Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
training
Control
Arm Description
12 weeks (2 x 6 weeks) of combined exercise training programme (supervised)
Continued usual care, habitual lifestyle
Outcomes
Primary Outcome Measures
insulin sensitivity (insulin profile)
glucose and insulin concentration measurements in blood during oral glucose tolerance test
Secondary Outcome Measures
Exercise tolerance
maximal cardiopulmonary exercise test on a bicycle ergometer
HbA1c, blood lipids, BNP
Muscle strength
maximal strength and strength endurance tested on a isokinetic dynamometer
Body composition
dual energy x-ray absorptiometry
cardiac function
echocardiography
Health-related quality of life
MLHFQ and Eq5d
Full Information
NCT ID
NCT02000479
First Posted
November 27, 2013
Last Updated
December 8, 2013
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02000479
Brief Title
Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure
Official Title
Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
training
Arm Type
Experimental
Arm Description
12 weeks (2 x 6 weeks) of combined exercise training programme (supervised)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continued usual care, habitual lifestyle
Intervention Type
Other
Intervention Name(s)
training
Other Intervention Name(s)
12 weeks of combined exercise training
Primary Outcome Measure Information:
Title
insulin sensitivity (insulin profile)
Description
glucose and insulin concentration measurements in blood during oral glucose tolerance test
Time Frame
change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Exercise tolerance
Description
maximal cardiopulmonary exercise test on a bicycle ergometer
Time Frame
change from baseline to 12 weeks
Title
HbA1c, blood lipids, BNP
Time Frame
change from baseline to 12 weeks
Title
Muscle strength
Description
maximal strength and strength endurance tested on a isokinetic dynamometer
Time Frame
change from baseline to 12 weeks
Title
Body composition
Description
dual energy x-ray absorptiometry
Time Frame
change from baseline to 12 weeks
Title
cardiac function
Description
echocardiography
Time Frame
change from baseline to 12 weeks
Title
Health-related quality of life
Description
MLHFQ and Eq5d
Time Frame
change from baseline to 12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Stevens, dra.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure
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