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Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.

ABSTRACT: INTRODUCTION:Despite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based Expecting intervention (NCT02125149) with pregnant women with obesity in community settings. METHODS AND ANALYSIS:We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted Expecting intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol). ETHICS AND DISSEMINATION:This study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT04298125; Pre-results.

SUBMITTER: Swindle T

PROVIDER: S-EPMC7478046 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.

Swindle Taren T Martinez Audrey A Børsheim Elisabet E Andres Aline A

BMJ open 20200906 9

<h4>Introduction</h4>Despite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based <i>Expecting</i> intervent ...[more]

PMID: 32895286

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Project description:IntroductionOur aim was to evaluate a community-based exercise (CBE) intervention with the goal of reducing disability and enhancing health for community-dwelling people living with HIV (PLWH).Methods and analysisWe will use a mixed-methods implementation science study design, including a prospective longitudinal interrupted time series study, to evaluate a CBE intervention with PLWH in Toronto, Canada. We will recruit PLWH who consider themselves medically stable and safe to participate in exercise. In the baseline phase (0-8 months), participants will be monitored bimonthly. In the intervention phase (8-14 months), participants will take part in a 24-week CBE intervention that includes aerobic, resistance, balance and flexibility exercise at the YMCA 3 times per week, with weekly supervision by a fitness instructor, and monthly educational sessions. In the follow-up phase (14-22 months), participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. Quantitative assessment: We will assess cardiopulmonary fitness, strength, weight, body composition and flexibility outcomes followed by the administration of self-reported questionnaires to assess disability and contextual factor outcomes (coping, mastery, stigma, social support) bimonthly. We will use time series regression analysis to determine the level and trend of outcomes across each phase in relation to the intervention. Qualitative assessment: We will conduct a series of face-to-face interviews with a subsample of participants and recreation providers at initiation, midpoint and completion of the 24-week CBE intervention. We will explore experiences and anticipated benefits with exercise, perceived impact of CBE for PLWH and the strengths and challenges of implementing a CBE intervention. Interviews will be audio recorded and analysed thematically.Ethics and disseminationProtocol approved by the University of Toronto HIV/AIDS Research Ethics Board. Knowledge translation will occur with stakeholders in the form of presentations and publications in open access peer-reviewed journals.Trial registration numberNCT02794415; Pre-results.

Project description:BACKGROUND:Creating inclusive and accessible outdoor environments that provide and encourage opportunities for older adults to engage in physical activity and social interaction is important for healthy ageing. The Senior Exercise Park is outdoor exercise equipment designed specifically for use by older people that provides physical and social benefits for older people in the community, and has the potential to be used widely as a sustainable mode of physical activity. The aim of this study is to implement and evaluate the effects of sustained engagement through the use of a community-based novel outdoor physical activity program (purpose-built exercise park) for older people on physical, mental and social health and physical activity outcomes (the ENJOY project). METHODS:This is a prospective pre-post design study with 12 months follow up. Adults aged ≥60 years will be recruited from the general community from the suburbs close to the Senior Exercise Parks locations in Melbourne. Participants will undergo a 12 week structured supervised physical activity program using the outdoor Senior Exercise Park equipment followed by 6 months unstructured physical activity program. Participants will be assessed at baseline, 3, 9, and 12 months. The following outcomes will be assessed: physical activity, physical function, psychosocial and mental health outcomes, falls risk and falls occurrence, participants' feedback and satisfaction, and health care resource use. DISCUSSION:The ENJOY trial is designed to operate in a community setting with local government engagement to maximise the usage of the exercise park and provide an outdoor space for older people to be physically active. This project will evaluate the effectiveness and sustainability of the outdoor exercise park on a range of health outcomes and its long-term usability in the community. TRIAL REGISTRATION:This trial is prospectively registered with the Australian New Zealand Clinical Trials Registry. Trial registration number ACTRN12618001727235 registered 18th of October 2018.

