Exercise in Prevention of Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: traditional moderate training; Behavioral: 1x4 aerobic interval training; Behavioral: 4x4 aerobic interval training

• Registration Number: NCT01676870
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional moderate training	traditional moderate training	traditional moderate training (CME), moderate exercise at least 30 min, 5 days a week or more, according to today's guidelines
1x4 aerobic interval training	1x4 aerobic interval training	1x4min aerobic interval training (1-AIT), 3 times a week
4x4 aerobic interval training	4x4 aerobic interval training	4x4min aerobic interval training (4-AIT), vigorously exercise according to today's guidelines, 3 times a week

Primary Outcome Measures

Name	Time	Method
cardiovascular risk factors constituting metabolic syndrome	up to 3 years	Endothelial function and blood pressure, biopsies from the m. vastus lateralis, Protein and expression levels, oxidized LDL and adiponectin in blood plasma

Trial Locations

Locations (6)

St. Olavs hospital; 🇳🇴 Trondheim, Norway

University of Sao Paulo; 🇧🇷 São Paulo, Brazil

School of Human Movement Studies, University of Queensland; 🇦🇺 St Lucia, Australia

Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital; 🇩🇪 Munich, Germany

KJ Fisioterapi; 🇪🇨 Guayaquil, Ecuador

Stavanger University Hospital; 🇳🇴 Stavanger, Norway