Dataset Information

Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial.

ABSTRACT:

Background

Frailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD.

Methods

Participants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability.

Results

Six hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence.

Conclusions

This pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD.

Trial registration

ISRCTN87708989; https://clinicaltrials.gov/.

SUBMITTER: Nixon AC

PROVIDER: S-EPMC8248609 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%-89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.

Project description:Introduction: Recently, we developed a home-based, minimal-equipment exercise training program HOMEX for people with chronic obstructive pulmonary disease (COPD) and tested its effectiveness over 1 year in a randomized controlled trial. The aims of the current study were to evaluate the implementation of HOMEX from the perspectives of all involved persons and to optimize the program to ensure its long-term sustainability. Methods: In this mixed-methods study, we used qualitative and quantitative approaches to evaluate the implementation of the intervention on the level of patients with COPD and coaches who provided the intervention and relevant stakeholders. To assess the implementation outcomes dose, reach, fidelity, and adherence, we summarized information recorded in the notes of the coaches and the diaries of patients, complemented with results from qualitative assessments. To assess acceptability and appropriateness, we conducted surveys with patients and coaches, and semistructured interviews with selected patients, coaches, and stakeholders. Results: The coaches delivered the three home visits with one exception according to the protocol (fidelity). Of the 53 intervention group participants, 37 (70%) conducted HOMEX training until the end of the study and 43 (79%) trained for at least 10 months. The exercise behaviors of the participants could be separated into the phases "Starting the training and stabilizing into regular training routine" and "Managing training disruptions" (adherence). Overall, patients, coaches, and stakeholders conveyed a very high "acceptability" of HOMEX, noting the home-based aspect as a particular strength and interaction with other patients as future need. All involved groups perceived the strength-training exercises as appropriate, efficient for people with COPD, and relevant to maintain improvements after pulmonary rehabilitation. The most important facilitators of the patients for long-term motivation were self-perceived improvement in strength, supervision by a coach, and integration of the training in daily routine. Based on these insights, we redesigned and reworded the exercise cards, introduced three new exercises, and refined the training book. Discussion: The results of this study provided insights of the involved persons in the frame of the HOMEX intervention implementation with a particular focus on the long-term training behavior of the participants and their perception and experience with the exercise program. These findings enabled us to optimize the training material and adapt the structure of the program for sustainable further use in clinical and other settings.

Project description:BackgroundCardiovascular disease (CVD) is a major cause of morbidity and mortality in kidney transplant recipients (KTRs). CVD risk scores underestimate risk in this population as CVD is driven by clustering of traditional and non-traditional risk factors, which lead to prognostic pathological changes in cardiovascular structure and function. While exercise may mitigate CVD in this population, evidence is limited, and physical activity levels and patient activation towards exercise and self-management are low. This pilot study will assess the feasibility of delivering a structured, home-based exercise intervention in a population of KTRs at increased cardiometabolic risk and evaluate the putative effects on cardiovascular structural and functional changes, cardiorespiratory fitness, quality of life, patient activation, healthcare utilisation and engagement with the prescribed exercise programme.Methods and analysisFifty KTRs will be randomised 1:1 to: (1) the intervention; a 12week, home-based combined resistance and aerobic exercise intervention; or (2) the control; usual care. Intervention participants will have one introductory session for instruction and practice of the recommended exercises prior to receiving an exercise diary, dumbbells, resistance bands and access to instructional videos. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the intervention implementation. Outcomes, to be assessed prior to randomisation and postintervention, include: cardiac structure and function with stress perfusion cardiac MRI, cardiorespiratory fitness, physical function, blood biomarkers of cardiometabolic health, quality of life and patient activation. These data will be used to inform the power calculations for future definitive trials.Ethics and disseminationThe protocol was reviewed and given favourable opinion by the East Midlands-Nottingham 2 Research Ethics Committee (reference: 19/EM/0209; 14 October 2019). Results will be published in peer-reviewed academic journals and will be disseminated to the patient and public community via social media, newsletter articles and presentations at conferences.Trial registration numberNCT04123951.

