Clinical trial NCT03329053: Utilization of Physical Activity Recommendations Among Patients of Cardiovascular Healthcare Centres in Eastern Slovakia
Official title: A Randomized Controlled Trial to Evaluate Utilization of Physical Activity Recommendations Among Patients of Cardiovascular Healthcare Centres in Eastern Slovakia: Study Design and Rationale of the AWATAR Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: exercise prescription
digital exercise prescription tool
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
Collaborators: name: University of Groningen
First posted: 2017-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in exercise recommendations compliance at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
Secondary outcomes:
measure: Change in body weight at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
measure: Change in body height at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
measure: Change in Body Mass Index at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
measure: Change in leisure time physical activities at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
measure: Change in clinical data at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
measure: Change in health literacy at three months
timeFrame: Before the intervention and 1-5 days after three months follow up
Other outcomes:
Locations:
city: Košice
country: Slovakia
facility: Cardiology and Internal Medicine Ambulance
Study officials:
affiliation: Institute of Physical Education and Sport, Pavol Jozef Safarik University
name: Alena Bukova, PhD.
role: STUDY_CHAIR
References:
citation: Hansen D, Dendale P, Coninx K, Vanhees L, Piepoli MF, Niebauer J, Cornelissen V, Pedretti R, Geurts E, Ruiz GR, Corra U, Schmid JP, Greco E, Davos CH, Edelmann F, Abreu A, Rauch B, Ambrosetti M, Braga SS, Barna O, Beckers P, Bussotti M, Fagard R, Faggiano P, Garcia-Porrero E, Kouidi E, Lamotte M, Neunhauserer D, Reibis R, Spruit MA, Stettler C, Takken T, Tonoli C, Vigorito C, Voller H, Doherty P. The European Association of Preventive Cardiology Exercise Prescription in Everyday Practice and Rehabilitative Training (EXPERT) tool: A digital training and decision support system for optimized exercise prescription in cardiovascular disease. Concept, definitions and construction methodology. Eur J Prev Cardiol. 2017 Jul;24(10):1017-1031. doi: 10.1177/2047487317702042. Epub 2017 Apr 18.
citation: Zelko A, Bukova A, Kolarcik P, Bakalar P, Majercak I, Potocnikova J, Reijneveld SA, van Dijk JP. A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study. BMC Public Health. 2018 Apr 4;18(1):454. doi: 10.1186/s12889-018-5349-1.