Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176319
Status:
COMPLETED
Last Update Posted:
2009-07-15
First Post:
2005-09-09
Brief Title:
Leipzig Exercise Intervention in Chronic Heart Failure and Aging
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
Age-related Functional and Molecular Effects of Short-term Aerobic Endurance Training in Patients With Stable Chronic Heart Failure and Age-matched Healthy Controls
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEICA
Brief Summary:
In both ageing and heart failure progressive exercise intolerance is observed The Leipzig Exercise Intervention in Chronic heart failure and Aging LEICA study aims to investigate how aerobic short-term training interventions affect exercise capacity left ventricular systolic and diastolic function biomarkers of heart failure skeletal muscle metabolism and endothelial function in chronis heart failure patients CHF-patients and healthy subjects HS in two different age strata Above 65 years and below 55 years
Aim of the trial is therefore to compare the effects of aerobic exercise training in young and old healthy subjects as well as in young and old heart failure patients To our knowledge this study is the first to prospectively investigate age differences of training responses in both CHF patients and age-matched healthy controls
Because of the extensive clinical and molecular assessment the results of this trial will be made public in predefined substudies
LEICA-Echo
LEICA-Biomarkers
LEICA-Endothelium
LEICA-Cardiopulmonary Exercise Function
LEICA-Muscle
Aim of the trial is therefore to compare the effects of aerobic exercise training in young and old healthy subjects as well as in young and old heart failure patients To our knowledge this study is the first to prospectively investigate age differences of training responses in both CHF patients and age-matched healthy controls
Because of the extensive clinical and molecular assessment the results of this trial will be made public in predefined substudies
LEICA-Echo
LEICA-Biomarkers
LEICA-Endothelium
LEICA-Cardiopulmonary Exercise Function
LEICA-Muscle
Detailed Description:
A total of 60 healthy subjects and 60 heart failure patients in each group 30 55 years 30 65 years are prospectively randomized to either 4 weeks of aerobic ergometer training or control group
Before and after the intervention period maximal exercise tolerance is determined by ergospirometry endothelial function is measured by high-resolution A-mode ultrasound left ventricular function by echocardiography including tissue Doppler imaging and thigh muscle mass is assessed by CT Skeletal muscle biopsies are obtained at both time-points and are analysed for inflammatory cytokines and markers of catabolismanabolism
Before and after the intervention period maximal exercise tolerance is determined by ergospirometry endothelial function is measured by high-resolution A-mode ultrasound left ventricular function by echocardiography including tissue Doppler imaging and thigh muscle mass is assessed by CT Skeletal muscle biopsies are obtained at both time-points and are analysed for inflammatory cytokines and markers of catabolismanabolism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GI 5351-1 | None | None | None |