 (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 aim is to come to a consensus about how to prescribe exercise training that actually helps overweight and obese people. Thus, the present study determines the effects of several types of exercise training to define the one with the largest effect with the least effort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| strength training | Experimental | Behavioral: Strength trainingOver a 12-week period, 13 subjects performed three programmed exercise sessions per week; two supervised by the study investigators in the research laboratory and one performed at home or in a gym, according to instructions. |
| continuous moderate-intensity aerobic training | Experimental | Behavioral: continuous moderate-intensity aerobic trainingOver a 12-week period, 13 subjects performed three programmed exercise sessions per week; two supervised by the study investigators in the research laboratory and one performed at home or in a gym, according to instructions. |
| high-intensity interval aerobic training | Experimental | Behavioral: high-intensity interval aerobic trainingOver a 12-week period, 14 subjects performed three programmed exercise sessions per week; two supervised by the study investigators in the research laboratory and one performed at home or in a gym, according to instructions. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) over 30
Key exclusion criteria (3 listed)
- Not able to walk on a treadmill
- Participating in an other study
- Serious cardiovascular diseases
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 |
|---|---|---|
| Strength traininga strength training regime of 4 series with 5 repetitions each, at approximately 90% of 1 repetition maximum (RM), in a leg press apparatus to develop maximal strength mainly from neural adaptation with minimal weight gain due to muscular hypertrophy. | Behavioural | strength training |
| continuous moderate-intensity aerobic trainingThe moderate-intensity group walked continuously for 47 min at 60-70% of maximum heart rate (HRmax) to ensure that the training protocols were isocaloric. | Behavioural | continuous moderate-intensity aerobic training |
| high-intensity interval aerobic trainingHigh-intensity training consisted of a 10 min warm-up period at 50-60% of HRmax [maximal HR (heart rate)], followed by 4×4-min intervals at 85-95% of HRmax with 3 min active breaks in between the intervals, consisting of walking or jogging at 50-60% of HRmax. The exercise session was terminated by a 5 min cool-down period. | Behavioural | high-intensity interval aerobic training |
Primary outcome
Body weight
Time frame: 12 weeks
Aerobic capacity
Time frame: 12 weeks
Endothelial function
Time frame: 12 weeks
1 secondary outcome
Molecular markers in fat and skeletal muscle biopsies for the effects of exercise training
Time frame: 12 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 16 Oct 2017.
- Results publication: PubMed 18338980Schjerve IE, Tyldum GA, Tjonna AE, Stolen T, Loennechen JP, Hansen HE, Haram PM, Heinrich G, Bye A, Najjar SM, Smith GL, Slordahl SA, Kemi OJ, Wisloff U. Both aerobic endurance and strength training programmes improve cardiovascular health in obese adults. Clin Sci (Lond). 2008 Nov;115(9):283-93. doi: 10.1042/CS20070332.
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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.
Ulrik Wisløff, phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training, continuous moderate-intensity aerobic training and high-intensity interval aerobic training in people with Obesity and Overweight, 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 1 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 16 Oct 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?
Body weight (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT00218920, 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 16 Oct 2017.