- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01071629
Exercise Training Effects in Patients With Heart Failure
Aerobic Interval Training Versus Combined Aerobic Interval Training and Strength Training Effects in Patients With Heart Failure
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Athens, Greece, 10676
- Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, First Critical Care Unit, School of Medicine, National & Kapodistrian University of Athens
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Combined interval and strength training
CHF Pts randomly designed at the combined interval and strength training group
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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
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
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Active Comparator: Aerobic interval training
CHF Patients that randomly designed to participate at the interval training group
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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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Aerobic exercise capacity
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial function, oxygen kinetics, ventilatory drive
Time Frame: 3 months
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serafim Nanas, MD, University of Athens
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOA-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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