Dataset Information

A Physical Activity Intervention Feasibility Study for Kidney Inpatients: A Basic Research Protocol.

ABSTRACT:

Background

Low physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult kidney failure patients, regardless of treatment modality. Compared with the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, and higher cardiovascular morbidity and mortality. In addition, frail kidney failure patients have higher hospitalization and mortality rates as compared with other kidney failure patients. Evidence suggests that assessment and recommendations for physical activity should be part of standard care for kidney failure patients. Structured exercise can improve physical function and quality of life in frail older adults and may be used specifically for management of frailty in kidney failure. However, research is needed to determine best practices for implementation of physical function measurements and physical activity promotion in standard kidney failure care.

Objective

The proposed Move More study will assess the feasibility of a physical activity intervention offered to the kidney failure inpatients in Calgary, Alberta. Specifically, this study is designed to examine the effects of an early physical activity/mobility intervention led by a kinesiologist, and supported by the clinical care team including physiotherapists (PT) and nurse clinicians.

Methods

The Move More study is a single-arm pilot intervention examining feasibility and optimal improvement in real-world conditions. Kidney failure inpatients at the Foothills Medical Centre will be recruited to participate. Patients will receive an individualized in-hospital physical activity/mobility intervention. Frailty and physical function will be assessed at baseline and postintervention prior to hospital discharge. The goal is to recruit 24 to 36 patients.

Conclusions

Evidence needed to support the inclusion of mobility and physical activity as part of standard care will be gathered, with knowledge gained used to help direct future physical activity programming for kidney failure inpatients.

SUBMITTER: Wytsma-Fisher K

PROVIDER: S-EPMC7841695 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

A Physical Activity Intervention Feasibility Study for Kidney Inpatients: A Basic Research Protocol.

Wytsma-Fisher Kathryn K Mustata Stefan S Cowan Theresa T Ester Manuel M Culos-Reed S Nicole SN

Canadian journal of kidney health and disease 20210121

<h4>Background</h4>Low physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult kidney failure patients, regardless of treatment modality. Compared with the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, and higher cardiovascular morbidity and mortality. In addition, fr ...[more]

PMID: 33552530

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Project description:IntroductionPatients with chronic kidney disease (CKD) display increased infection-related mortality and elevated cardiovascular risk only partly attributed to traditional risk factors. Patients with CKD also exhibit a pro-inflammatory environment and impaired immune function. Aerobic exercise has the potential to positively impact these detriments, but is under-researched in this patient population. This feasibility study will investigate the effects of acute aerobic exercise on inflammation and immune function in patients with CKD to inform the design of larger studies intended to ultimately influence current exercise recommendations.Methods and analysisPatients with CKD, including renal transplant recipients, will visit the laboratory on two occasions, both preceded by appropriate exercise, alcohol and caffeine restrictions. On visit 1, baseline assessments will be completed, comprising anthropometrics, body composition, cardiovascular function and fatigue and leisure time exercise questionnaires. Participants will then undertake an incremental shuttle walk test to estimate predicted peak O2 consumption (VO2peak). On visit 2, participants will complete a 20 min shuttle walk at a constant speed to achieve 85% estimated VO2peak. Blood and saliva samples will be taken before, immediately after and 1 hour after this exercise bout. Muscle O2 saturation will be monitored throughout exercise and recovery. Age and sex-matched non-CKD 'healthy control' participants will complete an identical protocol. Blood and saliva samples will be analysed for markers of inflammation and immune function, using cytometric bead array and flow cytometry techniques. Appropriate statistical tests will be used to analyse the data.Ethics and disseminationA favourable opinion was granted by the East Midlands-Derby Research Ethics Committee on 18 September 2015 (ref 15/EM/0391), and the study was approved and sponsored by University Hospitals of Leicester Research and Innovation (ref 11444). The study was registered with ISRCTN (ref 38935454). The results will be presented at relevant conferences, and it is anticipated that the reports will be published in appropriate journals in 2018.

