Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure (ARISTOS-HF)

May 1, 2020 updated by: Laoutaris Ioannis, Onassis Cardiac Surgery Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 176 74
        • Onassis Cardiac Surgery Center
      • Voula, Attica, Greece, 16673
        • Asklepieion Voulas General Hospital
  • Poland
      • Warsaw, Poland, 04-828
        • Telecardiology Center, Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARIS group
Aerobic-Resistance-Inspiratory
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)
Active Comparator: AT/RT group
Aerobic-Resistance
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)
Active Comparator: AT/IMT group
Aerobic-Inspiratory
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)
Active Comparator: AT group
Aerobic Training
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Before and after 12 weeks
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
Time Frame: Before and after 12 weeks
evaluation of cardiac structure (LVEDD, LVESD in mm)
Before and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in walking distance using the 6-minute walking test (6MWT)
Time Frame: Before and after 12 weeks
evaluation of submaximal exercise capacity
Before and after 12 weeks
change in quality of Life using the Minnesota Living with Heart Failure questionnaire
Time Frame: Before and after 12 weeks
evaluation of life quality
Before and after 12 weeks
Preference Program Survey
Time Frame: After 12 weeks
Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent)
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
Time Frame: Before and after 12 weeks
evaluation of LVEF%
Before and after 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dyspnoea using the Borg scale (0-10) at the end of exercise testing
Time Frame: Before and after 12 weeks
evaluation of dyspnea
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).
Time Frame: Before and after 12 weeks
evaluation of inspiratory muscle strength
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).
Time Frame: Before and after 12 weeks
evaluation of an inspiratory muscle endurance index
Before and after 12 weeks
Change in skeletal muscle strength will be evaluated using the quadriceps 1 repetition maximum (1RM)
Time Frame: Before and after 12 weeks
evaluation of skeletal muscle strength
Before and after 12 weeks
Change in skeletal muscle endurance will be evaluated using the quadriceps muscle endurance with the product: 50%1Repetition Maximum x max number of reps
Time Frame: Before and after 12 weeks
evaluation of skeletal muscle endurance
Before and after 12 weeks
Morbidity Records
Time Frame: 6 months and 12 months after completion of Exercise Programs
Evaluate Morbidity
6 months and 12 months after completion of Exercise Programs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onassis Cardiac Surgery Centre

Collaborators

Institute of Cardiology, Warsaw, Poland
Asklepieion Voulas General Hospital

Investigators

  • Study Chair: Stamatis Adamopoulos, MD, Onassis Cardiac Surgery Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARISTOS-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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