Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796234
• Other study ID #: 147697976792
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: January 2019
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Dietary and physiotherapy
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
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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline
Primary	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).	3 months
Primary	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).	baseline
Primary	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).	3 months
Secondary	Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %	Bioimpedanciometer OMRON HBF-500INT	baseline
Secondary	Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %	Bioimpedanciometer OMRON HBF-500INT	3 months
Secondary	Weight (in kilograms)	Weight (in kilograms)	baseline
Secondary	Weight (in kilograms)	Weight (in kilograms)	3 months
Secondary	Body mass index	weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2	baseline
Secondary	Body mass index	weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2	3 months
Secondary	Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm	Circumferences by using a measuring tape	baseline
Secondary	Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm	Circumferences by using a measuring tape	3 months
Secondary	Triceps fat fold in mm	Lipocalibre Holtain	Baseline
Secondary	Triceps fat fold in mm	Lipocalibre Holtain	3 months
Secondary	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.	baseline
Secondary	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.	3 months
Secondary	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.	baseline
Secondary	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.	3 months
Secondary	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	baseline
Secondary	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	3 months
Secondary	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	baseline
Secondary	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 a = .83 and HAD-D a = .87 (Vallejo, Rivera, Esteve-Vives and RodríguezMuñoz, 2012).	3 months