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

Sponsor
University of Évora (Other)
Overall Status
Recruiting
CT.gov ID
NCT03538119
Collaborator
(none)
80
1
3
54.3
1.5

Study Details

Study Description

Brief Summary

The increase in the prevalence of cardiovascular diseases (CVD), 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 MCT 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
  • Other: High intensity interval training program
  • Other: Moderate continuous training program
N/A

Detailed Description

According to WHO (1) cardiovascular diseases (CVD) are the number 1 cause of death globally:

an estimated 17.5 million people died from CVD in 2012, representing 31% of all global deaths. In 2013 there were 1.9 million deaths resulting from CVD of the circulatory system in the EU-28, which was correspondent to 37.5 % of all deaths considerably higher than the second most prevalent cause of death, cancer.

In Portugal, cardiovascular diseases lead to morbidity and mortality rates, which makes evident the importance in the Public Health scenario and the need to implement measures aimed at primary and secondary prevention. In 2004, cardiovascular diseases signify 39% of all causes of death, since then a reduction in these values has been recorded and, according to more recent data (2013), the values are around 29.5%.

As these pathologies are associated, among other causes, with aging, the Alentejo emerges as one of the regions where the prevalence of these pathologies is greater. In fact, since Alentejo is the oldest region, it becomes an authentic Living Lab. In this way, this study intends to study the effects of different types of cardiac rehabilitation (CR) programs, emphasizing in particular the use of a high intensity interval program that we will compare with a traditional program.

For the program will be recruited patients who have been admitted in the Cardiology Services at Espírito Santo Hospital in Évora. Participants of both sexes will be included, between 18 and 80 years of age, meeting the criteria for low or moderate risk, class B for participation and exercise supervision, absence of signs/symptoms after cardiac surgery, with a left ventricular ejection fraction greater than 40%, according to the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation.

Those who meet the inclusion criteria will be evaluated in a clinical context in order to determine the capacity to integrate phase III of CR. This phase will last about 6 weeks, will be held at the Nursing School located at the Espírito Santo Hospital.

The sessions will be supervised and will take place on a cycloergometer 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.

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

During the intervention, the workload, FC and the subjective effort perception scale (EPE - Borg) will be recorded throughout each session, every minute for the HIIT training and all other minutes for the MTC. During the intervention the load will be adjusted to obtain the target FC.

After the exercise session, participants will complete 1 of 18 items of the Physical Activity and Pleasure Scale (PACES) on a weekly basis in which subjects rate their appreciation for the exercise of that week on a seven-point scale.

In the same period, the usual medical recommendations for cardiac rehabilitation through exercise will be provided to the Control Groups (phase III).

When subjects complete phase III CR, they will be given guidelines on exercise and nutrition. The intention is that participants after the program have adopted a healthy lifestyle, where the practice of physical exercise is a reality. The intention is also to verify if participation in one of the different exercise programs that have been implemented, in phase III of CR, can possibly provide better results both in maintaining good life habits and also in reducing the time in the sedentary activities, the "Active Couch Potato" phenomenon. More than solving a health problem at a certain stage of a subject's life, it is intended to consolidate healthy habits of life.

In order to verify which type of program allows to modify the habits of life towards the increase of the practice of physical activity, as well as the maintenance of these habits, we will carry out a follow-up at 6 months and one year after the beginning of the intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cardiac Rehabilitation: The Impact of High Intensity Interval Training vs. Moderate Continuous Training in Phase III
Actual Study Start Date :
Dec 19, 2018
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • MCT
  • No Intervention: Control Group

    Usual care. The patients will receive nutritional counseling as well as physical activity.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline between and within groups comparison, in Cardiac Profile [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [0, 6 weeks]

      Evaluated with the Borg scale, in points between 6 and 20, to assess perceived exertion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catarina Gonçalves São Bartolomeu de Messines Faro Portugal 8375-127

    Sponsors and Collaborators

    • University of Évora

    Investigators

    • Principal Investigator: Catarina Gonçalves, University of Évora

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Catarina Joaquim Gonçalves, Principal Investigator, University of Évora
    ClinicalTrials.gov Identifier:
    NCT03538119
    Other Study ID Numbers:
    • CR_UEvora
    First Posted:
    May 25, 2018
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Principal Investigator, University of Évora

    Study Results

    No Results Posted as of Nov 8, 2021