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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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23 October 2023 |
Main ID: |
NCT03538119 |
Date of registration:
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15/05/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Comparison Between HIIT and MICT on the Phase III of Cardiac Rehabilitation
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Scientific title:
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Phase III Cardiac Rehabilitation in Coronary Patients: High-intensity Interval Training or Moderate-intensity Continuous Training? |
Date of first enrolment:
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December 19, 2018 |
Target sample size:
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69 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03538119 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Catarina Gonçalves |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Évora |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- low-moderate risk for physical exercise, with the following pathologies / conditions:
- stable coronary disease;
- after acute myocardial infarction;
- after coronary angioplasty;
- after cardiac surgery (coronary revascularization or valve surgery);
- stable chronic heart failure in class I-II of the New York Heart Association;
- acceptance of the informed consent assumptions of CR programs;
- must not have participated in physical exercise programs in the 3 months preceding the
referral;
- should not have more than one hour of vigorous physical activity per week according to
the International Physical Activity Questionnaire.
Exclusion Criteria:
- presenting symptoms of heart failure of class III and IV according to the New York
Heart Association (or documented signs and symptoms of chronic heart failure with
ejection fraction >45%);
- uncontrolled arrhythmias;
- severe chronic obstructive pulmonary disease;
- uncontrolled hypertension;
- symptomatic peripheral arterial disease; unstable angina;
- uncontrolled diabetes;
- inability to perform a maximum VO2 test;
- locomotion exclusively dependent on mechanical means.
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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Patients With Coronary Artery Disease
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Intervention(s)
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Other: Moderate Intensity Continuous Training Program
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Other: High Intensity Interval Training Program
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Primary Outcome(s)
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Change from Baseline between and within groups comparison in Body Composition
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Aerobic Capacity
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Lipid Profile
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Blood Pressure Profile
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Muscle Strength
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Physical Activity Levels
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Secondary Outcome(s)
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Change from Baseline between and within groups comparison in Bone Composition
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Health-related Quality of Life
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Sleep Quality
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Change from Baseline between and within groups comparison in Anxiety and Depression
[Time Frame: 0 weeks, 6 weeks, 6 months and 12 months]
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Secondary ID(s)
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CR_UEvora
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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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