|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
23 March 2015 |
|
Main ID: |
NCT02387411 |
|
Date of registration:
|
19/02/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
High-intensity Interval Versus Combined Exercise Training in CHF
|
|
Scientific title:
|
High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure |
|
Date of first enrolment:
|
May 2010 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT02387411 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
Serafim Nanas, MD, Prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- stable heart failure
- ejection fraction <=45%
- optimal medical treatment
- NYHA class <=III
Exclusion Criteria:
- contraindications for maximal cardiopulmonary exercise testing (CPET)
- moderate to severe COPD
- inability to follow exercise programs due to orthopaedic problems
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure
|
|
Intervention(s)
|
|
Other: High-intensity interval exercise training
|
|
Other: Combined exercise training
|
|
Primary Outcome(s)
|
|
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
quality of life (assessed by MLWHF questionnaire)
[Time Frame: 3 months]
|
|
quadriceps cross sectional area (assessed by CT)
[Time Frame: 3 months]
|
|
strength exercise capacity (assessed by 1-repetition maximum test)
[Time Frame: 3 months]
|
|
quadriceps local adaptations (assessed by muscle biopsies)
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
not applied
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|