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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03013270 |
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Date of registration:
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22/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure
ARISTOS-HF |
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Scientific title:
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Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure. The ARISTOS-HF Trial: a Prospective Randomized Multicenter Trial |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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88 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03013270 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Poland
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Contacts
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Name:
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Stamatis Adamopoulos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Onassis Cardiac Surgery Center |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Other: Aerobic-Resistance
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Other: Aerobic-Inspiratory
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Other: Aerobic Training
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Other: Aerobic-Resistance-Inspiratory
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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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]
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Preference Program Survey
[Time Frame: After 12 weeks]
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change in walking distance using the 6-minute walking test (6MWT)
[Time Frame: Before and after 12 weeks]
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change in quality of Life using the Minnesota Living with Heart Failure questionnaire
[Time Frame: Before and after 12 weeks]
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Secondary ID(s)
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ARISTOS-HF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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