Project description:IntroductionCervical cancer treatment can have life changing sequelae and be associated with poor short-term and long-term quality of life. Physical activity (PA; that is, bodily movement) is known to improve health outcomes and quality of life for cancer survivors, both physically and psychologically. To date, no interventions to increase PA following cervical cancer have been evaluated. This study aims to (1) determine the feasibility of conducting a PA intervention after cervical cancer and (2) to explore the acceptability of the programme and evaluation measures.Methods and analysisThe design is a pre study and post study design. Thirty participants aged between 18 and 60 years from the Midlands region, UK, who have completed primary treatment for cervical cancer at least 6 months previously and do not meet the national PA guidelines will be recruited. Identification of potential participants will take place through the University Hospitals of Leicester National Health Service (NHS) Trust. Participants will receive an intervention focused on increasing PA through the provision of education, action planning, goal setting, problem solving and self-monitoring of PA behaviour, particularly steps per day. Device assessed PA and questionnaires will be completed at baseline, week 6, week 12 and week 24. Feasibility will be assessed in terms of recruitment, retention, attrition, completion of measures and intervention compliance, for which specific feasibility criteria have been established. The process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures.Ethics and disseminationEthical approval has been granted by the West of Scotland Research Ethics Committee 1 for this study. Results will inform intervention refinement for the design of a definitive pilot trial. These results will be disseminated via peer-reviewed publications and international conferences while input from a patient and public involvement (PPI) group will inform effective ways to circulate results among the wider community.Trial registration numberISRCTN16349793, Registered 30 September 2020.

Project description:BackgroundUntreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH.MethodsA two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population.DiscussionThis trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial.Trial registrationISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.

Project description:BackgroundFun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being and physical activity by providing capability-enhancing learning opportunities to participants. The conceptual framework for the FFW intervention is guided by self-efficacy theory. Evidence has been provided for the efficacy of FFW to promote self-reported free-living physical well-being actions in adults who comply with the intervention. The objective of this manuscript is to describe the protocol for a feasibility study designed to address uncertainties regarding the inclusion of accelerometer-based assessment of free-living physical activity within the FFW online intervention among adults with obesity in the United States of America (USA).MethodThe study design is a prospective, double-blind, parallel group randomized pilot trial. Thirty participants will be randomly assigned to the FFW or usual care (UC) group to achieve a 1:1 group (i.e., FFW:UC) assignment. Recruitment of participants is scheduled to begin on 29 April 2019 at a local bariatric services center within a major healthcare organization in the Midwest of the USA. There are five eligibility criteria for participation in this study: (1) between 18 and 64 years old, (2) a body mass index ≥ 25.00 kg/m2, (3) ability to access the online intervention, (4) the absence of simultaneous enrollment in another intervention program promoting physical activity, and (5) willingness to comply with instructions for physical activity monitoring. Eligibility verification and data collection will be conducted online. Three waves of data will be collected over a 13-week period. Instruments designed to measure demographic information, anthropometric characteristics, acceptability and feasibility of accelerometer-based assessment of physical activity, self-efficacy, and well-being will be included in the study. Data will be analyzed using descriptive statistics (e.g., recruitment rates), Pearson's correlation coefficient, Bland-Altman analyses, and inferential statistical models under both an intent to treat approach and a complier average causal effect approach.DiscussionResults are intended to inform the preparation of a future definitive randomized controlled trial.Trial registrationClinicalTrials.gov, NCT03906942, registered 8 April 2019.Trial fundingThe Erwin and Barbara Mautner Charitable Foundation and the Michigan State University College of Education.

Project description:Introduction Currently, only 1 in 4 children in the U.S. engage in the recommended amount of physical activity (PA) and disparities in PA participation increase as income inequities increase. Moreover, leading health organizations have identified rural health as a critical area of need for programming, research, and policy. Thus, there is a critical need for the development and testing of evidence-based PA interventions that have the potential to be scalable to improve health disparities in children from under-resourced rural backgrounds. As such, the present study utilizes human-centered design, a technique that puts community stakeholders at the center of the intervention development process, to increase our specific understanding about how the PA-based needs of children from rural communities manifest themselves in context, at the level of detail needed to make intervention design decisions. The present study connects the first two stages of the NIH Stage Model for Behavioral Intervention Development with a promising conceptual foundation and potentially sustainable college student mentor implementation strategy. Methods We will conduct a three-phase study utilizing human-centered community-based participatory research (CBPR) in three aims: (Aim 1) conduct a CBPR needs assessment with middle school students, parents, and teachers/administrators to identify perceptions, attributes, barriers, and facilitators of PA that are responsive to the community context and preferences; (Aim 2) co-design with children and adults to develop a prototype multi-level PA intervention protocol called Hoosier Sport; (Aim 3) assess Hoosier Sport’s trial- and intervention-related feasibility indicators. The conceptual foundation of this study is built on three complementary theoretical elements: (1) Basic Psychological Needs mini-theory within Self-Determination Theory; (2) the Biopsychosocial Model; and (3) the multilevel Research Framework from the National Institute on Minority Health and Health Disparities. Discussion Our CBPR protocol takes a human-centered approach to integrating the first two stages of the NIH Stage Model with a potentially sustainable college student mentor implementation strategy. This multidisciplinary approach can be used by researchers pursuing multilevel PA-based intervention development for children.

