Clinical trial NCT01676870: Exercise in Prevention of Metabolic Syndrome
Official title: Exercise in Prevention of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: exercise training
exercise therapy
physical fitness
risk factors
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Technical University of Munich
name: The University of Queensland
name: KJ Fisiosport
name: University of Sao Paulo
First posted: 2012-08-31
Enrollment: 408
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiovascular risk factors constituting metabolic syndrome
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: St Lucia
country: Australia
facility: School of Human Movement Studies, University of Queensland
city: São Paulo
country: Brazil
facility: University of Sao Paulo
city: Guayaquil
country: Ecuador
facility: KJ Fisioterapi
city: Munich
country: Germany
facility: Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St. Olavs hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, PhD prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ramos JS, Dalleck LC, Fennell M, Martini A, Welmans T, Stennett R, Keating SE, Fassett RG, Coombes JS. Exercise Training Intensity and the Fitness-Fatness Index in Adults with Metabolic Syndrome: A Randomized Trial. Sports Med Open. 2021 Dec 24;7(1):100. doi: 10.1186/s40798-021-00395-7.
citation: Ramos JS, Dalleck LC, Borrani F, Beetham KS, Wallen MP, Mallard AR, Clark B, Gomersall S, Keating SE, Fassett RG, Coombes JS. Low-Volume High-Intensity Interval Training Is Sufficient to Ameliorate the Severity of Metabolic Syndrome. Metab Syndr Relat Disord. 2017 Sep;15(7):319-328. doi: 10.1089/met.2017.0042. Epub 2017 Jun 22.
citation: Ramos JS, Dalleck LC, Borrani F, Mallard AR, Clark B, Keating SE, Fassett RG, Coombes JS. The effect of different volumes of high-intensity interval training on proinsulin in participants with the metabolic syndrome: a randomised trial. Diabetologia. 2016 Nov;59(11):2308-2320. doi: 10.1007/s00125-016-4064-7. Epub 2016 Aug 1.