Clinical Trials Directory

Trials / Completed

CompletedNCT01206725

Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

The Effect of Aerobic Interval Training on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Norwegian University of Science and Technology · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Accepted

Summary

The aim of the study is to compare the effects of aerobic interval training and the IDF recommendations on physical activity on cardiac function and CV risk factors in patients with diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in patients with subclinical LV disease, improve both endothelial function and VO2max and thus reducing CV risk factors and CV disease. HbA1c will be more stable. The aims of this study are to address the exercise prescription recommendations for patients with (T2DM) who have subclinical heart disease. The prescription recommendations will be assessed by randomising T2DM patients with subclinical heart disease to one of the following 2 groups for 3 months followed by a 9 month home-based program: Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise recommendations of the International Diabetes Federation. Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.

Detailed description

The investigators primary hypotheses are that in patients with type 2 diabetes and subclinical heart disease: Moderate Intensity Exercise will: Not significantly improve myocardial function compared to controls, Despite significant improvement (compared to controls) in: Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA) Aerobic Interval Training Group will: Significantly improve myocardial function compared to controls, Significantly improve (compared to moderate intensity exercise group): Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)

Conditions

Interventions

TypeNameDescription
OTHERExercise1. Moderate Intensity Exercise Group (ME). Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training. 2. Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.The exercise starts with warming-up for 10-min at 70% of HRmax before performing 4x4min intervals at 90-95% of HRmax, with 3-min active recovery at 70% of HRmax between each interval, and a 5-min cool-down period, giving a total of 40-min.

Timeline

Start date
2010-09-01
Primary completion
2012-11-01
Completion
2013-05-01
First posted
2010-09-22
Last updated
2018-01-05

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01206725. Inclusion in this directory is not an endorsement.