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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01676870




Registration number
NCT01676870
Ethics application status
Date submitted
29/08/2012
Date registered
31/08/2012
Date last updated
7/02/2020

Titles & IDs
Public title
Exercise in Prevention of Metabolic Syndrome
Scientific title
Exercise in Prevention of Metabolic Syndrome
Secondary ID [1] 0 0
2011/1230
Universal Trial Number (UTN)
Trial acronym
EX-MET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - 1x4 aerobic interval training
BEHAVIORAL - 4x4 aerobic interval training
BEHAVIORAL - traditional moderate training

Experimental: 1x4 aerobic interval training - 1x4min aerobic interval training (1-AIT), 3 times a week

Experimental: 4x4 aerobic interval training - 4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week

Active comparator: traditional moderate training - traditional moderate training (CME), moderate exercise at least 30 min, 5 days a week or more, according to today's guidelines


BEHAVIORAL: 1x4 aerobic interval training
endurance training as walking/running "uphill" 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 5min cool-down.

BEHAVIORAL: 4x4 aerobic interval training
endurance training as walking/running "uphill" 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 3 min active pause between each interval, 5min cool-down.

BEHAVIORAL: traditional moderate training
moderate intensity treadmill training (50-70% of HRmax) for a minimum of 30min, 5 times a week for 16 weeks (2 supervised sessions and 3 or more home).
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
cardiovascular risk factors constituting metabolic syndrome
Timepoint [1] 0 0
up to 3 years

Eligibility
Key inclusion criteria
* metabolic syndrome defined according to the IDF-criteria
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* unstable angina
* recent cardiac infarction (4weeks)
* uncompensated heart failure
* severe valvular illness
* pulmonary disease
* uncontrolled hypertension
* kidney failure
* orthopedic/neurological limitations
* cardiomyopathy
* planned operations during the research period
* reluctant to sign the consent form
* drug or alcohol abuse
* participants in a parallel study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2019
Sample size
Target
Accrual to date
Final
408
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Human Movement Studies, University of Queensland - St Lucia
Recruitment postcode(s) [1] 0 0
- St Lucia
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
São Paulo
Country [2] 0 0
Ecuador
State/province [2] 0 0
Guayaquil
Country [3] 0 0
Germany
State/province [3] 0 0
Munich
Country [4] 0 0
Norway
State/province [4] 0 0
Stavanger
Country [5] 0 0
Norway
State/province [5] 0 0
Trondheim

Funding & Sponsors
Primary sponsor type
Other
Name
Norwegian University of Science and Technology
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Helse Stavanger HF
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Technical University of Munich
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of Queensland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
KJ Fisiosport
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Sao Paulo
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ulrik Wisløff, PhD prof
Address 0 0
Norwegian University of Science and Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01676870