Coronary Artery DiseaseNCT03796234
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease
A study testing Dietary and physiotherapy and Physiotherapy in people with Coronary Artery Disease, run by University of Valencia at 1 site in Spain.
Trial summary
A multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention. Educational lectures on nutrition and high intensity interval training will be developed in old patients with chronic heart disease. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dietary and physiotherapy and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 30 Jul 2018
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- infarction or angina pectoris.
- At least six months elapsed since the diagnosis of heart disease at the time of the start of the study.
- Be physically and cognitively able to complete the evaluations and the program.
Who cannot join
- Present another type of cardiac disease different from ischemic heart disease.
- Present any physical or psychiatric condition that prevents the normal performance of the evaluations and the program.
- Mobility problems to attend reassessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention
A multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention. Educational lectures on nutrition and high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.
Read the detailed description
A multidisciplinary program based on high intensity interval training and diet education will be carried out for 3 months for patients with coronary artery disease with percutaneous coronary intervention. Three educational lectures on nutrition and a 3-month high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.
- Conditions
- Coronary Artery Disease
- Being tested
- Dietary and physiotherapy, Physiotherapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and physiotherapyOther
3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
PhysiotherapyOther
A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
| Study group | Role | What they receive |
|---|---|---|
| Dietary and physiotherapy | Experimental | A multidisciplinary program was developed. 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. Receives: Other: Dietary and physiotherapy |
| Physiotherapy | Experimental | A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the mediterranean diet
Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
Measured: baseline
Adherence to the mediterranean diet
Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
Measured: 3 months
Food consumption frequency questonnaire
Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
Measured: baseline
Food consumption frequency questonnaire
Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
Measured: 3 months
Secondary outcomes (18)
Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Bioimpedanciometer OMRON HBF-500INT
Measured: baseline
Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Bioimpedanciometer OMRON HBF-500INT
Measured: 3 months
Weight (in kilograms)
Weight (in kilograms)
Measured: baseline
Weight (in kilograms)
Weight (in kilograms)
Measured: 3 months
Body mass index
weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
Measured: baseline
Body mass index
weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
Measured: 3 months
Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Circumferences by using a measuring tape
Measured: baseline
Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Circumferences by using a measuring tape
Measured: 3 months
Triceps fat fold in mm
Lipocalibre Holtain
Measured: Baseline
Triceps fat fold in mm
Lipocalibre Holtain
Measured: 3 months
Physical activity
International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
Measured: baseline
Physical activity
International physical activity questionnaire: it has 9 items and provides information on the time spent while walking, in activities of low, moderate and vigorous intensity and in sedentary activities. Based on the estimated METS consumed, the IPAQ divides the subjects into three levels or categories: Low, moderate and high physical activity.
The score of the different types of activity is expressed in METS-minutes per week.
Measured: 3 months
Health related quality of life
Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
Measured: baseline
Health related quality of life
Short-form 36: the questionnaire is composed of 36 questions that value both positive and negative health status. It was developed from an extensive battery of questionnaires employed at WHO, which included 40 concepts related to health. The questionnaire contains 8 scales, which represent the concepts of health most frequently used in the main health questionnaires. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role, Mental health. The scores of each of the 8 dimensions of the SF-36 oscillate between 0 and 100. A result of 100 indicates optimal health and 0 would reflect a very poor state of health.
Measured: 3 months
Anxiety
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
Measured: baseline
Anxiety
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
Measured: 3 months
Depression
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
Measured: baseline
Depression
Hospital anxiety and depression questionnaire: the questionnaire includes 14 questions regarding the depressant and anxious symptoms of the patient. Two subsets of 7 items each, on Likert scale 0-3. For anxiety HAD-A sum of odd items (1,3,5,7,9,11,13), for depression HAD-D sum of even items (2,4,6,8,10,12,14 ), with a score range in each subscale of 0-21. A higher score means greater anxiety and depression. For both subscales, scores higher than eleven would indicate "case" and greater than eight would be considered "probable case". The internal consistency for the Spanish population is HAD-A α = .83 and HAD-D α = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Marques-Sule, University of Valencia
- Investigators
- Elena Marques-Sule, PT, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796234
- Sponsor's protocol ID
- 147697976792
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03796234
- Acronym / sponsor ID
- 147697976792
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 8 Jan 2019 (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.
A multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention. Educational lectures on nutrition and high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.
Detailed description
A multidisciplinary program based on high intensity interval training and diet education will be carried out for 3 months for patients with coronary artery disease with percutaneous coronary intervention. Three educational lectures on nutrition and a 3-month high intensity interval training will be developed in old patients with chronic heart disease. A control group will not develop any program. Effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary and physiotherapy | Experimental | Other: Dietary and physiotherapyA multidisciplinary program was developed. 3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. |
| Physiotherapy | Experimental | Other: PhysiotherapyA 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- infarction or angina pectoris.
- At least six months elapsed since the diagnosis of heart disease at the time of the start of the study.
- Be physically and cognitively able to complete the evaluations and the program.
Key exclusion criteria (3 listed)
- Present another type of cardiac disease different from ischemic heart disease.
- Present any physical or psychiatric condition that prevents the normal performance of the evaluations and the program.
- Mobility problems to attend reassessments.
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 |
|---|---|---|
| Dietary and physiotherapy3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. | Other | Dietary and physiotherapy |
| PhysiotherapyA 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests. | Other | Physiotherapy |
Primary outcome
Adherence to the mediterranean diet
Time frame: baseline
Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
Adherence to the mediterranean diet
Time frame: 3 months
Test of adherence to the mediterranean diet, which consists of 14 questions related to the Mediterranean diet. Depending on the answer of the question it can be obtained 1 point or 0 points, being the value of each item 0 or 1. If the sum of the points is 9 or higher the subject has a good adhesion to the mediterranean diet. If it is less than 9 points is considered bad adhesion. The range can vary between 0 points (minimum adhesion) and 14 points (maximum adhesion) (PREDIMED, 2017).
Food consumption frequency questonnaire
Time frame: baseline
Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
Food consumption frequency questonnaire
Time frame: 3 months
Food consumption frequency questionnaire: registers the number of times/week or the number of times/month a series of foods is consumed, so that information about the foods the individual consumes most frequently during the week can be obtained. The list of foods that are part of the questionnaire is made up of those most common among the population, with a total of 45 items (yoghurts, fish, fruits, etc.). It also includes a table called Table of Weight of the Item Ration (PRI), in which the weight of the ration of each item is collected to facilitate the completion of the questionnaire (Trinidad et al., 2008).
18 secondary outcomes
Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Time frame: baseline
Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Time frame: 3 months
Weight (in kilograms)
Time frame: baseline
Weight (in kilograms)
Time frame: 3 months
Body mass index
Time frame: baseline
Body mass index
Time frame: 3 months
Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Time frame: baseline
Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Time frame: 3 months
Triceps fat fold in mm
Time frame: Baseline
Triceps fat fold in mm
Time frame: 3 months
Physical activity
Time frame: baseline
Physical activity
Time frame: 3 months
Health related quality of life
Time frame: baseline
Health related quality of life
Time frame: 3 months
Anxiety
Time frame: baseline
Anxiety
Time frame: 3 months
Depression
Time frame: baseline
Depression
Time frame: 3 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 Sep 2020.
- 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.
Elena Marques-Sule, PT, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and physiotherapy and Physiotherapy in people with Coronary Artery Disease, run by University of Valencia at 1 site in Spain.
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 3 inclusion and 3 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 Sep 2020. 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 Spain. 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?
Adherence to the mediterranean diet (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.