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Trial record 3 of 1565 for:    Slovakia

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

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ClinicalTrials.gov Identifier: NCT03329053
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
University of Groningen
Information provided by (Responsible Party):
Aurel Zelko, Pavol Jozef Safarik University

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: The EAPC Exercise Prescription (EXPERT) Tool Behavioral: Standard Cardio-Care Lifestyle Counselling Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in exercise recommendations compliance at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    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).


Secondary Outcome Measures :
  1. Change in body weight at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    Assessment of body weight with use of calibrated electronic scale (weight in kilograms).

  2. Change in body height at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    Assessment of body height with use of stadiometer (height in centimetres).

  3. Change in Body Mass Index at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    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.

  4. Change in leisure time physical activities at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    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).

  5. Change in clinical data at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    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.

  6. Change in health literacy at three months [ Time Frame: Before the intervention and 1-5 days after three months follow up ]
    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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329053


Contacts
Contact: Aurel Zelko, PhD. +421 (0) 055 234 1627 aurel.zelko@upjs.sk
Contact: Peter Bakalar, PhD. +421 (0) 055 234 1629 peter.bakalar@upjs.sk

Locations
Slovakia
Cardiology and Internal Medicine Ambulance Recruiting
Košice, Slovakia, 04001
Contact: Majerčák Ivan, MD    +421 (0) 55 7293 933    imajer@upjs.sk   
Contact: Aurel Zelko, PhD.         
Sponsors and Collaborators
Pavol Jozef Safarik University
University of Groningen
Investigators
Study Chair: Alena Bukova, PhD. Institute of Physical Education and Sport, Pavol Jozef Safarik University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aurel Zelko, Institute of Physical Education and Sport, Pavol Jozef Safarik University
ClinicalTrials.gov Identifier: NCT03329053     History of Changes
Other Study ID Numbers: PJSU-1/0825/17
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aurel Zelko, Pavol Jozef Safarik University:
exercise prescription
digital exercise prescription tool

Additional relevant MeSH terms:
Cardiovascular Diseases