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
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

Robert- Koch- Str. 40
Gottingen
37073
Germany

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

Study information

Study designMulticentre prospective randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleExercise 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 acronymEx-DHF-P
Study objectivesSupervised 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) studiedDiastolic heart failure
InterventionOnce 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 typeOther
Primary outcome measureChange in peak maximal oxygen uptake (VO2), measured at 3 months.
Secondary outcome measures1. 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 date01/10/2006
Completion date01/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit45 Years
SexBoth
Target number of participants60 (40 versus 20)
Total final enrolment64
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2006
Date of final enrolment01/11/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Robert- Koch- Str. 40
Gottingen
37073
Germany

Sponsor information

Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
University/education

c/o Professor Dr Burkert Pieske
Robert- Koch- Str. 40
Gottingen
37073
Germany

Email pieske@med.uni-goettingen.de
Website http://www.uni-goettingen.de/en/sh/1.html
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.