Patients With Coronary Artery DiseaseNCT03538119
Comparison Between HIIT and MICT on the Phase III of Cardiac Rehabilitation
A study testing High Intensity Interval Training Program and Moderate Intensity Continuous Training Program in people with Patients With Coronary Artery Disease, run by University of Évora at 1 site in Portugal.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With Coronary Artery Disease
- What is being tested?
- High Intensity Interval Training Program and Moderate Intensity Continuous Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Dec 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Cardiac Rehabilitation in Coronary Patients: High-intensity Interval Training or Moderate-intensity Continuous Training?
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.
Read the 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.
- Conditions
- Patients With Coronary Artery Disease
- Being tested
- High Intensity Interval Training Program, Moderate Intensity Continuous Training Program
- Keywords
- Cardiac Rehabilitation, High Intensity Interval Training, Moderate Intensity Continuous Training, Secondary prevention, Cardiovascular Risk Factors, Exercise-based Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training ProgramOther
Also called HIIT
The HIIT group performed 4 × 4-minute high-intensity intervals at 85%-95% HRpeak followed by a 1-minute recovery interval at 40% HRpeak, predicted with a supervised graded exercise test on a treadmill with the Bruce protocol. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of HRpeak) and a 3 to 5 minute calm return period at 50% of the HRpeak.
The supervised sessions will take place on 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.
Moderate Intensity Continuous Training ProgramOther
Also called MICT
The MICT protocol (usual care) consisted of a continuous bout of moderate-intensity exercise to elicit 70-75% HRpeak, rating of perceived exertion 3 to 5 (fairly light to somewhat hard), for 27.5 minutes to equate the energy expenditure with the HIIT protocol. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of HRpeak) and a 3 to 5 minute calm return period at 50% of the HRpeak.
The supervised sessions will take place on 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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training Program | Experimental | 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. Receives: Other: High Intensity Interval Training Program |
| Moderate Intensity Continuous Training Program | Experimental | 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. Receives: Other: Moderate Intensity Continuous Training Program |
| Control Group | No intervention | Usual care. The patients will receive nutritional counseling as well as physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline between and within groups comparison in Blood Pressure Profile
Systolic and diastolic blood pressure, in mmHg, and Basal Heart Rate, in heart beats per minute, to assess blood pressure profile.
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Lipid Profile
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)
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Body Composition
Evaluated with the Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Aerobic Capacity
Evaluated with the 6 Minute Walking Test, in meters, to assess aerobic capacity
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Muscle Strength
Evaluated with the Biodex (Peak Torque) to assess lower body muscle strength
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Physical Activity Levels
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).
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Secondary outcomes (4)
Change from Baseline between and within groups comparison in Health-related Quality of Life
Evaluated with the Short Form Health Survey 36 (SF-36V2) questionnaire, total score, to assess health-related quality of life. The questionnaire consisted of the rating scale, Short Form 36 (SF-36 Quality Metric, Lincoln, Rhode Island, USA), with eight domains: physical functioning, role-physical, role-emotional, social functioning, mental health, vitality, bodily pain and general health. This instrument addresses health concepts from the patient's perspective and the scores range from 0 (worst) to 100 (best).
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Anxiety and Depression
Evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire, total score, to assess health-related anxiety and depression levels. The total HADS score ranged between 0-42 with 0-14 being considered as low, 15-28 considered as moderate, and 29-42 being considered as high. For each subscale (anxiety and depression subscales), the scores ranged between 0 to 21, where 0-7 was considered low, 8-14 being moderate, while 15-21 was considered high.
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Bone Composition
Evaluated with Dual-energy X-ray Absorptiometry to assess bone mineral density (g/cm2)
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Sleep Quality
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 analyze sleep quality. 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 sleeping hours. 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).
Measured: 0 weeks, 6 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start19 Dec 2018
- Primary completion30 Oct 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Patients With Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Joaquim Gonçalves, University of Évora
- Investigators
- Catarina Gonçalves, Principal investigator, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538119
- Sponsor's protocol ID
- CR_UEvora
- Status last verified
- Oct 2023
- First submitted
- 15 May 2018
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung ME, Bourne JE, Little JP. Where does HIT fit? An examination of the affective response to high-intensity intervals in comparison to continuous moderate- and continuous vigorous-intensity exercise in the exercise intensity-affect continuum. PLoS One. 2014 Dec 8;9(12):e114541. doi: 10.1371/journal.pone.0114541. eCollection 2014.