Project description:IntroductionOur aim is to evaluate the implementation of an online telecoaching community-based exercise (CBE) intervention with the goal of reducing disability and enhancing physical activity and health among adults living with HIV.Methods and analysisWe will conduct a prospective longitudinal mixed-methods two-phased intervention study to pilot the implementation of an online CBE intervention with ~30 adults (≥18 years) living with HIV who consider themselves safe to participate in exercise. In the intervention phase (0-6 months), participants will take part in an online CBE intervention involving thrice weekly exercise (aerobic, resistance, balance and flexibility), with supervised biweekly personal training sessions with a fitness instructor, YMCA membership providing access to online exercise classes, wireless physical activity monitor to track physical activity and monthly online educational sessions on topics related to HIV, physical activity and health. In the follow-up phase (6-12 months), participants will be encouraged to continue independent exercise thrice weekly. Quantitative assessment: Bimonthly, we will assess cardiopulmonary fitness, strength, weight, body composition and flexibility, followed by administering self-reported questionnaires to assess disability, contextual factor outcomes (mastery, engagement in care, stigma, social support), implementation factors (cost, feasibility, technology), health status and self-reported physical activity. We will conduct a segmented regression analyses to describe the change in level and trend between the intervention and follow-up phases. Qualitative assessment: We will conduct online interviews with a subsample of ~10 participants and 5 CBE stakeholders at baseline (month 0), postintervention (month 6) and end of follow-up (month 12) to explore experiences, impact and implementation factors for online CBE. Interviews will be audiorecorded and analysed using content analytical techniques.Ethics and disseminationProtocol approved by the University of Toronto Research Ethics Board (Protocol # 40410). Knowledge translation will occur in the form of presentations and publications in open-access peer-reviewed journals.Trial registration numberNCT05006391.

Project description:IntroductionNovel therapies for pulmonary hypertension (PH) have improved survival and slowed disease progression. However, patients still present with symptoms of exertional dyspnoea and fatigue, which impacts their ability to perform activities of daily living, reduces exercise tolerance and impairs their quality of life (QoL). Exercise training has shown to be safe and effective at enhancing QoL and physical function in PH patients, yet it remains an underused adjunct therapy. Most exercise training for PH patients has been offered through hospital-based programmes. Home-based exercise programmes provide an alternative model that has the potential to increase the availability and accessibility of exercise training as an adjunct therapy in PH. The purpose of this study is to investigate the feasibility, acceptability, utility and safety of a novel remotely supervised home-based PH exercise programme.MethodsSingle arm intervention with a pre/post comparisons design and a follow-up maintenance phase will be employed. Eligible participants (n=25) will be recruited from the Mater Misericordiae University Hospital PH Unit. Participants will undergo a 10-week home-based exercise programme, with induction training, support materials, telecommunication support and health coaching sessions followed by a 10-week maintenance phase. The primary outcomes are feasibility, acceptability, utility and safety of the intervention. Secondary outcomes will include the impact of the intervention on exercise capacity, physical activity, strength, health-related QoL and exercise self-efficacy.Ethics and disseminationEthics approval has been obtained from the Mater Misericordiae Institutional Review Board REF:1/378/2032 and Dublin City University Research Ethics DCUREC/2018/246. A manuscript of the results will be submitted to a peer-reviewed journal and results will be presented at conferences, community and consumer forums and hospital research conferences.Trial registration numberISRCTN83783446; Pre-results.

