Heart Failure
Conditions
Keywords
Rehabilitation, Exercise, Training
Brief summary
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.
Detailed description
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
Interventions
OTHERAerobic-Resistance-Inspiratory
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)
OTHERAerobic-Resistance
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)
OTHERAerobic-Inspiratory
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)
OTHERAerobic 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 callisthenics progressing to treadmill or bike (at the same intensity) for 30 min (Aerobic training = 60 min)
Sponsors
Asklepieion Voulas General Hospital
National Institute of Cardiology, Warsaw, Poland
Onassis Cardiac Surgery Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic heart failure (from New York Heart Association (NYHA) functional class II to NYHA III) * Left ventricular ejection fraction below or equal to 35%
Exclusion criteria
* Uncontrolled arrhythmia * Pulmonary oedema or pulmonary congestion in the last 30 days * Cognitive, neurological or orthopaedic limitations * Respiratory infection during 30 days before the start of the study * Pulmonary limitations (e.g COPD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Before and after 12 weeks | evaluation of maximal exercise capacity |
| 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 | Before and after 12 weeks | evaluation of cardiac structure (LVEDD, LVESD in mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in left ventricular ejection fraction, echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the biplane Simpson' s method | Before and after 12 weeks | evaluation of LVEF% |
| change in walking distance using the 6-minute walking test (6MWT) | Before and after 12 weeks | evaluation of submaximal exercise capacity |
| change in quality of Life using the Minnesota Living with Heart Failure questionnaire | Before and after 12 weeks | evaluation of life quality |
| Preference Program Survey | After 12 weeks | Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in skeletal muscle endurance will be evaluated using the quadriceps muscle endurance with the product: 50%1Repetition Maximum x max number of reps | Before and after 12 weeks | evaluation of skeletal muscle endurance |
| Morbidity Records | 6 months and 12 months after completion of Exercise Programs | Evaluate Morbidity |
| Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing | Before and after 12 weeks | evaluation of dyspnea |
| Change in maximal inspiratory pressure (PImax in cmH2O) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK). | Before and after 12 weeks | evaluation of inspiratory muscle strength |
| 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). | Before and after 12 weeks | evaluation of an inspiratory muscle endurance index |
| Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM) | Before and after 12 weeks | evaluation of skeletal muscle strength |
Countries
Greece, Poland
Outcome results
None listed