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

NCT03329053 | Withdrawn DMC

• 1 other identifier: PJSU-1/0825/17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

exercise prescription; digital exercise prescription tool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in body weight at three months

  Before the intervention and 1-5 days after three months follow up

• Change in body height at three months

  Before the intervention and 1-5 days after three months follow up

• Change in Body Mass Index at three months

  Before the intervention and 1-5 days after three months follow up

• Change in leisure time physical activities at three months

  Before the intervention and 1-5 days after three months follow up

• Change in clinical data at three months

  Before the intervention and 1-5 days after three months follow up

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

The EAPC Exercise Prescription (EXPERT) Tool BEHAVIORAL

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.

Experimental group

Standard Cardio-Care Lifestyle Counselling BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead
• University of Groningen: collaborator

Study Sites (1)

Cardiology and Internal Medicine Ambulance

Košice, 04001, Slovakia

Location

Related Publications (2)

• 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.

  PMID: 28420250 BACKGROUND

• 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.

  PMID: 29618329 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Equipment and Supplies

Study Officials

• Alena Bukova, PhD.

  Institute of Physical Education and Sport, Pavol Jozef Safarik University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute of Physical Education and Sport

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 1, 2017
• Study Start: February 23, 2018
• Primary Completion: February 23, 2020
• Study Completion: February 23, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)