Heart FailureARISTOS-HFNCT03013270
Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure
A study testing Aerobic-Resistance-Inspiratory, Aerobic-Resistance and Aerobic-Inspiratory in people with Heart Failure, run by Onassis Cardiac Surgery Centre at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aerobic-Resistance-Inspiratory, Aerobic-Resistance and Aerobic-Inspiratory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2016to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure (from New York Heart Association (NYHA) functional class II to NYHA III)
- Left ventricular ejection fraction below or equal to 35%
Who cannot join
- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Greece2 sites
Onassis Cardiac Surgery Center
Athens, Attica, 176 74
Asklepieion Voulas General Hospital
Voula, Attica, 16673
About this study
Official title: 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.
Read the 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
- Being tested
- Aerobic-Resistance-Inspiratory, Aerobic-Resistance, Aerobic-Inspiratory, Aerobic Training
- Keywords
- Rehabilitation, Exercise, Training
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic-Resistance-InspiratoryOther
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-ResistanceOther
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-InspiratoryOther
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 TrainingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| ARIS group | Experimental | Aerobic-Resistance-Inspiratory Receives: Other: Aerobic-Resistance-Inspiratory |
| AT/RT group | Active comparator | Aerobic-Resistance Receives: Other: Aerobic-Resistance |
| AT/IMT group | Active comparator | Aerobic-Inspiratory Receives: Other: Aerobic-Inspiratory |
| AT group | Active comparator | Aerobic Training Receives: Other: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Before and after 12 weeks
Secondary outcomes (4)
change in walking distance using the 6-minute walking test (6MWT)
evaluation of submaximal exercise capacity
Measured: Before and after 12 weeks
change in quality of Life using the Minnesota Living with Heart Failure questionnaire
evaluation of life quality
Measured: Before and after 12 weeks
Preference Program Survey
Questionnaire to evaluate exercise program preference (most enjoyed program) using a scale from 1 (=Very Little) to 5 (=Excellent)
Measured: 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
evaluation of LVEF%
Measured: Before and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionAug 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onassis Cardiac Surgery Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Asklepieion Voulas General Hospital, National Institute of Cardiology, Warsaw, Poland
- Responsible party
- Principal investigator, Laoutaris Ioannis, Onassis Cardiac Surgery Centre
- Investigators
- Stamatis Adamopoulos, MD, Study chair, Onassis Cardiac Surgery Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013270
- Sponsor's protocol ID
- ARISTOS-HF
- Acronym
- ARISTOS-HF
- Status last verified
- Apr 2020
- First submitted
- 22 Dec 2016
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22658571Adamopoulos 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.
PubMed 24634346Beckers 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.
PubMed 18515805Smart 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.
PubMed 24294043Laoutaris 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.
PubMed 33624071
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure. The ARISTOS-HF Trial: a Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT03013270
- Acronym / sponsor ID
- ARISTOS-HF / ARISTOS-HF
- Conditions
- Heart Failure
- Keywords
- Rehabilitation, Exercise, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Onassis Cardiac Surgery CentreUniversity, hospital or other
- Collaborators
- Asklepieion Voulas General Hospital, National Institute of Cardiology, Warsaw, Poland
- Study start
- Sep 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARIS group | Experimental | Other: Aerobic-Resistance-InspiratoryAerobic-Resistance-Inspiratory |
| AT/RT group | Active comparator | Other: Aerobic-ResistanceAerobic-Resistance |
| AT/IMT group | Active comparator | Other: Aerobic-InspiratoryAerobic-Inspiratory |
| AT group | Active comparator | Other: Aerobic TrainingAerobic Training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic heart failure (from New York Heart Association (NYHA) functional class II to NYHA III)
- Left ventricular ejection fraction below or equal to 35%
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic-Resistance-InspiratoryPatients 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) | Other | ARIS group |
| Aerobic-ResistancePatients 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) | Other | AT/RT group |
| Aerobic-InspiratoryPatients 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) | Other | AT/IMT group |
| Aerobic TrainingPatients 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) | Other | AT group |
Primary outcome
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
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)
4 secondary outcomes
change in walking distance using the 6-minute walking test (6MWT)
Time frame: 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
Preference Program Survey
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Background: PubMed 22658571Laoutaris 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.
- Background: PubMed 24634346Adamopoulos 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.
- Background: PubMed 18515805Beckers 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.
- Background: PubMed 24294043Smart 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.
- Derived from this study: PubMed 33624071Laoutaris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stamatis Adamopoulos, MD study chair
Onassis Cardiac Surgery Centre
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic-Resistance-Inspiratory, Aerobic-Resistance and Aerobic-Inspiratory in people with Heart Failure, run by Onassis Cardiac Surgery Centre at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013270, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.