Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease

Coronary Heart Disease Clinical Trial

Official title:

Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753829
• Other study ID #: ASV-88
• Status: Completed
• Phase: N/A
• First received: April 18, 2016
• Last updated: April 27, 2016
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial Summary

The sample of this randomized controlled trial was obtained in the Cardiovascular Prevention and Rehabilitation Unit, of the Hospital Centre of Porto, Santo Antonio General Hospital. The target population was individuals who have completed the training phase of cardiovascular rehabilitation program, volunteers and referenced by the responsible for the service.

This study has as main objective to analyze the influence of a specific exercise program, maintenance phase of cardiovascular rehabilitation , in home care context, for a period of 6 months, using a virtual format (computer and Kinect) or a conventional format (paper manual) in subjects with coronary artery disease. It was intended to analyze the immediate effect of exercise program on body composition and food consumption patterns, functional muscle strength of lower limb, level of physical activity: total volume of activity as well as the profile of this intensity, kyphotic index, balance, cognitive and executive function, as well as in the quality of life.

The aim is also to examine the effects, approximately 3 months after the end of the exercise program, in the lipid profile, the level of physical activity: total volume of activity as well as the profile of this intensity and cardiovascular fitness: maximum double product ; metabolic equivalents; and proof and recovery time.

The individuals were distributed at random, every 3 individuals, using the capabilities of Microsoft Excel 2010 RANDBETWEEN command, by three groups: the experimental group 1- a cardiovascular rehabilitation program, in home care context, using a computer and Kinect, virtual format, the experimental group 2- in cardiovascular rehabilitation program, in home care context, using a paper-based manual, conventional format, and control group-only subject to education for cardiovascular risk factors.

The program defined 3 training sessions per week. The rehabilitation program was oriented by the guidelines for exercise prescription.

Participants perform the a program of specific exercises independently and individually, with remote supervision, using communication (phone, email, etc.) and a routine scheduled individual meetings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• coronary artery disease diagnosed and stabilized

• both sexes

• aged between 40 and 75 years

• individuals were to have performed and completed the training phase of cardiovascular rehabilitation

• individuals should have a computer with at least Microsoft Windows 7

Exclusion Criteria:

• heart surgery

• individuals whose stress test did not end for maximum fatigue

• individuals in gestation period or wishing to become pregnant

• individuals classified as cardiovascular high-risk

• individuals with pacemakers or with severe neurological, musculoskeletal or respiratory diseases and metabolic unbalanced disease or reported dementia, cardiomyopathies, history of cardio respiratory arrest don't associated with acute myocardial infarction or cardiac procedures

• individuals with significant visual and auditory deficits not compensated

• individuals illiterate and / or without knowledge of Portuguese language

• Individuals who were in, or wanted to do gyms or other regular exercise programs during the study

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction: Rehabilitation Phase
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• Cardiovascular rehabilitation program using Kinect of Xbox
Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%. It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.
• Cardiovascular rehabilitation program using paper manual
Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%. It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Other:
• Educational component
It was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ágata Sofia da Silva Vieira

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular fitness using the stress test		9 months	No
Primary	Physical activity using the accelerometer		9 months	No
Primary	Quality of life using Macnew (heart disease health-related quality of life questionnaire)		6 months	No
Primary	Lipid Profile using laboratory tests		9 months	No
Primary	Quality of life using EADS-21 (depression, anxiety and stress scale)		6 months	No
Secondary	Balance using the One leg standing test		6 months	No
Secondary	Balance using Star Excursion Balance Test		6 months	No
Secondary	Kyphotic index using the flexicurve		6 months	No
Secondary	Cognitive function using the Trail Making Test		6 months	No
Secondary	Cognitive function using the Verbal Digit Span Test		6 months	No
Secondary	Cognitive function using the Stroop Test		6 months	No
Secondary	Weight using the balance of bioimpedance		6 months	No
Secondary	Total fat mass using the balance of bioimpedance		6 months	No
Secondary	Fat mass of the trunk using the balance of bioimpedance		6 months	No
Secondary	Lean body mass using the balance of bioimpedance		6 months	No
Secondary	Waist hip ratio using the tape measure		6 months	No
Secondary	Waist height ratio using the tape measure		6 months	No
Secondary	Food consumption patterns using the food frequency questionnaire		6 months	No
Secondary	Functional muscle strength of lower limb using the Sit-to-stand test		6 months	No