Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure (ARISTOS-HF)

Onassis Cardiac Surgery Centre

Status: Completed

Conditions: Heart Failure

Treatments: Other: Aerobic-Inspiratory; Other: Aerobic Training; Other: Aerobic-Resistance; Other: Aerobic-Resistance-Inspiratory

Study type: Interventional

Funder types: Other

Identifiers

NCT03013270

ARISTOS-HF

Details and patient eligibility

About

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.

Full 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

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 4 patient groups

ARIS group

Experimental group

Description:

Aerobic-Resistance-Inspiratory

Treatment:

Other: Aerobic-Resistance-Inspiratory

AT/RT group

Active Comparator group

Description:

Aerobic-Resistance

Treatment:

Other: Aerobic-Resistance

AT/IMT group

Active Comparator group

Description:

Aerobic-Inspiratory

Treatment:

Other: Aerobic-Inspiratory

AT group

Active Comparator group

Description:

Aerobic Training

Treatment:

Other: Aerobic Training