- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03796234
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Valencia, Espanha, 46010
- University of Valencia
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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.
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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.
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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.
|
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Adherence to the mediterranean diet
Prazo: 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).
|
baseline
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Adherence to the mediterranean diet
Prazo: 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 months
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Food consumption frequency questonnaire
Prazo: baseline
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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).
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baseline
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Food consumption frequency questonnaire
Prazo: 3 months
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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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Prazo: baseline
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Bioimpedanciometer OMRON HBF-500INT
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baseline
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Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
Prazo: 3 months
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Bioimpedanciometer OMRON HBF-500INT
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3 months
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Weight (in kilograms)
Prazo: baseline
|
Weight (in kilograms)
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baseline
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Weight (in kilograms)
Prazo: 3 months
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Weight (in kilograms)
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3 months
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Body mass index
Prazo: baseline
|
weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
|
baseline
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Body mass index
Prazo: 3 months
|
weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2
|
3 months
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Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Prazo: baseline
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Circumferences by using a measuring tape
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baseline
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Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
Prazo: 3 months
|
Circumferences by using a measuring tape
|
3 months
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Triceps fat fold in mm
Prazo: Baseline
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Lipocalibre Holtain
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Baseline
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Triceps fat fold in mm
Prazo: 3 months
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Lipocalibre Holtain
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3 months
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Physical activity
Prazo: baseline
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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
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Physical activity
Prazo: 3 months
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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
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Health related quality of life
Prazo: baseline
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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.
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baseline
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Health related quality of life
Prazo: 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.
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3 months
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Anxiety
Prazo: baseline
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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).
|
baseline
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Anxiety
Prazo: 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).
|
3 months
|
Depression
Prazo: 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).
|
baseline
|
Depression
Prazo: 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).
|
3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elena Marques-Sule, PT, PhD, University of Valencia
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 147697976792
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