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Completed

NCT Number: NCT03796234

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

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.

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Key information

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary and physiotherapy

Other

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

Other

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2019
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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