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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: The EAPC Exercise Prescription (EXPERT) Tool; Behavioral: Standard Cardio-Care Lifestyle Counselling

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Košice, Slovakia, 04001
    • Cardiology and Internal Medicine Ambulance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise recommendations compliance at three months	Compliance will be determined as agreement between indices of exercise prescription delivered by EXPERT tool and self-reported indices of exercise performed in monitoring periods (1 year and 7 days period).	Before the intervention and 1-5 days after three months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight at three months	Assessment of body weight with use of calibrated electronic scale (weight in kilograms).	Before the intervention and 1-5 days after three months follow up
Change in body height at three months	Assessment of body height with use of stadiometer (height in centimetres).	Before the intervention and 1-5 days after three months follow up
Change in Body Mass Index at three months	Calculation of Body Mass Index based on patient's body weight and body height (in meters). Body Mass Index will be calculated as body weight in kilograms divided by body height in meters squared.	Before the intervention and 1-5 days after three months follow up
Change in leisure time physical activities at three months	To measure the prevalence of physical activities unqualified as sport-related or performance-oriented exercises we will measure leisure time behaviours of participants via International Physical Activity Questionnaire - Short Form (IPAQ-SF).	Before the intervention and 1-5 days after three months follow up
Change in clinical data at three months	Clinical data will included a list of actual patient's cardiovascular disease, cardiovascular risk factors, other chronic non-cardiovascular co-morbidities, patient´s medication (type of medication), systolic and diastolic blood pressure (mmHg), blood total and low-density lipoprotein cholesterol concentration (mmol/l), fasting glycaemia (mmol/l), resting, and known patient´s adverse events registered during exercise testing.	Before the intervention and 1-5 days after three months follow up
Change in health literacy at three months	The Health literacy level will be assessed using The Health Literacy Questionnaire (HLQ). This questionnaire comprises nine domains to provide a detailed profile of health literacy of populations, groups or patients of interest. The HLQ is divided into two parts which differ in response categories. Part 1 (domains 1-5) has 4 response categories rating the extent of agreement from 1 to 4. Part 2 (domains 6-9) has 5 response categories rating the level of difficulty from cannot do or always difficult (1), to always easy (5). Each domain was scored as the average of the item scores. The score ranges from 1 to 4 or 1 to 5 respectively, a higher score indicating higher level of health literacy.	Before the intervention and 1-5 days after three months follow up

Collaborators and Investigators

• Sponsor: Pavol Jozef Safarik University
• Collaborators: University of Groningen
• Investigators: Study Chair: Alena Bukova, PhD., Institute of Physical Education and Sport, Pavol Jozef Safarik University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): February 23, 2020
• Study Completion (Anticipated): February 23, 2020

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: exercise prescription; digital exercise prescription tool
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PJSU-1/0825/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No