Project description:BackgroundJob loss, austerity measures, financial difficulties and house repossession contribute to the risk of self-harm and suicide during recessions. Navigating the benefits system and accessing sources of welfare and debt advice is a difficult experience for vulnerable people, further contributing to their distress. Whilst there is some evidence that advice-type interventions can lead to financial gain, there is mixed evidence for their effectiveness in improving mental health in those experiencing financial difficulties. There have been no interventions targeting those who have self-harmed due to economic hardship.MethodsOur aim was to determine the feasibility and acceptability of a brief psychosocial intervention (the 'HOPE' service) for people presenting to hospital emergency departments (ED) following self-harm or in acute distress because of financial, employment or welfare (benefit) difficulties. Nineteen people consented to random allocation to the intervention or control arm on a 2:1 basis. Participants randomised to the intervention arm (n =?13) received up to six sessions of 1:1 support provided by community support staff trained in Motivational Interviewing (MI). Control participants (n =?6) received a one-off session signposting them to relevant support organisations. Fourteen participants were followed up after 3 months. Participants and mental health workers took part in qualitative interviews. The acceptability of outcome measures including the PHQ-9, GAD-7, repeat self-harm, EQ5D-5 L and questions about debt, employment and welfare benefits were explored.ResultsInterviews indicated the main benefits of the service as the resolution of specific financial problems and receiving support when participants were feeling most vulnerable. Randomisation was acceptable to most participants although not always fully understood and control participants could be disappointed. Recruitment was slow (1-2 per month). The outcome measures were acceptable and appeared sensitive to change.DiscussionThe HOPE intervention is feasible and acceptable. There was evidence of need and it is a relatively inexpensive intervention. Refining aspects of the intervention would be straightforward. A full-scale RCT would be feasible, if broadened eligibility criteria led to increased recruitment and improvements were made to staff training and support.Trial registrationISRCTN58531248.

Project description:BackgroundEstimates suggest that 6.2 million Americans aged ≥65 years are living with Alzheimer dementia in 2021, and by 2060, this number could more than double to 13.8 million. As a result, public health officials anticipate a greater need for caregivers of persons with Alzheimer disease or related dementia and support resources for both people living with dementia and their caregivers. Despite the growing need for dementia caregiver support services, there is a lack of consensus regarding how to tailor these services to best meet the heterogeneous needs of individual caregivers. To fill this gap, Care to Plan (CtP), a web-based tool for caregivers of people living with dementia, was developed to provide tailored support recommendations to dementia caregivers.ObjectiveThe aim of this study is to formally explore the feasibility, acceptability, and utility of CtP for 20 family members of people living with dementia within a health system over a 1-month time period using a mixed methods parallel convergent design.MethodsA moderately sized health system in the mid-Atlantic region was selected as the site for CtP implementation, where 20 caregivers who were family members of people living with dementia were enrolled. The web-based CtP tool was used by caregivers and facilitated by a health care professional (ie, a senior care navigator [SCN]). Caregivers were given a 21-item review checklist to assess barriers and facilitators associated with reviewing CtP with an SCN. Following the 21-item review checklist, semistructured telephone interviews, which included 18 open-ended questions, focused on the facilitators of and barriers to CtP implementation and recommendations for future implementation.ResultsQuantitative results suggested that 85% (17/20) of caregivers indicated that CtP was helpful and 90% (18/20) would recommend CtP to someone in a similar situation. The qualitative analysis identified 4 themes regarding facilitators of and barriers to implementation: caregiver factors, SCN factors, CtP tool system factors, and recommendations and resources factors.ConclusionsCtP was found to be not only feasible but also a valuable tool for caregivers seeking resources for themselves and their people living with dementia. Long-term evaluation findings aim to generate results on how CtP can be integrated into care plans for caregivers and how SCNs can provide additional support for caregivers of people living with dementia over an extended period.