Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Aerobic-Resistance-Inspiratory; Other: Aerobic-Inspiratory; Other: Aerobic Training; Other: Aerobic-Resistance

• Registration Number: NCT03013270
• Lead Sponsor: Onassis Cardiac Surgery Centre

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

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Primary Completion: 2019-08
• Status Verified: 2020-04
• Study Completion: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARIS group	Aerobic-Resistance-Inspiratory	Aerobic-Resistance-Inspiratory
AT/IMT group	Aerobic-Inspiratory	Aerobic-Inspiratory
AT group	Aerobic Training	Aerobic Training
AT/RT group	Aerobic-Resistance	Aerobic-Resistance

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (3)

Asklepieion Voulas General Hospital; 🇬🇷 Voula, Attica, Greece

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Attica, Greece

Telecardiology Center, Institute of Cardiology; 🇵🇱 Warsaw, Poland