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Comparison Between HIIT and Continuous Training on the Phase III of Cardiac Rehabilitation

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ClinicalTrials.gov Identifier: NCT03538119
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Catarina Joaquim Gonçalves, University of Évora

Brief Summary:

The increase in the prevalence of cardiovascular diseases (CD), directly associated with the aging of the population, is a concern for public health in Portugal. Given the high prevalence of risk factors and the increasing number of cases of CD throughout Alentejo, where there is no cardiac rehabilitation (CR) coverage, there is an urgent need for the implementation of a CR program.

CR has evolved over the past decades to multidisciplinary approaches focused on education, individualized training, modification of risk factors, and overall well-being of cardiac patients. Studies suggest that high intensity interval training (HIIT) allows greater patient benefits compared to moderate continuous training (MCT), reversal of DC and increased aerobic capacity in CR patients. This study intends to compare HIIT and MTC interventions investigating direct and indirect associations between informally performed physical activity (AF), sedentary behavior, cardiovascular fitness and quality of life (QoL) among patients enrolled in RC programs in phase III.


Condition or disease Intervention/treatment Phase
Cardiac Patients Other: High intensity interval training program Other: Moderate continuous training program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between High Intensity Interval Training and Traditional Continuous Training on the Phase III of Cardiac Rehabilitation
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIIT program
Three sessions of exercises will be performed weekly with duration of 30 min to 60 min, divided into heating, aerobic exercise and recovery.
Other: High intensity interval training program

The HIIT protocol will consist of four four-minute high-intensity intervals, stimulating 85-95% peak-FC followed by active recovery at 70% peak-FC for a total of 20 minutes. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of maximal HR) and a 3 to 5 minute calm return period was performed at 50% of the HR peak.

The supervised sessions will take place on a cycle ergometer and treadmill, 3 times a week for 6 consecutive weeks. If a session is lost, it will be recovered that week or the following week. Each session will be limited to three participants.

Other Name: HIIT

Experimental: Moderate continuous training program
Three sessions of exercises will be performed weekly with duration of 30 min to 60 min, divided into heating, aerobic exercise and recovery.
Other: Moderate continuous training program

The MCT protocol consists of continuously exerting moderate intensity, causing a peak FC-70-75% for 27.5 minutes to equal the energy expenditure of the HIIT protocol. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of maximal HR) and a 3 to 5 minute calm return period was performed at 50% of the HR peak.

The supervised sessions will take place on a cycle ergometer and treadmill, 3 times a week for 6 consecutive weeks. If a session is lost, it will be recovered that week or the following week.

Other Name: MCT

No Intervention: Control Group
Usual care. The patients will receive nutritional counseling as well as physical activity.



Primary Outcome Measures :
  1. Change from Baseline between and within groups comparison, in Cardiac Profile [ Time Frame: 0, 6, 12 weeks ]
    Systolic and diastolic blood pressure, in mmHg, to assess blood profile

  2. Change from Baseline between and within groups comparison, in Cardiac Profile [ Time Frame: 0, 6, 12 weeks ]
    Basal Heart Rate, in heart beats per minute, to assess blood profile.

  3. Change from Baseline between and within groups comparison, in Lipid Profile [ Time Frame: 0, 6, 12 weeks ]
    Evaluated with blood tests to assess fasting triglyceride levels (mg/dL), total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), insulin (mg/dL) and glucose (mg/dL)

  4. Change from Baseline between and within groups comparison, in Bone Composition [ Time Frame: 0, 6, 12 weeks ]
    Evaluated with the Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)

  5. Change from Baseline between and within groups comparison, in Body Densitometry [ Time Frame: 0, 6, 12 weeks ]
    Evaluated with Dual-energy X-ray Absorptiometry to assess bone mineral density (g/cm2)

  6. Change from Baseline between and within groups comparison, in Aerobic Capacity [ Time Frame: 0 weeks ]
    Evaluated with the Balke treadmill protocol to assess aerobic capacity response (ml.kg 1.min 1)

  7. Change from Baseline between and within groups comparison, in Aerobic Functionality [ Time Frame: 0, 6,12 weeks ]
    Evaluated with the 6 minute Walk Test, in meters, to assess aerobic capacity

  8. Change from Baseline between and within groups comparison, in Physical Performance [ Time Frame: 0, 6, 12 weeks ]
    Evaluated with the Biodex (Peak Torke) to assess lower body strength

  9. Change from Baseline between and within groups comparison, in Physical Activity [ Time Frame: 0, 6, 12 weeks ]
    Evaluated with the Actigraph accelerometers, in Actigraph wGT3X-BT, during 7 days of a normal week, covering 5 days weeks and 2 days of weekend to estimate the levels of physical activity


Secondary Outcome Measures :
  1. Change from Baseline between and within groups comparison, in health-related quality of life [ Time Frame: 0, 6, 12 weeks ]
    Evaluated with the Short Form Health Survey 36 (SF-36V2) questionnaire, total score, to assess health-related quality of life

  2. Change from Baseline between and within groups comparison, in the perceived exertion during intervention [ Time Frame: 0, 6 weeks ]
    Evaluated with the Borg scale, in points between 6 and 20, to assess perceived exertion



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-III 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 I, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538119


Contacts
Contact: Catarina Gonçalves +351964526057 catarinajg3@gmail.com
Contact: Armando Raimundo +351917586909 ammr@uevora.pt

Locations
Portugal
Catarina Gonçalves Recruiting
São Bartolomeu de Messines, Faro, Portugal, 8375-127
Contact: Catarina Gonçalves, MSc    +351964526057    catarinajg3@gmail.com   
Contact: Armando Raimundo, Ph.D.    +351917586909    ammr@uevora.pt   
Principal Investigator: Catarina Gonçalves, MSc         
Principal Investigator: Armando Raimundo, Ph.D.         
Principal Investigator: Jorge Bravo, Ph.D.         
Sponsors and Collaborators
University of Évora
Investigators
Principal Investigator: Catarina Gonçalves University of Évora

Publications:
World Health Organisation. Global recommendations on physical activity for health. 2010

Responsible Party: Catarina Joaquim Gonçalves, Principal Investigator, University of Évora
ClinicalTrials.gov Identifier: NCT03538119     History of Changes
Other Study ID Numbers: CR_UEvora
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catarina Joaquim Gonçalves, University of Évora:
Cardiac Rehabilitation
High Intensity Interval Training
Exercise-based Rehabilitation
Secondary prevention
Sedentary Behavior