Chronic Heart FailureNCT02000479
Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure
A study testing training in people with Chronic Heart Failure, run by Hasselt University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any contra-indication for exercise therapy,
- glucose lowering medical therapy,
- active lifestyle with regular physical activity.
About this study
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.
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingOther
Also called 12 weeks of combined exercise training
| Study group | Role | What they receive |
|---|---|---|
| training | Experimental | 12 weeks (2 x 6 weeks) of combined exercise training programme (supervised) Receives: Other: training |
| Control | No intervention | Continued usual care, habitual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity (insulin profile)
glucose and insulin concentration measurements in blood during oral glucose tolerance test
Measured: change from baseline to 12 weeks
Secondary outcomes (6)
Exercise tolerance
maximal cardiopulmonary exercise test on a bicycle ergometer
Measured: change from baseline to 12 weeks
HbA1c, blood lipids, BNP
Measured: change from baseline to 12 weeks
Muscle strength
maximal strength and strength endurance tested on a isokinetic dynamometer
Measured: change from baseline to 12 weeks
Body composition
dual energy x-ray absorptiometry
Measured: change from baseline to 12 weeks
cardiac function
echocardiography
Measured: change from baseline to 12 weeks
Health-related quality of life
MLHFQ and Eq5d
Measured: change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- An Stevens, dra., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000479
- Sponsor's protocol ID
- 11.11/cardio11.01
- Status last verified
- Dec 2013
- First submitted
- 27 Nov 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Exercise Therapy on Insulin Resistance in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02000479
- Acronym / sponsor ID
- 11.11/cardio11.01
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training | Experimental | Other: training12 weeks (2 x 6 weeks) of combined exercise training programme (supervised) |
| Control | No intervention | –Continued usual care, habitual lifestyle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- any contra-indication for exercise therapy,
- glucose lowering medical therapy,
- active lifestyle with regular physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trainingAlso: 12 weeks of combined exercise training | Other | training |
Primary outcome
insulin sensitivity (insulin profile)
Time frame: change from baseline to 12 weeks
glucose and insulin concentration measurements in blood during oral glucose tolerance test
6 secondary outcomes
Exercise tolerance
Time frame: change from baseline to 12 weeks
HbA1c, blood lipids, BNP
Time frame: change from baseline to 12 weeks
Muscle strength
Time frame: change from baseline to 12 weeks
Body composition
Time frame: change from baseline to 12 weeks
cardiac function
Time frame: change from baseline to 12 weeks
Health-related quality of life
Time frame: change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An Stevens, dra. study chair
Hasselt University
Questions about this trial
What is this clinical trial studying?
A study testing training in people with Chronic Heart Failure, run by Hasselt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity (insulin profile) (time frame: change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.