Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure

Heart Failure Clinical Trial

— ARISTOS-HF  

Official title:

Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure. The ARISTOS-HF Trial: a Prospective Randomized Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013270
• Other study ID #: ARISTOS-HF
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: May 2020

Study information

• Verified date: April 2020
• Source: Onassis Cardiac Surgery Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Aerobic-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)
• Aerobic-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)
• Aerobic-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)
• 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 callisthenics progressing to treadmill or bike (at the same intensity) for 30 min (Aerobic training = 60 min)

Locations

Country	Name	City	State
Greece	Onassis Cardiac Surgery Center	Athens	Attica
Greece	Asklepieion Voulas General Hospital	Voula	Attica
Poland	Telecardiology Center, Institute of Cardiology	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
Onassis Cardiac Surgery Centre	Asklepieion Voulas General Hospital, Institute of Cardiology, Warsaw, Poland

Countries where clinical trial is conducted

Greece,  Poland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing	evaluation of dyspnea	Before and after 12 weeks
Other	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	Before and after 12 weeks
Other	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	Before and after 12 weeks
Other	Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM)	evaluation of skeletal muscle strength	Before and after 12 weeks
Other	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	Before and after 12 weeks
Other	Morbidity Records	Evaluate Morbidity	6 months and 12 months after completion of Exercise Programs
Primary	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	Before and after 12 weeks
Primary	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)	Before and after 12 weeks
Secondary	change in walking distance using the 6-minute walking test (6MWT)	evaluation of submaximal exercise capacity	Before and after 12 weeks
Secondary	change in quality of Life using the Minnesota Living with Heart Failure questionnaire	evaluation of life quality	Before and after 12 weeks
Secondary	Preference Program Survey	Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent)	After 12 weeks
Secondary	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%	Before and after 12 weeks