Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure

NCT ID: NCT03013270

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-05-31

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ARIS group

Aerobic-Resistance-Inspiratory

Group Type: EXPERIMENTAL

Aerobic-Resistance-Inspiratory

Intervention Type: OTHER

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)

AT/RT group

Aerobic-Resistance

Group Type: ACTIVE_COMPARATOR

Aerobic-Resistance

Intervention Type: OTHER

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)

AT/IMT group

Aerobic-Inspiratory

Group Type: ACTIVE_COMPARATOR

Aerobic-Inspiratory

Intervention Type: OTHER

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)

AT group

Aerobic Training

Group Type: ACTIVE_COMPARATOR

Aerobic Training

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asklepieion Voulas General Hospital

OTHER_GOV

Sponsor Role: collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role: collaborator

Onassis Cardiac Surgery Centre

OTHER

Sponsor Role: lead

Responsible Party

Laoutaris Ioannis

PhD FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stamatis Adamopoulos, MD

Role: STUDY_CHAIR

Onassis Cardiac Surgery Center

Locations

Onassis Cardiac Surgery Center

Athens, Attica, Greece

Asklepieion Voulas General Hospital

Voula, Attica, Greece

Telecardiology Center, Institute of Cardiology

Warsaw, , Poland

Countries

Greece; Poland

References

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.

Reference Type: BACKGROUND

PMID: 22658571 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24634346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18515805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24294043 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33624071 (View on PubMed)

Other Identifiers

ARISTOS-HF

Identifier Type: -

Identifier Source: org_study_id