Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure

NCT03013270 | Completed

• 1 other identifier: ARISTOS-HF
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 3

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.

Conditions

Heart Failure

Keywords

Rehabilitation; Exercise; Training

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• change in walking distance using the 6-minute walking test (6MWT)

  Before and after 12 weeks

• change in quality of Life using the Minnesota Living with Heart Failure questionnaire

  Before and after 12 weeks

• Preference Program Survey

  After 12 weeks

• 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

Other Outcomes (6)

• Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing

  Before and after 12 weeks

• Change in maximal inspiratory pressure (PImax in cmH2O) using an electronic pressure manometer with computer software (TRAINAIR®, Project Electronics Ltd, London, UK).

  Before and after 12 weeks

• 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).

  Before and after 12 weeks

Study Arms (4)

ARIS group

EXPERIMENTAL

Aerobic-Resistance-Inspiratory

Other: Aerobic-Resistance-Inspiratory

AT/RT group

ACTIVE COMPARATOR

Aerobic-Resistance

Other: Aerobic-Resistance

AT/IMT group

ACTIVE COMPARATOR

Aerobic-Inspiratory

Other: Aerobic-Inspiratory

AT group

ACTIVE COMPARATOR

Aerobic Training

Other: Aerobic Training

Interventions

Aerobic-Resistance-Inspiratory 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)

ARIS group

Aerobic-Resistance 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/RT group

Aerobic-Inspiratory 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/IMT group

Aerobic Training 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)

AT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure (from New York Heart Association (NYHA) functional class II to NYHA III)
• Left ventricular ejection fraction below or equal to 35%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Onassis Cardiac Surgery Centre: lead
• Asklepieion Voulas General Hospital: collaborator
• National Institute of Cardiology, Warsaw, Poland: collaborator

Study Sites (3)

Onassis Cardiac Surgery Center

Athens, Attica, 176 74, Greece

Location

Asklepieion Voulas General Hospital

Voula, Attica, 16673, Greece

Location

Telecardiology Center, Institute of Cardiology

Warsaw, 04-828, Poland

Location

Related Publications (5)

• 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.

  PMID: 22658571 BACKGROUND

• 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.

  PMID: 24634346 BACKGROUND

• 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.

  PMID: 18515805 BACKGROUND

• 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.

  PMID: 24294043 BACKGROUND

• 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.

  PMID: 33624071 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Stamatis Adamopoulos, MD

  Onassis Cardiac Surgery Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD FESC

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 6, 2017
• Study Start: September 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2); PL (1)