Project description:BackgroundStress urinary incontinence (SUI) is a common source of distress among women during and after pregnancy. It has a negative effect on quality of life but with poor care-seeking. Mobile health (mHealth) may be a promising solution with potential advantages. However, there is uncertainty whether a mobile app is effective for SUI symptom improvement during and after pregnancy. The implementation is also unclear. We developed an app named UIW (Urinary Incontinence for Women) aimed at improving perinatal incontinence.ObjectiveThe objective of this study is to evaluate the effectiveness of the UIW app-based intervention in improving SUI symptoms among pregnant women and explore the facilitators and barriers to using the UIW app to help refine and optimize the intervention.MethodsThis study is a hybrid effectiveness-implementation trial with a randomized controlled trial alongside a mixed-methods process evaluation according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Pregnant women with SUI (n=336) will be recruited from a university-affiliated hospital in China. They will be randomly allocated (1:1) to either the intervention group that receive usual care plus UIW app or control group that receive usual care alone. The intervention period will last 2 months. The 5 dimensions of the RE-AIM framework will be evaluated at recruitment (-T1), baseline (T0), immediately after intervention (T1), 42 days after delivery (T2), 3 months after delivery (T3), and 6 months after delivery (T4) through project documents, online questionnaires and a pelvic floor muscle training diary, surface electromyography, log data in the background management system, and qualitative interviews. Data analysis will follow the intention-to-treat principle. Descriptive statistics, t tests, chi-square tests, and a linear mixed model will be used to analyze the quantitative data. Deductive and inductive content analysis will be used to analyze the qualitative data.ResultsThe effectiveness-implementation trial started in June 2020, trial recruitment was completed in October 2020, and the intervention will last for a 2-month period. Completion of the 6-month follow-up will be in July 2021, and we anticipate that the results of this study will be published in December 2021.ConclusionsThis study will evaluate both effectiveness and implementation of the UIW app-based intervention among pregnant women. The hybrid effectiveness-implementation trial design according to the RE-AIM framework with a mixed-methods approach will give valuable insights into the effects as well as facilitators and barriers to the implementation that will influence the effects of the UIW app-based intervention.Trial registrationChinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.International registered report identifier (irrid)PRR1-10.2196/22771.

Project description:Despite global awareness about the importance and health benefits of physical activity (PA) during pregnancy, several studies have reported a low prevalence of PA participation among pregnant women in both developed and developing countries. This means that most pregnant women do not meet the current PA recommended guideline of 150 min of moderate intensity PA per week. The global call to prioritise PA participation levels in the general population necessitates evaluating the factors affecting PA practice. Seemingly, pregnant women mostly from low-to-middle income countries like South Africa are often predisposed to adverse pregnancy outcomes, possibly because of limited access to, and knowledge of, improved pregnancy and health outcomes as a result of PA participation. Physical activity has been sparsely studied among pregnant South African women, and specifically, there is no known study that assesses the PA levels, patterns, beliefs, sources of information, perceived benefits, barriers, attitudes of pregnant women concerning PA and exercise participation; nor one that explores the perspectives of healthcare providers regarding prenatal PA in the Eastern Cape Province. In addition, no PA intervention strategy exists to promote PA participation in the region. This study, in attempting to fill these gaps in knowledge, adopts two phases. In Phase I, a concurrent mixed-method (quantitative and qualitative) approach assesses the following factors related to PA participation in pregnant women: participation levels, beliefs, attitudes, perceived benefits, barriers to uptake and sources of information. It further ascertains if healthcare professionals are sufficiently informed about PA and if they are advising pregnant women about the need for PA participation during pregnancy. Data will be collected through a structured questionnaire, interviews and focus group discussions. Information on socio-demographic and maternal characteristics will be obtained, and the Pregnancy Physical Activity Questionnaire (PPAQ) will assess PA during pregnancy. A sample size of 384 pregnant women is the required minimum sample for an infinite population at a confidence level of 95%, a precision level of ± 5% and at a prevalence of PA or exercise during pregnancy of 50% (p < 0.05); however, a sample size larger than the minimum number necessary will be recruited to account for possible attrition and to protect against possible data loss. Data will be analysed using a multiple logistic regression to determine the factors that predict sedentary or moderate PA levels and chi-squared analysis to determine the associations between the PA levels of the participants and socio-demographic and clinical variables. The study will assess the data collected on the above-mentioned variables and draw conclusions based on patterns and themes that emerge during analysis. Phase II of the study focuses on strategy development and validation to facilitate the promotion of PA during pregnancy. The developed strategy will be validated through the application of the Delphi technique and the administration of a checklist to selected key stakeholders through organised workshops. Understanding the level and correlates of PA participation among this special population is fundamental to designing intervention strategies to enhance their understanding of, and participation in, PA and exercise. Furthermore, this study's findings will inform facility-based healthcare providers about the need to integrate health education on PA and pregnancy into antenatal and postnatal care visits in the setting.

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Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.

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Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.

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