PubMed 25486273Heisz JJ, Tejada MG, Paolucci EM, Muir C. Enjoyment for High-Intensity Interval Exercise Increases during the First Six Weeks of Training: Implications for Promoting Exercise Adherence in Sedentary Adults. PLoS One. 2016 Dec 14;11(12):e0168534. doi: 10.1371/journal.pone.0168534. eCollection 2016.
PubMed 27973594Bartlett JD, Close GL, MacLaren DP, Gregson W, Drust B, Morton JP. High-intensity interval running is perceived to be more enjoyable than moderate-intensity continuous exercise: implications for exercise adherence. J Sports Sci. 2011 Mar;29(6):547-53. doi: 10.1080/02640414.2010.545427.
PubMed 21360405Little JP, Jung ME, Wright AE, Wright W, Manders RJ. Effects of high-intensity interval exercise versus continuous moderate-intensity exercise on postprandial glycemic control assessed by continuous glucose monitoring in obese adults. Appl Physiol Nutr Metab. 2014 Jul;39(7):835-41. doi: 10.1139/apnm-2013-0512. Epub 2014 Feb 18.
PubMed 24773254Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.
PubMed 22289907Martinez N, Kilpatrick MW, Salomon K, Jung ME, Little JP. Affective and Enjoyment Responses to High-Intensity Interval Training in Overweight-to-Obese and Insufficiently Active Adults. J Sport Exerc Psychol. 2015 Apr;37(2):138-49. doi: 10.1123/jsep.2014-0212.
PubMed 25996105Oliveira BR, Slama FA, Deslandes AC, Furtado ES, Santos TM. Continuous and high-intensity interval training: which promotes higher pleasure? PLoS One. 2013 Nov 26;8(11):e79965. doi: 10.1371/journal.pone.0079965. eCollection 2013.
PubMed 24302993Wisloff U, Ellingsen O, Kemi OJ. High-intensity interval training to maximize cardiac benefits of exercise training? Exerc Sport Sci Rev. 2009 Jul;37(3):139-46. doi: 10.1097/JES.0b013e3181aa65fc.
PubMed 19550205Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
PubMed 26180873Goncalves C, Raimundo A, Abreu A, Pais J, Bravo J. Effects of High-Intensity Interval Training vs Moderate-Intensity Continuous Training on Body Composition and Blood Biomarkers in Coronary Artery Disease Patients: A Randomized Controlled Trial. Rev Cardiovasc Med. 2024 Mar 11;25(3):102. doi: 10.31083/j.rcm2503102. eCollection 2024 Mar.
PubMed 39076951Goncalves C, Bravo J, Pais J, Abreu A, Raimundo A. Improving Health Outcomes in Coronary Artery Disease Patients with Short-Term Protocols of High-Intensity Interval Training and Moderate-Intensity Continuous Training: A Community-Based Randomized Controlled Trial. Cardiovasc Ther. 2023 Dec 18;2023:6297302. doi: 10.1155/2023/6297302. eCollection 2023.
PubMed 38146531
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Cardiac Rehabilitation in Coronary Patients: High-intensity Interval Training or Moderate-intensity Continuous Training?
- ClinicalTrials.gov ID
- NCT03538119
- Acronym / sponsor ID
- CR_UEvora
- Conditions
- Patients With Coronary Artery Disease
- Keywords
- Cardiac Rehabilitation, High Intensity Interval Training, Moderate Intensity Continuous Training, Secondary prevention, Cardiovascular Risk Factors, Exercise-based Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training Program | Experimental | Other: High Intensity Interval Training ProgramThree 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. |
| Moderate Intensity Continuous Training Program | Experimental | Other: Moderate Intensity Continuous Training ProgramThree 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. |
| Control Group | No intervention | –Usual care. The patients will receive nutritional counseling as well as physical activity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training ProgramAlso: HIITThe HIIT group performed 4 × 4-minute high-intensity intervals at 85%-95% HRpeak followed by a 1-minute recovery interval at 40% HRpeak, predicted with a supervised graded exercise test on a treadmill with the Bruce protocol. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of HRpeak) and a 3 to 5 minute calm return period at 50% of the HRpeak. The supervised sessions will take place on 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 | High Intensity Interval Training Program |
| Moderate Intensity Continuous Training ProgramAlso: MICTThe MICT protocol (usual care) consisted of a continuous bout of moderate-intensity exercise to elicit 70-75% HRpeak, rating of perceived exertion 3 to 5 (fairly light to somewhat hard), for 27.5 minutes to equate the energy expenditure with the HIIT protocol. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of HRpeak) and a 3 to 5 minute calm return period at 50% of the HRpeak. The supervised sessions will take place on 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 | Moderate Intensity Continuous Training Program |
Primary outcome
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 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 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 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
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 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).
