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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
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 27, 2013
    Last Updated
    December 8, 2013
    Sponsor
    Hasselt University
    Collaborators
    Jessa Hospital
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    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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