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
DOI	https://doi.org/10.1186/ISRCTN42524037
Protocol serial number	N/A
Sponsor	Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) - Health Research, Competence Network on Heart Failure

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

Robert- Koch- Str. 40
Gottingen
37073
Germany

Phone	+49 (0)551 392658
Email	fedelmann@med.uni-goettingen.de

Study information

Primary study design	Interventional
Study design	Multicentre prospective randomized controlled trial
Secondary study design	Randomised controlled trial
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(s)	Change in peak maximal oxygen uptake (VO2), measured at 3 months.
Key secondary outcome measure(s)	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
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	45 Years
Sex	All
Target sample size at registration	60
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.