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
ISRCTN | ISRCTN42524037 |
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DOI | https://doi.org/10.1186/ISRCTN42524037 |
Secondary identifying numbers | N/A |
- Submission date
- 04/07/2007
- Registration date
- 27/09/2007
- Last edited
- 08/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Frank Edelmann
Scientific
Scientific
Robert- Koch- Str. 40
Gottingen
37073
Germany
Phone | +49 (0)551 392658 |
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fedelmann@med.uni-goettingen.de |
Study information
Study design | Multicentre prospective randomized controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
Scientific title | 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 |
Study acronym | Ex-DHF-P |
Study objectives | Supervised combined endurance and strength exercise training for three months, two to three times/week improves the exercise capacity and quality of life in patients with diastolic heart failure compared to patients in a non-training control group. Please note that as of 01/11/2007 this trial has now been completed. The previous anticipated end date of this trial was 30/09/2008. |
Ethics approval(s) | Ethics approval received from the ethics committees of the Universities of Gottingen, Berlin, Munich (Germany) on the 14th September 2006 (ref: 38/9/06), following by amendment 1 on 22nd January 2007 and amendment 2 on 7th March 2007. |
Health condition(s) or problem(s) studied | Diastolic heart failure |
Intervention | Once randomised, patients will either participate in an combined endurance and strength exercise training two to three times/week for three months or perform their usual activities. After three months and the second visit all patients participate in the training for another three months. |
Intervention type | Other |
Primary outcome measure | Change in peak maximal oxygen uptake (VO2), measured at 3 months. |
Secondary outcome measures | 1. Change in quality of life 2. Change in early left ventricular filling-to-peak early diastolic myocardial velocity ratio (E/E' ratio) 3. Change in six-minute walking distance 4. Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) and other parameters of neurohumoral activation 5. Change in Heart Rate Variability (HRV) and Heart Rate Turbulence (HRT) 6. Change in blood levels of parameters of collagen turnover, metabolic syndrome and inflammation 7. Change in parameters of diastolic dysfunction: 7.1. Early-to-Atrial left ventricular filling ratio (E/A ratio) 7.2. Early left ventricular filling Deceleration Time (EDT) 7.3. Isovolumic Relaxation Time (IVRT) 7.4. Systolic-to-Diastolic pulmonary venous flow ratio (S/D ratio) 7.5. Pulmonary Venous peak Atrial contraction Reversed velocity (PVAR) 7.6. Colour M-Mode flow propagation Velocity (Vp) 7.7. Doppler echocardiography-derived index of myocardial performance (TEI-Index) 7.8. Left Ventricular mass (LV-mass) 7.9. Left Ventricular volume (LV-volume) 7.10. Left Atrial volume (LA-volume) 8. Severity of diastolic dysfunction (echocardiography) 9. Change in endothelial function, safety, compliance, cardiovascular morbidity and mortality Secondary outcomes are measured at 3 and 6 months |
Overall study start date | 01/10/2006 |
Completion date | 01/11/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 45 Years |
Sex | Both |
Target number of participants | 60 (40 versus 20) |
Total final enrolment | 64 |
Key inclusion criteria | 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% |
Key exclusion criteria | 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 |
Date of first enrolment | 01/10/2006 |
Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Robert- Koch- Str. 40
Gottingen
37073
Germany
37073
Germany
Sponsor information
Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
University/education
University/education
c/o Professor Dr Burkert Pieske
Robert- Koch- Str. 40
Gottingen
37073
Germany
pieske@med.uni-goettingen.de | |
Website | http://www.uni-goettingen.de/en/sh/1.html |
https://ror.org/01y9bpm73 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) - Health Research, Competence Network on Heart Failure
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 18/10/2011 | 24/05/2019 | Yes | No |
Results article | results | 01/05/2015 | 24/05/2019 | Yes | No |
Results article | results | 01/02/2017 | 24/05/2019 | Yes | No |
Results article | 29/04/2019 | 08/01/2024 | Yes | No |
Editorial Notes
08/01/2024: Publication reference added.
24/05/2019: Publication reference and total final enrolment added.