Clinical trial NCT03013270: Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure
Official title: Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure. The ARISTOS-HF Trial: a Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Rehabilitation
Exercise
Training
Lead sponsor: Onassis Cardiac Surgery Centre
Sponsor class: OTHER
Collaborators: name: Asklepieion Voulas General Hospital
name: National Institute of Cardiology, Warsaw, Poland
First posted: 2017-01-06
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: 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)
timeFrame: Before and after 12 weeks
measure: 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
timeFrame: Before and after 12 weeks
Secondary outcomes:
measure: change in walking distance using the 6-minute walking test (6MWT)
timeFrame: Before and after 12 weeks
measure: change in quality of Life using the Minnesota Living with Heart Failure questionnaire
timeFrame: Before and after 12 weeks
measure: Preference Program Survey
timeFrame: After 12 weeks
measure: change in left ventricular ejection fraction, echocardiography (Ultrasound Vivid 7 or 6, General Electric Healthcare, Fairfield, CT, USA) with the biplane Simpson' s method
timeFrame: Before and after 12 weeks
Other outcomes:
measure: Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing
timeFrame: Before and after 12 weeks
measure: Change in maximal inspiratory pressure (PImax in cmH2O) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).
timeFrame: Before and after 12 weeks
measure: 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).
timeFrame: Before and after 12 weeks
measure: Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM)
timeFrame: Before and after 12 weeks
measure: Change in skeletal muscle endurance will be evaluated using the quadriceps muscle endurance with the product: 50%1Repetition Maximum x max number of reps
timeFrame: Before and after 12 weeks
measure: Morbidity Records
timeFrame: 6 months and 12 months after completion of Exercise Programs
Locations:
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
state: Attica
city: Voula
country: Greece
facility: Asklepieion Voulas General Hospital
state: Attica
city: Warsaw
country: Poland
facility: Telecardiology Center, Institute of Cardiology
Study officials:
affiliation: Onassis Cardiac Surgery Center
name: Stamatis Adamopoulos, MD
role: STUDY_CHAIR
References:
citation: Laoutaris ID, Adamopoulos S, Manginas A, Panagiotakos DB, Kallistratos MS, Doulaptsis C, Kouloubinis A, Voudris V, Pavlides G, Cokkinos DV, Dritsas A. Benefits of combined aerobic/resistance/inspiratory training in patients with chronic heart failure. A complete exercise model? A prospective randomised study. Int J Cardiol. 2013 Sep 1;167(5):1967-72. doi: 10.1016/j.ijcard.2012.05.019. Epub 2012 May 31.
citation: Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.
citation: Beckers PJ, Denollet J, Possemiers NM, Wuyts FL, Vrints CJ, Conraads VM. Combined endurance-resistance training vs. endurance training in patients with chronic heart failure: a prospective randomized study. Eur Heart J. 2008 Aug;29(15):1858-66. doi: 10.1093/eurheartj/ehn222. Epub 2008 May 30.
citation: Smart NA. How do cardiorespiratory fitness improvements vary with physical training modality in heart failure patients? A quantitative guide. Exp Clin Cardiol. 2013 Winter;18(1):e21-5.
citation: Laoutaris ID, Piotrowicz E, Kallistratos MS, Dritsas A, Dimaki N, Miliopoulos D, Andriopoulou M, Manolis AJ, Volterrani M, Piepoli MF, Coats AJS, Adamopoulos S; ARISTOS-HF trial (Aerobic, Resistance, InSpiratory Training OutcomeS in Heart Failure) Investigators. Combined aerobic/resistance/inspiratory muscle training as the 'optimum' exercise programme for patients with chronic heart failure: ARISTOS-HF randomized clinical trial. Eur J Prev Cardiol. 2021 Dec 29;28(15):1626-1635. doi: 10.1093/eurjpc/zwaa091.