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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Behaviour - 1x4 aerobic interval training
Behaviour - 4x4 aerobic interval training
Behaviour - 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


Behaviour: 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.

Behaviour: 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.

Behaviour: 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
Behaviour
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
Other
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
The primary objective of the study is to compare in a real-world setting the efficacy of
traditional training (today's guideline, vigorously or moderate exercise) and amount of
aerobic interval training (1-AIT) in reduction of risk factors constituting metabolic
syndrome.

The secondary objective is to compare the efficacy of traditional moderate training (today's
guideline) and amount of aerobic interval training (1-AIT vs. 4-AIT) in improving aerobic
capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle
energy metabolism, left ventricle systolic and diastolic function at rest and right
ventricular function.

The investigators hypothesized that aerobic interval training would reverse features of the
metabolic syndrome more than traditional training.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01676870
Trial related presentations / publications
Tjonna AE, Ramos JS, Pressler A, Halle M, Jungbluth K, Ermacora E, Salvesen O, Rodrigues J, Bueno CR Jr, Munk PS, Coombes J, Wisloff U. EX-MET study: exercise in prevention on of metabolic syndrome - a randomized multicenter trial: rational and design. BMC Public Health. 2018 Apr 2;18(1):437. doi: 10.1186/s12889-018-5343-7.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01676870