Dataset Information

Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol.

ABSTRACT: Objective: Exercise interventions are underutilized in children with congenital heart disease (CHD) especially when the primary outcome is not peak oxygen uptake. Most of the studies are restricted to a low sample size and proximity of the patients to the study centers. Now eHealth approaches bear a promising but also challenging opportunity to transmit such intervention programs to participants, and check progress and compliance from remote. This study will aim to improve health-related physical fitness (HRPF) with a 24 weeks web-based exercise intervention. Methods and Design: The current study is planned as a randomized control trial (RCT) with a crossover design and the aim to improve functional outcome measures. It also estimates adherence and feasibility in patients with CHD in this web-based exercise/motor intervention over 24 weeks. Primary outcome will be the improvement of HRPF. Secondary outcomes are, functional and structural arterial stiffness measures and health-related quality of life. Thus, 70 children from 10 to 18 years with CHD of moderate and complex severity will be recruited and allocated randomly 1:1 in two study arms after baseline testing for their HRPF, arterial stiffness measures and health-related quality of life. For 24 weeks, participants in the intervention arm will receive three weekly exercise video clips of 20 min each. Every video clip comprises 20 child-oriented exercises which have to be executed for 30 s followed by a recovery period of 30 s. Each session will start with 3-4 warming-up exercises, followed by 10-12 strength and flexibility exercises, and ending with 3-4 min of cool down or stretching tasks. Continuous video clips will be streamed from a web-based e-Learning platform. The participant simply has to imitate the execution and follow some short advices. After each session, a brief online survey will be conducted to assess perceived exertion and feasibility. Discussion: The study will help to determine the efficacy and applicability of a web-based exercise intervention in children with CHD in regard to functional outcome measures. In addition, it will outline the effectiveness of remote monitoring, which provides a cost effective approach to reach patients with CHD that are low in prevalence and often do not live in close proximity to their tertiary center. Trial Registration: https://ClinicalTrials.gov Identifier: NCT03488797.

SUBMITTER: Meyer M

PROVIDER: S-EPMC6120348 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol.

Meyer Michael M Hreinsdottir Adalheidur A Häcker Anna-Luisa AL Brudy Leon L Oberhoffer Renate R Ewert Peter P Müller Jan J

Frontiers in pediatrics 20180827

<b>Objective:</b> Exercise interventions are underutilized in children with congenital heart disease (CHD) especially when the primary outcome is not peak oxygen uptake. Most of the studies are restricted to a low sample size and proximity of the patients to the study centers. Now eHealth approaches bear a promising but also challenging opportunity to transmit such intervention programs to participants, and check progress and compliance from remote. This study will aim to improve health-related ...[more]

PMID: 30211141

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Project description:Children with congenital heart disease (CHD) are often restricted from some types of physical activity (PA) despite the lack of evidence regarding the need to restrict recreational PA, apart from those with rhythm disorders. This study retrospectively investigated the associations between parent-reported activity restrictions (on-going need to restrict exertion, body contact or competition) and measures of health-related fitness among 236 children (8.2 ± 2.1 years, range 4−12 years) treated for single ventricle (n = 104), tetralogy of Fallot (n = 48), transposition of the great arteries (n = 47) or atrial septal defect (n = 37). Body mass index (BMI), moderate-to-vigorous physical activity (MVPA; 7 day accelerometry), strength, flexibility, and movement skill assessment results were collected from the baseline assessment research records for two studies completed in Ontario, Canada. A subset of 62 children also had physician-reported activity restrictions. Regression models empirically tested the goodness of fit between the dependent and independent variables. Participants with body contact restrictions from both parents and physicians had significantly higher BMI z-scores (0.23 ± 1.19 vs. −0.32 ± 0.85; t = 2.55; p = 0.04 and 0.66 ± 1.33 vs. −0.02 ± 0.98; t = 2.25; p = 0.02 for CDC and WHO scores, respectively). Otherwise, BMI z-score was not associated with patient variables (p > 0.36; sex, cardiac diagnosis, age, or activity restriction). Children with any type of parent-reported restriction (0.98 ± 2.06 vs. −0.08 ± 1.99; t = 3.77; p = 0.0002) were less flexible. Movement skill (TGMD-2) scores were 50% lower (25.1 ± 31.2 vs. 52.6 ± 28.6; F = 6.93; p = 0.009) among children with parent-reported competitive sport restrictions. Weekly MVPA (p > 0.18) and strength (p > 0.05) were not associated with activity restriction. Children whose parents reported PA restrictions were less flexible, and had decreased movement skill and increased BMI z-scores if the restrictions impacted competitive sport or body contact, respectively. Future research is recommended to confirm these results among larger samples of children who have both parent- and physician-specified PA restrictions.

