Utilization of Physical Activity Recommendations Among Patients of Cardiovascular Healthcare Centres in Eastern Slovakia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2020-02-23

Brief Summary

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The aims of this trial are:

(A) to determine and compare the indices of exercise recommendations compliance after exercise prescription according to digital training and decision support system as compared to exercise prescription following the standard informative procedure among patients with cardiovascular disease.

(B) to determine whether health literacy moderates effect of exercise prescription according to digital training and decision support system on the indices of exercise recommendations compliance among patients with cardiovascular disease.

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Detailed Description

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The trial will compare the utilization of physical activity recommendation between the standard lifestyle informative procedure and the digital training and decision system informative procedure.

We hypothesize that a higher rate of compliance between seven-day exercise report and physical activity recommendations will be observed in the experimental group compared with three-months waiting group.

The goal is to recruit patients with a stable diagnosis, clinically defined as sufficiently healthy to participate in an optimized (safe and monitored) exercise programme. Based on the experience with similar projects completed on Cardiovascular Health Centres (CHC) expected attrition rate is 25%. Such a value and 400 participants as a target recruitment number still allows to keep 150 participants in both groups and a power of 80% to detect the differences between groups and across the time at an α level of 0,05 (two-tailed).

The trial will be supervised by a Data Safety and Monitoring Board consisting of one independent, internationally recognized clinical researcher, one representative (cardiologist) from each cooperating Cardiovascular Healthcare Centre as an advisor and experts in health psychology, exercise psychology, trial management and exercise physiology. The Board will be the policy and decision-making authority of the trial.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

Patients randomized into the experimental group will undergo behavioural counselling. During the 30-minute long consultation patients will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, except recommendations for physical activities. This domain will be consulted exclusively through the digital training and decision support system EXPERT tool.

Group Type EXPERIMENTAL

The EAPC Exercise Prescription (EXPERT) Tool

Intervention Type BEHAVIORAL

During the 30-minute long consultation subjects will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, except recommendations for physical activities. This domain will be consulted exclusively through the digital training and decision support tool.

The EXPERT tool is an interactive digital training and decision support system for optimized exercise prescription in cardiovascular disease patients. The EXPERT tool was designed to provide optimized exercise prescription based on detailed overview of patient´s diagnosis, prognostics, complications and medication.

Control group

Patients randomized into the control group will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, also in the domain of recommendations for physical activities.

Group Type ACTIVE_COMPARATOR

Standard Cardio-Care Lifestyle Counselling

Intervention Type BEHAVIORAL

During the 30-minute long consultation subjects will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions also in the domain of recommendations for physical activities. The exercise prescription process during consultation will be constructed in accordance with published guidelines and recommendations for secondary prevention of cardiovascular diseases.

Interventions

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The EAPC Exercise Prescription (EXPERT) Tool

During the 30-minute long consultation subjects will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, except recommendations for physical activities. This domain will be consulted exclusively through the digital training and decision support tool.

The EXPERT tool is an interactive digital training and decision support system for optimized exercise prescription in cardiovascular disease patients. The EXPERT tool was designed to provide optimized exercise prescription based on detailed overview of patient´s diagnosis, prognostics, complications and medication.

Intervention Type BEHAVIORAL

Standard Cardio-Care Lifestyle Counselling

During the 30-minute long consultation subjects will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions also in the domain of recommendations for physical activities. The exercise prescription process during consultation will be constructed in accordance with published guidelines and recommendations for secondary prevention of cardiovascular diseases.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* receive information about perceived health benefits and risks connected with participation in the study based on disease severity from the treating cardiologist about participation in the study,
* willingness to accept randomization and participation in the assessment procedures,
* at recruitment moment, medical record of one or more below-listed cardiovascular diagnosis: coronary artery disease, coronary artery bypass graft surgery, or endoscopic traumatic coronary artery bypass graft surgery, compensated heart failure, cardiomyopathy, intermittent claudication, implantable cardioverter defibrillator or pacemaker, ventricular assist devices, heart transplantation, valve disease or surgery, congenital heart disease and non-severe pulmonary hypertension.

Exclusion Criteria

* include the presence of below-listed specific cardiovascular conditions, significantly increasing risks of sudden cardiovascular events, also identified as potential contraindications of physical activity on cardiovascular patients: uncontrolled hypertension, decompensated heart failure, severe and symptomatic aortic stenosis, uncontrolled arrhythmia, severe pulmonary hypertension, acute coronary syndromes, acute myocarditis, endocarditis, or pericarditis, aortic dissection, Marfan syndrome or presence of malignancy (active cancer) or life-treating disease, bed-ridden status, participation or plan to participate in other study during trial execution or plan to move during the trial execution.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No