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

Pavol Jozef Safarik University

Status: Withdrawn

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Standard Cardio-Care Lifestyle Counselling; Behavioral: The EAPC Exercise Prescription (EXPERT) Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03329053

PJSU-1/0825/17

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: The EAPC Exercise Prescription (EXPERT) Tool

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Cardio-Care Lifestyle Counselling