BACKGROUND: Physical activity is pivotal in managing heart failure with reduced ejection fraction, and walking integrated into daily life is an especially suitable form of physical activity. This study aimed to determine whether a 6-month lifestyle walking intervention combining self-monitoring and regular telephone counseling improves functional capacity assessed by the 6-minute walk test (6MWT) in patients with stable heart failure with reduced ejection fraction compared with usual care. METHODS: The WATCHFUL trial (Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction) was a 6-month multicenter, parallel-group randomized controlled trial recruiting patients with heart failure with reduced ejection fraction from 6 cardiovascular centers in the Czech Republic. Eligible participants were ≥18 years of age, had left ventricular ejection fraction <40%, and had New York Heart Association class II or III symptoms on guidelines-recommended medication. Individuals exceeding 450 meters on the baseline 6MWT were excluded. Patients in the intervention group were equipped with a Garmin vívofit activity tracker and received monthly telephone counseling from research nurses who encouraged them to use behavior change techniques such as self-monitoring, goal-setting, and action planning to increase their daily step count. The patients in the control group continued usual care. The primary outcome was the between-group difference in the distance walked during the 6MWT at 6 months. Secondary outcomes included daily step count and minutes of moderate to vigorous physical activity as measured by the hip-worn Actigraph wGT3X-BT accelerometer, NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity C-reactive protein biomarkers, ejection fraction, anthropometric measures, depression score, self-efficacy, quality of life, and survival risk score. The primary analysis was conducted by intention to treat. RESULTS: Of 218 screened patients, 202 were randomized (mean age, 65 years; 22.8% female; 90.6% New York Heart Association class II; median left ventricular ejection fraction, 32.5%; median 6MWT, 385 meters; average 5071 steps/day; average 10.9 minutes of moderate to vigorous physical activity per day). At 6 months, no between-group differences were detected in the 6MWT (mean 7.4 meters [95% CI, -8.0 to 22.7]; P=0.345, n=186). The intervention group increased their average daily step count by 1420 (95% CI, 749 to 2091) and daily minutes of moderate to vigorous physical activity by 8.2 (95% CI, 3.0 to 13.3) over the control group. No between-group differences were detected for any other secondary outcomes. CONCLUSIONS: Whereas the lifestyle intervention in patients with heart failure with reduced ejection fraction improved daily steps by about 25%, it failed to demonstrate a corresponding improvement in functional capacity. Further research is needed to understand the lack of association between increased physical activity and functional outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03041610.

• Klíčová slova
• behavior, cardiac rehabilitation, counseling, exercise, fitness trackers, walk test, walking,
• MeSH
• chůze MeSH
• dysfunkce levé srdeční komory * MeSH
• funkce levé komory srdeční MeSH
• kvalita života MeSH
• lidé MeSH
• senioři MeSH
• srdeční selhání * terapie   farmakoterapie   MeSH
• tepový objem MeSH
• životní styl MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients' compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. OBJECTIVES: The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. METHODS: The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. DISCUSSION: The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients' recruitment and impacted their physical activity patterns. CONCLUSIONS: The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).

• Klíčová slova
• Functional capacity, Garmin, Intention-to-treat analysis, Phone counseling, Physical activity, Pragmatic trial, Self-monitoring, Six-minute walk test, Tele-rehabilitation, Wearables,
• MeSH
• aktigrafie MeSH
• chůze MeSH
• COVID-19 * MeSH
• lidé MeSH
• pandemie MeSH
• srdeční selhání * diagnóza   terapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

AIMS: Accelerometers are becoming increasingly commonplace for assessing physical activity; however, their use in patients with cardiovascular diseases is relatively substandard. We aimed to systematically review the methods used for collecting and processing accelerometer data in cardiology, using the example of heart failure, and to provide practical recommendations on how to improve objective physical activity assessment in patients with cardiovascular diseases by using accelerometers. METHODS AND RESULTS: Four electronic databases were searched up to September 2019 for observational, interventional, and validation studies using accelerometers to assess physical activity in patients with heart failure. Study and population characteristics, details of accelerometry data collection and processing, and description of physical activity metrics were extracted from the eligible studies and synthesized. To assess the quality and completeness of accelerometer reporting, the studies were scored using 12 items on data collection and processing, such as the placement of accelerometer, days of data collected, and criteria for non-wear of the accelerometer. In 60 eligible studies with 3500 patients (of those, 536 were heart failure with preserved ejection fraction patients), a wide variety of accelerometer brands (n = 27) and models (n = 46) were used, with Actigraph being the most frequent (n = 12), followed by Fitbit (n = 5). The accelerometer was usually worn on the hip (n = 32), and the most prevalent wear period was 7 days (n = 22). The median wear time required for a valid day was 600 min, and between two and five valid days was required for a patient to be included in the analysis. The most common measures of physical activity were steps (n = 20), activity counts (n = 15), and time spent in moderate-to-vigorous physical activity (n = 14). Only three studies validated accelerometers in a heart failure population, showing that their accuracy deteriorates at slower speeds. Studies failed to report between one and six (median 4) of the 12 scored items, with non-wear time criteria and valid day definition being the most underreported items. CONCLUSIONS: The use of accelerometers in cardiology lacks consistency and reporting on data collection, and processing methods need to be improved. Furthermore, calculating metrics based on raw acceleration and machine learning techniques is lacking, opening the opportunity for future exploration. Therefore, we encourage researchers and clinicians to improve the quality and transparency of data collection and processing by following our proposed practical recommendations for using accelerometers in patients with cardiovascular diseases, which are outlined in the article.

• Klíčová slova
• Counts, Cut points, Heart failure, Physical activity, Raw acceleration, Steps,
• MeSH
• akcelerometrie MeSH
• cvičení MeSH
• kardiovaskulární nemoci * MeSH
• lidé MeSH
• srdeční selhání * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• systematický přehled MeSH

AIMS: A reduction of habitual physical activity due to prolonged COVID-19 quarantine can have serious consequences for patients with cardiovascular diseases, such as heart failure. This study aimed to explore the effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients. METHODS AND RESULTS: We analysed the daily number of steps in 26 heart failure patients during a 6-week period that included 3 weeks immediately preceding the onset of the quarantine and the first 3 weeks of the quarantine. The daily number of steps was assessed using a wrist-worn accelerometer worn by the patients as part of an ongoing randomized controlled trial. Multilevel modelling was used to explore the effect of the quarantine on the daily step count adjusted for weather conditions. As compared with the 3 weeks before the onset of the quarantine, the step count was significantly lower during each of the first 3 weeks of the quarantine (P < 0.05). When the daily step count was averaged across the 3 weeks before and during the quarantine, the decrease amounted to 1134 (SE 189) steps per day (P < 0.001), which translated to a 16.2% decrease. CONCLUSIONS: The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period. Staying active and maintaining sufficient levels of physical activity during the COVID-19 pandemic are essential despite the unfavourable circumstances of quarantine.

• Klíčová slova
• Accelerometer, COVID-19, Heart failure, Lockdown, Physical activity, Quarantine,
• MeSH
• akcelerometrie metody   MeSH
• časové faktory MeSH
• COVID-19 MeSH
• cvičení fyziologie   MeSH
• dospělí MeSH
• hodnocení rizik MeSH
• karanténa * MeSH
• kohortové studie MeSH
• koronavirové infekce epidemiologie   prevence a kontrola   MeSH
• lidé středního věku MeSH
• lidé MeSH
• pandemie prevence a kontrola   statistika a číselné údaje   MeSH
• prognóza MeSH
• retrospektivní studie MeSH
• senioři MeSH
• srdeční selhání patofyziologie   rehabilitace   MeSH
• tělesná výkonnost fyziologie   MeSH
• test chůzí statistika a číselné údaje   MeSH
• virová pneumonie epidemiologie   prevence a kontrola   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH

INTRODUCTION: Although numerous activity trackers have been validated in healthy populations, validation is lacking in chronic heart failure patients who normally walk at a slower pace, making it difficult for researchers and clinicians to implement activity monitors during physical activity interventions. METHODS: Six consumer-level activity monitors were validated in a 3-day field study in patients with chronic heart failure and healthy individuals under free living conditions. Furthermore, the same devices were evaluated in a lab-based study during treadmill walking at speeds of 2.4, 3.0, 3.6, and 4.2 km·h-1. Concordance correlation coefficients (CCC) were used to evaluate the agreement between the activity monitors and the criterion, and mean absolute percentage errors (MAPE) were calculated to assess differences between each device and the criterion (MAPE <10% was considered as a threshold for validity). RESULTS: In the field study of healthy individuals, all but one of the activity monitors showed a substantial correlation (CCC ≥0.95) with the criterion device and MAPE <10%. In patients with heart failure, the correlation of only two activity monitors (Garmin vívofit 3 and Withings Go) was classified as at least moderate (CCC ≥0.90) and none of the devices had MAPE <10%. In the lab-based study at speeds 4.2 and 3.6 km·h-1, all activity monitors showed substantial to almost perfect correlations (CCC ≥0.95) with the criterion and MAPE in the range 1%-3%. However, at slower speeds of 3.0 and 2.4 km·h-1, the accuracy of all devices substantially deteriorated: their correlation with the criterion decreased below 90% and their MAPE increased to 4-8% and 10-45%, respectively. CONCLUSIONS: Even though none of the tested activity monitors fall within arbitrary thresholds for validity, most of them perform reasonably well enough to be useful tools that clinicians can use to simply motivate chronic heart failure patients to walk more.

• MeSH
• akcelerometrie přístrojové vybavení   metody   MeSH
• ambulantní monitorování přístrojové vybavení   metody   MeSH
• chronická nemoc MeSH
• chůze fyziologie   MeSH
• cvičení fyziologie   MeSH
• dospělí MeSH
• fitness náramky MeSH
• lidé MeSH
• reprodukovatelnost výsledků MeSH
• senioři MeSH
• srdeční selhání patofyziologie   MeSH
• zátěžový test přístrojové vybavení   metody   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

BACKGROUND: General practitioners play a fundamental role in combatting the current epidemic of physical inactivity, and pedometer-based walking interventions are able to increase physical activity levels of their patients. Supplementing these interventions with email counseling driven by feedback from the pedometer has the potential to further improve their effectiveness but it has to be yet confirmed in clinical trials. Therefore, the aim of our pilot randomized controlled trial is to evaluate the feasibility and potential efficacy of future trials designed to assess the additional benefit of email counseling added to a pedometer-based intervention in a primary care setting. METHODS: Physically inactive patients were opportunistically recruited from four general practices and randomized to a 12-week pedometer-based intervention with or without email counseling. To explore the feasibility of future trials, we assessed the speed and efficiency of recruitment, adherence to wearing the pedometer, and engagement with email counseling. To evaluate the potential efficacy, daily step-count was the primary outcome and blood pressure, waist and hip circumference, and body mass were the secondary outcomes. Additionally, we conducted a qualitative analysis of structured interviews with the participating general practitioners. RESULTS: The opportunistic recruitment has been shown to be feasible and acceptable, but relatively slow and inefficient; moreover, general practitioners selectively recruited overweight and obese patients. Patients manifested high adherence, wearing the pedometer on 83% (± 20) of days. All patients from the counseling group actively participated in email communication and responded to 46% (± 22) of the emails they received. Both groups significantly increased their daily step-count (pedometer-plus-email, + 2119, p = 0.002; pedometer-alone, + 1336, p = 0.03), but the difference between groups was not significant (p = 0.18). When analyzing both groups combined, there was a significant decrease in body mass (- 0.68 kg, p = 0.04), waist circumference (- 1.73 cm, p = 0.03), and systolic blood pressure (- 3.48 mmHg, p = 0.045). CONCLUSIONS: This study demonstrates that adding email counseling to a pedometer-based intervention in a primary care setting is feasible and might have the potential to increase the efficacy of such an intervention in increasing physical activity levels. TRIAL REGISTRATION: The trial was retrospectively registered at ClinicalTrials.gov (ID: NCT03135561 , date: April 26, 2017).

• Klíčová slova
• Adherence, Email counseling, General practitioner, Pedometer, Physical activity, Primary care, Qualitative research, Recruitment, Walking,
• MeSH
• aktigrafie přístrojové vybavení   MeSH
• chůze fyziologie   MeSH
• dospělí MeSH
• elektronická pošta statistika a číselné údaje   MeSH
• hodnocení programu MeSH
• lidé středního věku MeSH
• lidé MeSH
• pilotní projekty MeSH
• podpora zdraví metody   MeSH
• poradenství statistika a číselné údaje   MeSH
• praktické lékařství * MeSH
• senioři MeSH
• studie proveditelnosti MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH