Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure

The purpose of this study is to investigate the effects of a combined training programme on insulin resistance, exercise tolerance, muscle strength, body composition and cardiac function in chronic heart failure patients.

It is assumed that the above mentioned clinical parameters will improve due to physical exercise.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: training

Detailed Description

1. Background and study aims During the last decades, the prevalence of (pre)diabetes but also of chronic heart failure (CHF) has increased dramatically. Somehow, both conditions are linked, but the mechanisms involved have not been completely clarified yet. It is clear that the presence of (pre)diabetes in CHF patients affects morbidity and mortality. Although feasibility, safety and beneficial effects of exercise training in CHF are generally acknowledged, its effects on insulin resistance are not well understood. Therefore, the presented study aims to investigate the effect of ET on insulin resistance and the possible link with cardiac function, exercise tolerance, muscle strength and body composition in CHF patients.

2. What does the study involve?

   A randomized controlled study (n=30) will be performed over a period of 12 weeks. Following study inclusion, baseline measurements will be performed in 1 week. They include:

   • a maximal exercise test on a bicycle ergometer to assess exercise tolerance,
   • two oral glucose tolerance tests to assess fasting and post-exercise insulin resistance,
   • a venous blood sample to determine HbA1c, blood lipids, BNP,
   • a muscle strength measurement on a isokinetic dynamometer,
   • assessment of body composition via dual energy x-ray absorptiometry,
   • cardiac echography,
   • questionnaires to assess health-related quality of life,
   • a questionnaire (IPAQ) and a pedometer (3 days) to assess physical activity. Following baseline measurements, subjects will be randomized to a control group (CON, n=10) and an exercise intervention group (EX, n=20), matching for gender and reduced/preserved ejection fraction and glucose tolerance. Hereafter, CON will receive usual care and will be advised to maintain their normal lifestyle, EX subjects will be enrolled in a 12-week training program. Following 6 (MID) and 12 (POST) weeks of exercise training including progressive training load adaptations, baseline measurements will be repeated in all patients.

3. What are the possible benefits and risks of participating?

   • Benefits: patients receive a free training program with personal and professional supervision. After completing the study, they receive a report with personal results and evaluation of training effects.
   • Risks: the usual risks of exercise tolerance testing and exercise training in a CHF population are limited because training sessions are held in the supervised conditions of the Jessa hospital and because training characteristics are according to guidelines of the European Society of Cardiology. Exposure to x-rays during body composition assessment is very low, almost negligible.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of chronic heart failure for at least 6 months
• clinically stable (not hospitalized) for more than 3 months prior to the onset of the study
• optimal medical therapy.

Exclusion Criteria:

• any contra-indication for exercise therapy,
• glucose lowering medical therapy,
• active lifestyle with regular physical activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: training; 12 weeks (2 x 6 weeks) of combined exercise training programme (supervised)	Other: training; Other Names: 12 weeks of combined exercise training
No Intervention: Control; Continued usual care, habitual lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin sensitivity (insulin profile)	glucose and insulin concentration measurements in blood during oral glucose tolerance test	change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise tolerance	maximal cardiopulmonary exercise test on a bicycle ergometer	change from baseline to 12 weeks
HbA1c, blood lipids, BNP		change from baseline to 12 weeks
Muscle strength	maximal strength and strength endurance tested on a isokinetic dynamometer	change from baseline to 12 weeks
Body composition	dual energy x-ray absorptiometry	change from baseline to 12 weeks
cardiac function	echocardiography	change from baseline to 12 weeks
Health-related quality of life	MLHFQ and Eq5d	change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Study Chair: An Stevens, dra., Hasselt University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 8, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Heart Failure; Insulin Resistance
• Other Study ID Numbers: 11.11/cardio11.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No