NCT01676870

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

8 years

First QC Date

August 29, 2012

Last Update Submit

February 6, 2020

Conditions

Metabolic Syndrome

Keywords

exercise trainingexercise therapyphysical fitnessrisk factors

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

1x4 aerobic interval training

EXPERIMENTAL

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

Behavioral: 1x4 aerobic interval training

4x4 aerobic interval training

EXPERIMENTAL

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

Behavioral: 4x4 aerobic interval training

traditional moderate training

ACTIVE COMPARATOR

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

Behavioral: traditional moderate training

Interventions

1x4 aerobic interval trainingBEHAVIORAL

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.

1x4 aerobic interval training
4x4 aerobic interval trainingBEHAVIORAL

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.

4x4 aerobic interval training
traditional moderate trainingBEHAVIORAL

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).

traditional moderate training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • metabolic syndrome defined according to the IDF-criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

School of Human Movement Studies, University of Queensland

Saint Lucia, Australia

Location

University of Sao Paulo

São Paulo, Brazil

Location

KJ Fisioterapi

Guayaquil, Ecuador

Location

Internal Medicine, Cardiology, Sports Medicine Chair Dep. Prevention, Rehabilitation and Sports Medicine Faculty of Medicine University Hospital

Munich, Germany

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olavs hospital

Trondheim, Norway

Location

Related Publications (4)

  • 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.

    PMID: 29609582BACKGROUND

  • 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.

    PMID: 34951682DERIVED

  • 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.

    PMID: 28846513DERIVED

  • 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.

    PMID: 27480182DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ulrik Wisløff, PhD prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

January 1, 2012

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

EC(1)BR(1)AU(1)DE(1)NO(2)