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

• ClinicalTrials.gov Identifier: NCT03796234
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: September 17, 2020
• Sponsor: University of Valencia
• Information provided by (Responsible Party): Elena Marques-Sule, University of Valencia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Other: Dietary and physiotherapy; Other: Physiotherapy	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: July 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dietary and physiotherapy; 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.	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.
Experimental: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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).
3. 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).
4. 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).

Secondary Outcome Measures :

1. Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in % [ Time Frame: baseline ]
   Bioimpedanciometer OMRON HBF-500INT
2. Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in % [ Time Frame: 3 months ]
   Bioimpedanciometer OMRON HBF-500INT
3. Weight (in kilograms) [ Time Frame: baseline ]
   Weight (in kilograms)
4. Weight (in kilograms) [ Time Frame: 3 months ]
   Weight (in kilograms)
5. Body mass index [ Time Frame: baseline ]
   weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
6. Body mass index [ Time Frame: 3 months ]
   weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
7. Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm [ Time Frame: baseline ]
   Circumferences by using a measuring tape
8. Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm [ Time Frame: 3 months ]
   Circumferences by using a measuring tape
9. Triceps fat fold in mm [ Time Frame: Baseline ]
   Lipocalibre Holtain
10. Triceps fat fold in mm [ Time Frame: 3 months ]
    Lipocalibre Holtain
11. Physical activity [ Time Frame: baseline ]

    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.

12. Physical activity [ Time Frame: 3 months ]

    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.

13. Health related quality of life [ Time Frame: baseline ]
    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.
14. Health related quality of life [ Time Frame: 3 months ]
    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.
15. Anxiety [ Time Frame: baseline ]
    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).
16. Anxiety [ Time Frame: 3 months ]
    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).
17. Depression [ Time Frame: baseline ]
    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).
18. Depression [ Time Frame: 3 months ]
    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).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

University of Valencia

Valencia, Spain, 46010

Sponsors and Collaborators

University of Valencia

Investigators

• Principal Investigator: Elena Marques-Sule, PT, PhD; University of Valencia

More Information

• Responsible Party: Elena Marques-Sule, Doctor in Physiotherapy, University of Valencia
• ClinicalTrials.gov Identifier: NCT03796234
• Other Study ID Numbers: 147697976792
• First Posted: January 8, 2019
• Last Update Posted: September 17, 2020
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases