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Completed

NCT Number: NCT03013270

Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Motor Activity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onassis Cardiac Surgery Center, Athens, Attica, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

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)

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)

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)

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

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

    Time frame: Before and after 12 weeks

    evaluation of submaximal exercise capacity

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

    Time frame: Before and after 12 weeks

    evaluation of life quality

  3. 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)

  4. 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%

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Morbidity Records

    Time frame: 6 months and 12 months after completion of Exercise Programs

    Evaluate Morbidity

Sponsors and collaborators

Lead sponsor

Onassis Cardiac Surgery Centre

Other

Collaborators

  • Asklepieion Voulas General Hospital
  • National Institute of Cardiology, Warsaw, Poland

Registry information

Official study title

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

Acronym: ARISTOS-HF

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 6, 2017
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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