Phase III Cardiac Rehabilitation in Coronary Patients: High-intensity Interval Training or Moderate-intensity Continuous Training?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Change from Baseline between and within groups comparison in Muscle Strength
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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-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.
Arms & Interventions
High Intensity Interval Training Program
Three sessions of exercises will be performed weekly with duration of 30 min to 45 min, divided into warm up, aerobic exercise (4x4 high-intensity intervals at 85%-95%) and recovery.
Intervention: High Intensity Interval Training Program (Other)
Moderate Intensity Continuous Training Program
Three sessions of exercises will be performed weekly with duration of 45 min to 60 min, divided into warm up, aerobic exercise (continuous intensity at 70-75%HRpeak) and recovery.
Intervention: Moderate Intensity Continuous Training Program (Other)
Control Group
Usual care. The patients will receive nutritional counseling as well as physical activity.
Outcomes
Primary Outcomes
Change from Baseline between and within groups comparison in Muscle Strength
Time Frame: 0 weeks, 6 weeks, 6 months and 12 months
Evaluated with the Biodex (Peak Torque) to assess lower body muscle strength
Change from Baseline between and within groups comparison in Blood Pressure Profile
Time Frame: 0 weeks, 6 weeks, 6 months and 12 months
Systolic and diastolic blood pressure, in mmHg, and Basal Heart Rate, in heart beats per minute, to assess blood pressure profile.
Change from Baseline between and within groups comparison in Body Composition
Time Frame: 0 weeks, 6 weeks, 6 months and 12 months
Evaluated with the Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)
Change from Baseline between and within groups comparison in Physical Activity Levels
Time Frame: 0 weeks, 6 weeks, 6 months and 12 months
Patients were asked to wear a triaxial accelerometer (ActiGraph GT3X) on their hip placed anterior to the right iliac crest for 7 consecutive days during waking except when bathing or swimming. Acceleration data from the 3 planes were processed with ActiGraph software (ActiLife, version 6) using 15-s epochs (raw data recorded at 30 Hz) and the standard filter and were integrated into a vector magnitude count by taking the square root of the sum of squared axes (vertical, anterior-posterior, and medial-lateral).
Change from Baseline between and within groups comparison in Lipid Profile
Time Frame: 0 weeks, 6 weeks, 6 months and 12 months
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)
Change from Baseline between and within groups comparison in Aerobic Capacity
Time Frame: 0 weeks, 6 weeks, 6 months and 12 months
Evaluated with the 6 Minute Walking Test, in meters, to assess aerobic capacity
Secondary Outcomes
- Change from Baseline between and within groups comparison in Health-related Quality of Life(0 weeks, 6 weeks, 6 months and 12 months)
- Change from Baseline between and within groups comparison in Bone Composition(0 weeks, 6 weeks, 6 months and 12 months)
- Change from Baseline between and within groups comparison in Anxiety and Depression(0 weeks, 6 weeks, 6 months and 12 months)
- Change from Baseline between and within groups comparison in Sleep Quality(0 weeks, 6 weeks, 6 months and 12 months)
Investigators
Catarina Joaquim Gonçalves
Principal Investigator
University of Évora