Project description:BACKGROUND:Physical activity (PA) reduces pain and improves functioning in people with knee osteoarthritis (OA), but few people with the condition meet recommended PA guidelines. Successful intervention strategies to increase PA include goal setting, action planning, self-monitoring, and follow-up feedback from a healthcare professional. Recently developed consumer wearable activity trackers allow users to set activity goals, self-monitor daily goal-progress, and provide feedback on goal attainment. It is hypothesized that a multi-component physiotherapist-led intervention that includes a short (40-min) education module, guided goal-setting and action planning, the use of a wristband activity tracker, and weekly follow-up phone calls will lead to increased PA outcomes. METHODS/DESIGN:Thirty-six participants will be recruited from the community for a two-group pilot randomized controlled trial with a stepped-wedge design using an intention-to-treat analysis. Computer-generated block randomization will be performed using varying block sizes and a 1:1 allocation ratio. The 4-week intervention will be delivered immediately (immediate-intervention group) or after a 5-week delay (delayed-intervention group). Outcome measures of pain and disability (Knee Injury and OA Outcome Score), disease self-management ability (Partners in Health Scale), and objective bouted moderate-to-vigorous PA and sedentary time (BodyMedia SenseWear Mini Armband) will be collected at baseline (week 0) and two follow-ups (weeks 5 and 10), for a total study duration of 11 weeks. Feasibility data relating to process, resource, management, and scientific elements of the trial will be collected. Outcome measure and feasibility data will be summarized, and an estimate of intervention efficacy will be obtained by regression model with planned comparisons. The trial began recruiting in February 2015. To date, 34 subjects have been recruited. DISCUSSION:This study will evaluate the feasibility and preliminary efficacy of a novel intervention to promote PA in people living with knee OA. The results will provide valuable information to inform a larger randomized trial to assess intervention effectiveness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02313506 (registration date 8 December 2014). First participant randomized 20 February 2015.

Project description:BackgroundThere is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer.ObjectiveThe Advanced stage Breast cancer and Lifestyle Exercise (ABLE) Trial aimed to assess the feasibility of a physical activity intervention in women with metastatic breast cancer and to explore the effects of physical activity on functional, psychological, and clinical parameters.MethodsThe ABLE Trial was a single-arm, 6-month intervention study with a home-based, unsupervised, and personalized walking program using an activity tracker. At baseline and 6 months, we assessed anthropometrics, functional fitness, physical activity level, sedentary behavior, quality of life, fatigue, and tumor progression. Paired proportions were compared using the McNemar test and changes of parameters during the intervention were analyzed using the Wilcoxon signed-rank test, the Mann-Whitney test, and Spearman rank correlations.ResultsOverall, 49 participants (mean age 55 years; recruitment rate 94%) were enrolled and 96% adhered to the exercise prescription (attrition rate 2%). Statistically significant improvements in the 6-minute walking distance test (+7%, P<.001) and isometric quadriceps strength (+22%, P<.001), as well as decreases in body mass index (-2.5%, P=.03) and hip circumference (-4.0%, P<.001) were observed at 6 months. Quality of life remained stable and a nonstatistically significant decrease (-16%, P=.07) in fatigue was observed.ConclusionsThe high recruitment and adherence rates suggest the willingness of patients with metastatic breast cancer to participate in a physical activity program. The beneficial outcomes regarding physical fitness and anthropometry of this unsupervised physical activity program may encourage these patients to maintain a physically active lifestyle. Future randomized controlled trials with larger sample sizes are warranted.Trial registrationClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886.

Dataset Information

A Physical Activity Intervention Feasibility Study for Kidney Inpatients: A Basic Research Protocol.

Background

Objective

Methods

Conclusions

Publications

A Physical Activity Intervention Feasibility Study for Kidney Inpatients: A Basic Research Protocol.

Similar Datasets

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