Exercise in Prevention of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— EX-MET  

Official title:

Exercise in Prevention of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676870
• Other study ID #: 2011/1230
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study describes a randomized multicenter clinical trial designed to test the hypothesis that a 16-week program, with one year follow up of vigorously exercise defined from today's guidelines (performed as 4-AIT (4x4min aerobe interval training)) yields larger beneficial effects in reducing risk factors constituting the metabolic syndrome than continuously moderate intensity exercise (CME) defined from today's guidelines.

Furthermore, the importance of the amount of aerobic interval training remains unclear and it is unknown how little "one can get away with" and still obtain substantial beneficial cardiovascular effects. Therefore, the investigators will also determine whether one bout of aerobe interval training (AIT) - 1-AIT = 1x4min aerobe interval training, can give beneficial effects compared to 4-AIT and CME.

Evaluation criteria are risk factors constituting metabolic syndrome, aerobic capacity measured as peak oxygen uptake and compliance to intervention. Assessments will be made before and after the 16-week program, and at six month, and 1 and 3 years follow-up. According to estimates based on data from previously studies, 3, 4 a total number of 465 patients randomized 1:1:1 to the three interventions gives 80% power to detect an effect of 4-AIT compared to 1-AIT/CME of 51% recovery versus 37% recovery from metabolic syndrome at the 5% significance level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• metabolic syndrome defined according to the IDF-criteria

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
Australia	School of Human Movement Studies, University of Queensland	St Lucia
Brazil	University of Sao Paulo	São Paulo
Ecuador	KJ Fisioterapi	Guayaquil
Germany	Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital	Munich
Norway	Stavanger University Hospital	Stavanger
Norway	St. Olavs hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Stavanger HF, KJ Fisiosport, Technische Universität München, The University of Queensland, University of Sao Paulo

Countries where clinical trial is conducted

Australia,  Brazil,  Ecuador,  Germany,  Norway, 

References & Publications (1)

Tjønna AE, Ramos JS, Pressler A, Halle M, Jungbluth K, Ermacora E, Salvesen Ø, Rodrigues J, Bueno CR Jr, Munk PS, Coombes J, Wisløff 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular risk factors constituting metabolic syndrome	Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma	up to 3 years