Exercise Training Effects in Patients With Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Exercise training
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring interval training, strength training, exercise capacity, chronic heart failure, Cardiac rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Stable systolic heart failure
- NYHA functional class ≤ III
- Optimal medical treatment
Exclusion Criteria:
- Contraindications for a maximal cardiopulmonary exercise testing (CPET) according to the American Thoracic Society/American College of Chest Physicians Statement
- Moderate to severe COPD
Sites / Locations
- Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, First Critical Care Unit, School of Medicine, National & Kapodistrian University of Athens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Combined interval and strength training
Aerobic interval training
Arm Description
CHF Pts randomly designed at the combined interval and strength training group
CHF Patients that randomly designed to participate at the interval training group
Outcomes
Primary Outcome Measures
Aerobic exercise capacity
Secondary Outcome Measures
Endothelial function, oxygen kinetics, ventilatory drive
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01071629
Brief Title
Exercise Training Effects in Patients With Heart Failure
Official Title
Aerobic Interval Training Versus Combined Aerobic Interval Training and Strength Training Effects in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic and peripheral vascular and muscle abnormalities including autonomic imbalance, neuro-hormonal over-activation and decreased oxidative status.
In patients suffering from CHF, exercise confers several beneficial effects on the cardiovascular and peripheral systems, mainly by continuous aerobic training. However, interval aerobic training has also been validated as an alternate form of training that increases the exercise capacity of patients who are in CHF.
Recent studies have suggested that resistance training alone or as a complementary program besides the traditionally aerobic continuous training might exert favorable effects. However, little it is known about the combined effects of interval and strength training in CHF patients.
Aim of this prospective randomized controlled study was to investigate the effects of combined interval and strength training comparing to interval training alone in CHF patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
interval training, strength training, exercise capacity, chronic heart failure, Cardiac rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined interval and strength training
Arm Type
Active Comparator
Arm Description
CHF Pts randomly designed at the combined interval and strength training group
Arm Title
Aerobic interval training
Arm Type
Active Comparator
Arm Description
CHF Patients that randomly designed to participate at the interval training group
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Interval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 40 min in the interval training group
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Interval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 20 min and Strength training of the quadriceps, hamstrings, muscles of the shoulder and biceps brachialis for 20 min 3 times per week for 36 sessions
Primary Outcome Measure Information:
Title
Aerobic exercise capacity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Endothelial function, oxygen kinetics, ventilatory drive
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable systolic heart failure
NYHA functional class ≤ III
Optimal medical treatment
Exclusion Criteria:
Contraindications for a maximal cardiopulmonary exercise testing (CPET) according to the American Thoracic Society/American College of Chest Physicians Statement
Moderate to severe COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serafim Nanas, MD
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, First Critical Care Unit, School of Medicine, National & Kapodistrian University of Athens
City
Athens
ZIP/Postal Code
10676
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
21703531
Citation
Anagnostakou V, Chatzimichail K, Dimopoulos S, Karatzanos E, Papazachou O, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval cycle training with or without strength training on vascular reactivity in heart failure patients. J Card Fail. 2011 Jul;17(7):585-91. doi: 10.1016/j.cardfail.2011.02.009. Epub 2011 Apr 22.
Results Reference
result
PubMed Identifier
20663654
Citation
Tasoulis A, Papazachou O, Dimopoulos S, Gerovasili V, Karatzanos E, Kyprianou T, Drakos S, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval exercise training on respiratory drive in patients with chronic heart failure. Respir Med. 2010 Oct;104(10):1557-65. doi: 10.1016/j.rmed.2010.03.009.
Results Reference
result
PubMed Identifier
20562711
Citation
Bouchla A, Karatzanos E, Dimopoulos S, Tasoulis A, Agapitou V, Diakos N, Tseliou E, Terrovitis J, Nanas S. The addition of strength training to aerobic interval training: effects on muscle strength and body composition in CHF patients. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):47-51. doi: 10.1097/HCR.0b013e3181e174d7. Erratum In: J Cardiopulm Rehabil Prev. 2011 Nov;31(6):E1.
Results Reference
result
PubMed Identifier
19770806
Citation
Gerovasili V, Drakos S, Kravari M, Malliaras K, Karatzanos E, Dimopoulos S, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Physical exercise improves the peripheral microcirculation of patients with chronic heart failure. J Cardiopulm Rehabil Prev. 2009 Nov-Dec;29(6):385-91. doi: 10.1097/HCR.0b013e3181b4ca4e.
Results Reference
result
Citation
M.Kravari, I. Vasileiadis, V. Gerovasili, E. Karatzanos, A. Tasoulis, K. Kalligras, S. Drakos, S. Dimopoulos, M. Anastasiou-Nana, S. Nanas. Effects of a 3-month rehabilitation program on muscle oxygenation in congestive heart failure patients as assessed by NIRS. International Journal of Industrial Ergonomics 40(2): 212-217, 2010
Results Reference
result
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Exercise Training Effects in Patients With Heart Failure
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