Clinical trial NCT03796234: Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease
Official title: Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease With Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Adherence to the mediterranean diet
timeFrame: baseline
measure: Adherence to the mediterranean diet
timeFrame: 3 months
measure: Food consumption frequency questonnaire
timeFrame: baseline
measure: Food consumption frequency questonnaire
timeFrame: 3 months
Secondary outcomes:
measure: Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
timeFrame: baseline
measure: Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %
timeFrame: 3 months
measure: Weight (in kilograms)
timeFrame: baseline
measure: Weight (in kilograms)
timeFrame: 3 months
measure: Body mass index
timeFrame: baseline
measure: Body mass index
timeFrame: 3 months
measure: Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
timeFrame: baseline
measure: Circumferences: abdominal circumference in cm, hip circumference in cm, arm circumference in cm, calf circumference in cm
timeFrame: 3 months
measure: Triceps fat fold in mm
timeFrame: Baseline
measure: Triceps fat fold in mm
timeFrame: 3 months
measure: Physical activity
timeFrame: baseline
measure: Physical activity
timeFrame: 3 months
measure: Health related quality of life
timeFrame: baseline
measure: Health related quality of life
timeFrame: 3 months
measure: Anxiety
timeFrame: baseline
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: baseline
measure: Depression
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Elena Marques-Sule, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: