Exercise training in Diastolic Heart Failure - Pilot study: a prospective, randomised, controlled study to determine the effects of physical training on exercise capacity and quality of life
- Conditions
- Diastolic heart failureCirculatory SystemHeart disease
- Registration Number
- ISRCTN42524037
- Lead Sponsor
- Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
- Brief Summary
2011 Results article in https://www.ncbi.nlm.nih.gov/pubmed/21996391 results (added 24/05/2019) 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24627449 results (added 24/05/2019) 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28217313 results (added 24/05/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31035733/ (added 08/01/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
1. At least one of the following risk factors for the development of a diastolic dysfunction:
1.1. Diabetes
1.2. Hypertension
1.3. Smoking
1.4. Hyperlipidaemia
1.5. Overweight
2. Aged greater than or equal to 45 years
3. Written informed consent
4. New York Heart Association (NYHA) II or III
5. Diastolic dysfunction greater than or equal to grade one (echocardiographically determined)
6. Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50%
1. Diseases limiting the validity of consent (psychiatric diseases, dementia etc.,)
2. Change in medication within the last two weeks
3. Limited exercise capacity due to musculo-skeletal diseases or pulmonary disease
4. Myocardial Infarction (MI) or bypass surgery in the patient's history or clinically significant Coronary Artery Disease (CAD) (angina or known untreated stenosis of more than 50%) or peripheral arterial obstructive disease greater than or equal to IIa
5. Pregnant or nursing women and women before menopause without sufficient contraception
6. Participaton in another study currently or within the last 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method