NCT03796234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
Last Updated

September 17, 2020

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 2, 2019

Last Update Submit

September 15, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (18)

  • Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %

    baseline

  • Body composition: body fat in %, visceral fat in %, muscle mass in %, body water in %

    3 months

  • Weight (in kilograms)

    baseline

  • Weight (in kilograms)

    3 months

  • Body mass index

    baseline

  • +13 more secondary outcomes

Study Arms (2)

Dietary and physiotherapy

EXPERIMENTAL

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

Physiotherapy

EXPERIMENTAL

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

Interventions

Dietary and physiotherapyOTHER

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.

Dietary and physiotherapy
PhysiotherapyOTHER

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

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

DietPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaTherapeuticsRehabilitation

Study Officials

  • Elena Marques-Sule, PT, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Physiotherapy

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 8, 2019

Study Start

March 1, 2018

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

September 17, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)