Project description:BackgroundChildren with congenital heart disease (CHD) undergoing open-heart surgery are at risk for developmental impairments with motor delay manifesting first and contributing to parental concerns. Only a few interventional studies aim to improve neuromotor development in infants with CHD with inconclusive results. We thus developed a family-tailored early motor intervention (EMI-Heart), which aims to promote motor development and family well-being in the first year of life after open-heart surgery. The primary aim described in this protocol is to evaluate feasibility of EMI-Heart. The secondary aim is to describe the difference between the intervention and control group in motor outcomes and family well-being at baseline, post-treatment, and follow-up.MethodsThis prospective, parallel single-center feasibility randomized controlled trial (RCT) will compare EMI-Heart with standard of care in infants with complex CHD. Sixteen infants and their families, randomly allocated to EMI-Heart or the control group, will participate within the first 5 months of life. Infants assigned to EMI-Heart will receive early motor intervention for 3 months. The intervention's key is to promote infants' postural control to enhance motor development and partnering with parents to encourage family well-being. Feasibility outcomes will be (a) clinical recruitment rate and percentage of families completing EMI-Heart, (b) average duration and number of sessions, and (c) acceptability of EMI-Heart using a parental questionnaire post-treatment, and descriptive acceptability of EMI-Heart to the pediatric physiotherapist. Secondary outcomes of the intervention and control group will be infants' motor outcomes and questionnaires assessing family well-being at 3-5 months (baseline), at 6-8 months (post-treatment), and at 12 months of age (follow-up). We will evaluate feasibility using descriptive statistics. Non-parametric statistical analysis of secondary outcomes will assess differences between the groups at baseline, post-treatment, and follow-up.DiscussionThis feasibility RCT will provide information about a newly developed family-tailored early motor intervention in infants with complex CHD. The RCT design will provide a foundation for a future large-scale interventional trial for infants with CHD after open-heart surgery.Trial registrationThis study protocol (version 1.3, 01.02.2022) was approved by the Cantonal Ethics Commission Zurich (BASEC-Nr. 2019-01,787) and is registered by Clinicaltrials.gov (NCTT04666857).

Project description:BackgroundLatino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men.ObjectiveTo address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables.MethodsLatino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization.ResultsThis study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing.ConclusionsWe developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message-based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial.Trial registrationClinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570.International registered report identifier (irrid)DERR1-10.2196/23690.

Project description:BACKGROUND:Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children. The aim of the present study was to evaluate the effectiveness of an intensive oral health care program among children with CHD followed from infancy to the age of 5 years, by comparing their oral health status at 5 years with a control group of children with CHD who had not received the program. METHODS:In this longitudinal study, children in western Norway with a need for lifelong follow-up due to congenital heart defects were invited to participate (n?=?119). Children born in 2008-2011 were offered an oral health intervention program from infancy to the age of 5 years. The outcome measures for evaluating the intervention were dental caries prevalence, dental erosion, plaque index and gingival bleeding index. The data of the intervention group were compared with cross sectional oral health data of 5 year old controls with CHD born 2005-2007 (already published). RESULTS:Early oral health intervention did not affect the prevalence of caries (25.3% versus 25.4%) or dental erosion (22.2% versus 19.7%) of children with CHD assessed at 5 years. Children in the intervention group were less likely than those in the control group to present with both dental plaque and gingival bleeding at age 5 years. In spite of no difference in caries prevalence between the groups, caries affected children (d1-5mft) in the intervention group had fewer teeth affected by caries than children in the control group (p?=?0.06). The care index was reported to be higher in the intervention group compared with the control group, implying that fewer children in the intervention group suffered from untreated dentine caries. Parents in the intervention group were more likely to brush their children's teeth twice a day than parents of children in the control group. CONCLUSION:The oral health promotive program did not influence the prevalence of caries nor dental erosion. However, the findings indicated better oral hygiene, reduced gingival bleeding and less untreated dentine caries in the intervention compared with the control group. TRIAL REGISTRATION:ClinicalTrials.gov NCT03311438 . Registration date: October 17th 2017, retrospectively registered.

Dataset Information

Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol.

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Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol.

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