Cardiovascular rehabilitation (CR) is an effective secondary preventive model of care. However, the use of CR is insufficient, and the reasons for this are not well-characterized in East-Central Europe. This prospective observational study psychometrically validated the recently translated Cardiac Rehabilitation Barriers Scale for the Czech language (CRBS-CZE) and identified the main CR barriers. Consecutive cardiac in/out-patients were approached from January 2020 for 18 months, of whom 186 (89.9%) consented. In addition to sociodemographic characteristics, participants completed the 21-item CRBS-CZE (response options 1–5, with higher scores representing greater barriers), and their CR utilization was tracked. Forty-five (24.2%) participants enrolled in CR, of whom 42 completed the CRBS a second time thereafter. Factor analysis revealed four factors, consistent with other CRBS translations. Internal reliability was acceptable for all but one factor (Cronbach’s alpha range = 0.44–0.77). Mean total barrier scores were significantly higher in non-enrollers (p < 0.001), decreased from first and second administration in these enrollers (p < 0.001), and were lower in CR completers (p < 0.001), supporting criterion validity. There were also significant differences in barrier scores by education, geography, tobacco use, among other variables, further supporting validity. The biggest barriers to enrolment were distance, work responsibilities, lack of time, transportation problems, and comorbidities; and the greatest barriers to adherence were distance and travel. Several items were considered irrelevant at first and second administration. Other barriers included wearing a mask during the COVID-19 pandemic. The study demonstrated sufficient validity and reliability of CRBS-CZE, which supports its use in future research.
Background: Cardiovascular diseases are highly prevalent and represent leading causes of morbidity worldwide, including in Central Europe. Cardiac rehabilitation (CR) is an effective method of secondary prevention, but utilization is low. Barriers to CR use in the Czech Republic are not well-characterized, and therefore we propose a protocol to translate and validate the cardiac rehabilitation barriers scale (CRBS). Methods: In this multi-method study, we translated and cross-culturally validated the CRBS to Czech (CRBS-CZE) first through the following main steps: professional translation, reconciliation/harmonization, and cross-cultural adaptation, and piloting in 50 cardiac patients. A prospective study will be undertaken to psychometrically-validate the CRBS-CZE, where 300 to 600 cardiac inpatients eligible for phase II/outpatient CR will be recruited. Consenting participants will be informed about the CR program and their sociodemographic, clinical characteristics, and the CRBS-CZE administered. Factor analysis will be performed with oblique rotation, factors will be extracted based on eigenvalues, the examination of the scree plot, and factor loadings. The internal reliability of the total scale and subscales will be assessed with Cronbach alpha. Overall CRBS scores will be compared by patient characteristics such as sex, socioeconomic indicators, risk factor burden, and travel time to investigate content validity. Their CR enrollment, adherence (% of 24 prescribed sessions attended), and completion will be tracked. The second administration of CRBS-CZE will be undertaken in patients at 3 weeks after enrollment. To test criterion validity, t tests and Pearson correlation (for adherence) will be used to determine the association of these utilization indicators with CRBS scores. Results: The translated version was considered by 2 bilingual CR experts. Some revisions and example additions were made to the items. Upon piloting with patients, some further edits were made. No additional barriers were raised. Discussion: Through this study, a reliable and valid means of assessing patient's CR barriers will be established. Results will be used to identify ways to help patients overcome barriers to CR utilization.
Introduction: Cardiovascular diseases are the world's most common causes of morbidity and mortality in the population, including Central Europe. Cardiac rehabilitation (CR) is an effective preventive approach that includes several core components. Physical training is identified as an integral and essential part of CR. Training can positively influence several cardiovascular risk factors in people diagnosed with coronary heart disease and prevent them from clinical events. Our study aims to research the method of high-intensity interval training (HIIT) in a home environment using telerehabilitation. We assume that the HIIT form of telerehabilitation, using a heart rate monitor as a tool for backing up training data, can improve cardiorespiratory fitness and lead to higher peak oxygen uptake than the traditional moderate-intensity continuous training (MICT). Methods: This study is designed as a monocentral randomized controlled trial at University Hospital Brno in the Czech Republic. After the coronary heart event, the suitable patients will be randomized (1:1 ratio) and separated into 2 groups: the experimental HIIT group and the control MICT group. Both groups undergo a 12-week telerehabilitation with a 1-year follow-up period. Study participants will be telemonitored during physical training in their home environment via a heart rate monitor and a web platform. Once a week, the patients will give their feedback and motivation by a telephone call. The primary outcome observed will be the effect of intervention expressed by changes in cardiorespiratory fitness. Secondary outcomes will be the health-related quality of life, anxiety, training adherence, body composition, safety, and satisfaction. Discussion: The HIIT is widely researched predominantly in a center-based supervised form. Our study differs from others by the use of telemedicine and smart technologies in home-based settings. Previous home-based cardiac telerehabilitation studies have focused primarily on MICT, which has demonstrated feasibility, and results have shown similar improvements as center-based CR. There is a presumption that HIIT may be superior to MICT. However, it can be complicated to self-dose the method in the home environment. Investigators expect that HIIT research will provide insight into the possibilities of telemedicine feasibility, effect, and limitations of coronary heart disease patients’ use at low to moderate cardiovascular risk.
Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): the Ministry of Health, Czech Republic - conceptual development of research organization (65269705) Background Cardiovascular diseases are leading causes of morbidity and mortality worldwide, including in Central Europe. Cardiac rehabilitation (CR) represents an efficient secondary prevention model, but it is highly underutilised. Barriers to CR in the Czech Republic (and in Central Europe) are not well-characterised, and therefore we present a study to define these barriers. Purpose Through this study, a reliable and valid means of assessing patient"s CR barriers will be established. Results will be used to identify ways to help patients overcome barriers to CR and potentially contribute to improving CR utilisation in this region. Methods This is a multi-method study. First, in 2019, we professionally translated and cross-culturally validated the Cardiac Rehabilitation Barriers Scale to Czech (CRBS-CZE), and piloting it in 50 cardiac patients. A prospective study was undertaken to psychometrically-validate the CRBS-CZE, where patients eligible for phase II/outpatient CR were recruited. The internal reliability of the scale was assessed with Cronbach"s alpha. In total, 143 eligible patients (target of 200-300 patients) in the University Hospital Brno was approached from January 2020 for one year. Consenting participants were informed about the CR program and their sociodemographic (age, sex, highest educational attainment, work status, travel time), clinical characteristics (diagnosis, anthropometrics, blood pressure, lipids levels, diabetes), heart-healthy behaviours (level of physical activity, tobacco use, harmful use of alcohol), and the CRBS-CZE administered. Mean CRBS-CZE scores (21-items/barriers, five-point Likert scale) were analysed to determine key barriers in this setting. To test construct validity, differences in CRBS-CZE total scores were compared by patient characteristics outlined above, using a t-test and Pearson"s correlation. Patient"s enrollment, adherence, and completion of the CR program (% of 24 prescribed sessions attended) were tracked. Results (preliminary) The CRBS-CZE had good internal consistency (Cronbach’s alpha = .74). Mean total perceived barriers were significantly greater among non-enrollers (2.1, SD = .57) than CR enrollers (1.8, SD = .53), and among rural (2.2, SD = .54) than urban inhabitants (1.7, SD = .46) (p < .05). The long distance from CR facilities (mean commuting time about 50 mins), a little free time, and the transportation problems were identified as the greatest barriers. From all eligible patients, 19.6% entered and 10.5% completed the CR program. The mean completion rate was 70.6%. The main limitations of the study were a small number of participants and the COVID-19 pandemic. Conclusion The CRBS-CZE has shown adequate validity and reliability, which supports its use in future studies. Results also point to suboptimal CR availability in the Czech Republic. This finding, especially in the pandemic situation, promotes the need for CR alternatives like home-based programs and telerehabilitation.
Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Ministry of Health Czech Republic; identification of organization 65269705 Background Although continuous positive airway pressure (CPAP) is currently still the gold standard for therapy of moderate to severe obstructive sleep apnea (OSA), another alternative or adjunct effective therapeutic options exist. Lifestyle intervention focused on nutrition and weight reduction, regular exercise, sleep hygiene, smoking and alcohol restriction represents a recommended therapeutic strategy for OSA. Though this intervention represents an effective tool for improving objective and subjective parameters of OSA, it’s effectivity depends on components of the intervention, OSA severity and gender. Comprehensive remotely-supervised cardiac rehabilitation (CR) represents possible training intervention in home conditions using elements of telemedicine. Purpose This prospective study aims to investigate the feasibility and effect of a remotely-supervised CR in patients with newly diagnosed OSA with Apnea-Hypopnea Index greater than 15 episodes per hour. Methods This monocentric study is designed as a prospective, parallel, randomised, controlled trial of remotely-supervised 12-week CR in male patients between 40-60 years old with newly diagnosed OSA indicated to CPAP therapy. The sample size is calculated by 0,05 level of significance and 80% statistical power on 25 participants in each group. The Intervention group will undergo comprehensive remotely-supervised CR in home conditions with teleconsultation (contains telecoaching, telemonitoring) via regular phone calls and e-mails at least 1-2 times a week. The intervention will include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy. The control group will undergo individually titrated CPAP therapy only. The participants in both groups will go through the following assessments before and after this study: polysomnography, spirometry, anthropometry and body composition examination, laboratory values examination, quality of life questionnaires, Epworth sleepiness scale, 6-min walking test. Conclusions: Comprehensive remotely-supervised CR, as mentioned in this study, may represent an adjunct therapy with a promising future in patients with OSA. The study is occupied with a current issue and can also bring new possibilities and experiences in remote rehabilitation.
Background Obstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy. Objective This study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters. Methods This randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization’s tool to measure QoL (WHOQOL-BREF) score; and lipid profile values. Results Study recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone. Conclusions The study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA. Trial Registration ClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456 International Registered Report Identifier (IRRID) DERR1-10.2196/47460
BACKGROUND Obstructive sleep apnea (OSA) is characterized by recurrent intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the quality of the patient's daily life (QoL). Middle-aged and older men who smoke and suffer from obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the standard treatment, various rehabilitation methods also appear to be effective. OBJECTIVE This study aims to evaluate if comprehensive home-based remotely supervised rehabilitation program (tele-RHB program) in combination with standard therapy improves severity, objectives parameters and subjective perception in male participants with OSA. METHODS This randomized controlled trial aims to recruit 50 male participants between the ages of 30-60 years with newly diagnosed OSA. Participants will be randomized 1:1 either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a One year follow-up. The primary outcomes will be the apnea-hypopnea index, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey score, percentage of body fat, six minute walk test distance covered, and maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include values of other selected polysomnographic parameters, anthropometric measurements of neck, waist, hip circumference and body mass index values, forced vital capacity, and forced expiratory volume in 1 second, WHOQOL - BREF score and lipid profile values. RESULTS Study recruitment began on October 25, 2021, and estimated study completion is expected on December 2024. Analyses will be performed to examine whether the combination of tele-RHB program and CPAP therapy will be more effective in reduction of OSA severity, improvement of QoL, body composition, and circumferences, exercise tolerance, lipid profile, and respiratory muscle and lung function compared to CPAP therapy alone. CONCLUSIONS The study will evaluate the effect of comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based option for OSA. CLINICALTRIAL ClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456
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