4 secondary outcomes
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
Change from Baseline between and within groups comparison in Anxiety and Depression
Time frame: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Bone Composition
Time frame: 0 weeks, 6 weeks, 6 months and 12 months
Change from Baseline between and within groups comparison in Sleep Quality
Time frame: 0 weeks, 6 weeks, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 25486273Jung ME, Bourne JE, Little JP. Where does HIT fit? An examination of the affective response to high-intensity intervals in comparison to continuous moderate- and continuous vigorous-intensity exercise in the exercise intensity-affect continuum. PLoS One. 2014 Dec 8;9(12):e114541. doi: 10.1371/journal.pone.0114541. eCollection 2014.
- Background: PubMed 27973594Heisz JJ, Tejada MG, Paolucci EM, Muir C. Enjoyment for High-Intensity Interval Exercise Increases during the First Six Weeks of Training: Implications for Promoting Exercise Adherence in Sedentary Adults. PLoS One. 2016 Dec 14;11(12):e0168534. doi: 10.1371/journal.pone.0168534. eCollection 2016.
- Background: PubMed 21360405Bartlett JD, Close GL, MacLaren DP, Gregson W, Drust B, Morton JP. High-intensity interval running is perceived to be more enjoyable than moderate-intensity continuous exercise: implications for exercise adherence. J Sports Sci. 2011 Mar;29(6):547-53. doi: 10.1080/02640414.2010.545427.
- Background: PubMed 24773254Little JP, Jung ME, Wright AE, Wright W, Manders RJ. Effects of high-intensity interval exercise versus continuous moderate-intensity exercise on postprandial glycemic control assessed by continuous glucose monitoring in obese adults. Appl Physiol Nutr Metab. 2014 Jul;39(7):835-41. doi: 10.1139/apnm-2013-0512. Epub 2014 Feb 18.
- Background: PubMed 22289907Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.
- Background: PubMed 25996105Martinez N, Kilpatrick MW, Salomon K, Jung ME, Little JP. Affective and Enjoyment Responses to High-Intensity Interval Training in Overweight-to-Obese and Insufficiently Active Adults. J Sport Exerc Psychol. 2015 Apr;37(2):138-49. doi: 10.1123/jsep.2014-0212.
- Background: PubMed 24302993Oliveira BR, Slama FA, Deslandes AC, Furtado ES, Santos TM. Continuous and high-intensity interval training: which promotes higher pleasure? PLoS One. 2013 Nov 26;8(11):e79965. doi: 10.1371/journal.pone.0079965. eCollection 2013.
- Background: PubMed 19550205Wisloff U, Ellingsen O, Kemi OJ. High-intensity interval training to maximize cardiac benefits of exercise training? Exerc Sport Sci Rev. 2009 Jul;37(3):139-46. doi: 10.1097/JES.0b013e3181aa65fc.
- Background: PubMed 26180873Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
- Derived from this study: PubMed 39076951Goncalves C, Raimundo A, Abreu A, Pais J, Bravo J. Effects of High-Intensity Interval Training vs Moderate-Intensity Continuous Training on Body Composition and Blood Biomarkers in Coronary Artery Disease Patients: A Randomized Controlled Trial. Rev Cardiovasc Med. 2024 Mar 11;25(3):102. doi: 10.31083/j.rcm2503102. eCollection 2024 Mar.
- Derived from this study: PubMed 38146531Goncalves C, Bravo J, Pais J, Abreu A, Raimundo A. Improving Health Outcomes in Coronary Artery Disease Patients with Short-Term Protocols of High-Intensity Interval Training and Moderate-Intensity Continuous Training: A Community-Based Randomized Controlled Trial. Cardiovasc Ther. 2023 Dec 18;2023:6297302. doi: 10.1155/2023/6297302. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Gonçalves principal investigator
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training Program and Moderate Intensity Continuous Training Program in people with Patients With Coronary Artery Disease, run by University of Évora at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline between and within groups comparison in Blood Pressure Profile (time frame: 0 weeks, 6 weeks, 6 months and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538119, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.