An interventional study of The EAPC Exercise Prescription (EXPERT) Tool and Standard Cardio-Care Lifestyle Counselling in Cardiovascular Diseases, sponsored by Pavol Jozef Safarik University. Withdrawn at 1 site in Slovakia. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-17.
Sponsored by Pavol Jozef Safarik University · Not applicable, Interventional, and Prevention
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
Browse Cardiovascular Diseases studies →Pavol Jozef Safarik University is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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, 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.
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.
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).
Time frame: Before the intervention and 1-5 days after three months follow up
Change in body weight at three months
Assessment of body weight with use of calibrated electronic scale (weight in kilograms).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Before the intervention and 1-5 days after three months follow up
Plan to share: No
Ran from Feb 2018 to primary completion in Feb 2020, 24 months.
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Pavol Jozef Safarik University