An interventional study of Aerobic-Resistance-Inspiratory and Aerobic-Resistance in Heart Failure, sponsored by Onassis Cardiac Surgery Centre. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Onassis Cardiac Surgery Centre · Not applicable, Interventional, and Treatment
This study investigates the effects of aerobic, resistance, inspiratory training modalities outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming for the 'optimum' (greek, αριστος=aristos) training program for HF patients.
Heart failure is a clinical syndrome characterized by symptoms of dyspnea, exercise intolerance and decreased quality of life. A weakness in both inspiratory and peripheral muscles is also reported. Aerobic training (AT) improves the functional status of HF patients (level of evidence IA). Additional benefits of inspiratory muscle training (IMT) and/or resistance training (RT) when combined with aerobic training (AT) in HF symptoms have also been found.
Four exercise groups will be studied in order to identify the optimum exercise program I. Aerobic-Resistance-Inspiratory training (ARIS) group II. Aerobic Training-Resistance Training (AT/RT) group III. Aerobic training-Inspiratory Muscle Training (AT/IMT) group IV. Aerobic Training (AT) group
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 88 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Onassis Cardiac Surgery Centre is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Aerobic-Resistance-Inspiratory
Other: Aerobic-Resistance-Inspiratory
Aerobic-Resistance
Other: Aerobic-Resistance
Aerobic-Inspiratory
Other: Aerobic-Inspiratory
Aerobic Training
Other: Aerobic Training
Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1 Repetition Maximum (1RM) for quads training and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets) for 10 min, combined also with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 20 min (Aerobic (30min) + Resistance (10min) + Inspiratory (20min) = 60 min)
Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1RM for quads training, pectoralis m, serratus anterior m, and latissimus dorsi m and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets). (Aerobic (30min) + Resistance (30min) = 60 min)
Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 30min (Aerobic (30min) + Inspiratory (30min) = 60 min)
Patients will be submitted to a 12 week, 3 times/week continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with callisthenics progressing to treadmill or bike (at the same intensity) for 30 min (Aerobic training = 60 min)
change in peak oxygen consumption (peakVO2, in ml/kg/min) using cardiopulmonary exercise testing (Medgraphics CPX/MAX, Medical Graphics Corp.,St. Paul, MN, USA, ZAN 600, ZAN Messgera¨te GmbH, Germany)
evaluation of maximal exercise capacity
Time frame: Before and after 12 weeks
change in left ventricular dimension (mm) using resting 2-dimensional echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the Teichholz method
evaluation of cardiac structure (LVEDD, LVESD in mm)
Time frame: Before and after 12 weeks
change in walking distance using the 6-minute walking test (6MWT)
evaluation of submaximal exercise capacity
Time frame: Before and after 12 weeks
change in quality of Life using the Minnesota Living with Heart Failure questionnaire
evaluation of life quality
Time frame: Before and after 12 weeks
Preference Program Survey
Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent)
Time frame: After 12 weeks
change in left ventricular ejection fraction, echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the biplane Simpson' s method
evaluation of LVEF%
Time frame: Before and after 12 weeks
Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing
evaluation of dyspnea
Time frame: Before and after 12 weeks
Change in maximal inspiratory pressure (PImax in cmH2O) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).
evaluation of inspiratory muscle strength
Time frame: Before and after 12 weeks
Change in inspiratory work capacity (sustained maximal inspiratory pressure (SPImax in cmH2O/s) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).
evaluation of an inspiratory muscle endurance index
Time frame: Before and after 12 weeks
Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM)
evaluation of skeletal muscle strength
Time frame: Before and after 12 weeks
Change in skeletal muscle endurance will be evaluated using the quadriceps muscle endurance with the product: 50%1Repetition Maximum x max number of reps
evaluation of skeletal muscle endurance
Time frame: Before and after 12 weeks
Morbidity Records
Evaluate Morbidity
Time frame: 6 months and 12 months after completion of Exercise Programs
Plan to share: No
The record gives a start of Sep 2016, a primary completion of Aug 2019 and a completion of May 2020. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Onassis Cardiac Surgery Centre