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Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study.

ABSTRACT: OBJECTIVES:Frailty 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. DESIGN:Mixed-methods feasibility. SETTING AND PARTICIPANTS:Prevalent 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. INTERVENTIONS:Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC). OUTCOMES:Primary 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. RESULTS:124 (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. CONCLUSIONS:A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population. TRIAL REGISTRATION NUMBERS:ISRCTN11299707; ISRCTN12840463.

SUBMITTER: Young HML

PROVIDER: S-EPMC7640592 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study.

Young Hannah M L HML March Daniel S DS Highton Patrick J PJ Graham-Brown Matthew P M MPM Churchward Darren C DC Grantham Charlotte C Goodliffe Samantha S Jones William W Cheung Mei-Mei MM Greenwood Sharlene A SA Eborall Helen C HC Conroy Simon S Singh Sally J SJ Smith Alice C AC Burton James O JO

BMJ open 20201103 11

<h4>Objectives</h4>Frailty 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.<h4>Design</h4>Mixed-methods feasibility.<h4>Setting and participants</h4>Prevalent adult HD patients of the <i>CYCLE-HD</i> trial with a Clinical Frailty Scale Score of 4-7 (vulnerable to severel ...[more]

PMID: 33148767

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Project description:BackgroundFrailty 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.MethodsParticipants 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.ResultsSix 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.ConclusionsThis 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 registrationISRCTN87708989; https://clinicaltrials.gov/.

Project description:BackgroundHaemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis.MethodsA parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation.ResultsOut of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation.ConclusionAn arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496 .

Project description:BackgroundFrailty is associated with multiple adverse outcomes in stage-5 chronic kidney disease (CKD-5) and upwards of one third of people receiving haemodialysis (HD) are frail. While many frailty screening methods are available in both uremic and non-uremic populations, their implementation in clinical settings is often challenged by time and resource constraints. In this study, we explored the diagnostic accuracy of time-efficient screening tools in people receiving HD.MethodsA convenience sample of 76 people receiving HD [mean age = 61.1 years (SD = 14), 53.9% male] from three Renal Units were recruited for this cross-sectional study. Frailty was diagnosed by means of the Fried phenotype. Physical performance-based screening tools encompassed handgrip strength, 15-ft gait speed, timed up and go (TUG), and five-repetition sit to stand (STS-5) tests. In addition, participants completed the SF-36 Health Survey, the short-form international physical activity questionnaire and the Tinetti falls efficacy scale (FES) as further frailty-related measures. Outcome measures included the area under the curve (AUC), sensitivity, specificity, positive (PPV) and negative predictive values (NPV). The diagnostic performance of screening tools in assessing fall-risk was also investigated.ResultsOverall, 36.8% of participants were classified as frail. All the examined instruments could significantly discriminate frailty status in the study population. Gait speed [AUC = 0.89 (95%CI: 0.81-0.98), sensitivity = 75%, specificity = 93%] and TUG [AUC = 0.90 (95%CI: 0.80-0.99), sensitivity = 89%, specificity = 85%] exhibited the highest diagnostic accuracy. There was a significant difference in gait speed AUC (20%, p = 0.013) between participants aged 65 years or older (n = 36) and those under 65 years of age (n = 40), with better discriminating performance in the younger sub-group. The Tinetti FES was the only instrument showing good diagnostic accuracy (AUCs≥0.80) for both frailty (sensitivity = 82%, specificity = 79%) and fall-risk (sensitivity = 82%, specificity = 71%) screening.ConclusionsThis cross-sectional study revealed that time- and cost-efficient walking performance measures can accurately be used for frailty-screening purposes in people receiving HD. While self-selected gait speed had an excellent performance in people under 65 years of age, TUG may be a more suitable screening method for elderly patients (≥65 years). The Tinetti FES may be a clinically useful test when physical testing is not achievable.

Project description:BackgroundFrailty is highly prevalent in people receiving haemodialysis (HD) and is associated with poor outcomes. Understanding the lived experiences of this group is essential to inform holistic care delivery.MethodsSemi-structured interviews with N = 25 prevalent adults receiving HD from 3 HD units in the UK. Eligibility criteria included a Clinical Frailty Scale (CFS) score of 4-7 and a history of at least one fall in the last 6 months. Sampling began guided by maximum variation sampling to ensure diversity in frailty status; subsequently theoretical sampling enabled exploration of preliminary themes. Analysis was informed by constructivist grounded theory; later we drew upon the socioecological model.ResultsParticipants had a mean age of 69 ± 10 years, 13 were female, and 13 were White British. 14 participants were vulnerable or mildly frail (CFS 4-5), and 11 moderately or severely frail (CFS 6-7). Participants characterised frailty as weight loss, weakness, exhaustion, pain and sleep disturbance arising from multiple long-term conditions. Participants' accounts revealed: the consequences of frailty (variable function and psychological ill-health at the individual level; increasing reliance upon family at the interpersonal level; burdensome health and social care interactions at the organisational level; reduced participation at the community level; challenges with financial support at the societal level); coping strategies (avoidance, vigilance, and resignation); and unmet needs (overprotection from family and healthcare professionals, transactional health and social care exchanges).ConclusionsThe implementation of a holistic needs assessment, person-centred health and social care systems, greater family support and enhancing opportunities for community participation may all improve outcomes and experience. An approach which encompasses all these strategies, together with wider public health interventions, may have a greater sustained impact.Trial registrationISRCTN12840463 .

Project description:BACKGROUND:Frailty exposes older people to an elevated risk of a range of negative outcomes. Emerging evidence that frailty can be effectively treated within community settings has stimulated calls for more proactive screening within primary care. Assessing feasibility is a critical preliminary step in assessing the efficacy of interventions such as screening. However, few studies have explored the feasibility and acceptability of administering frailty screening instruments within general practice, and even fewer have incorporated patient perspectives. Our study had three objectives: To 1) assess overall feasibility of the instruments (completion time and rate); 2) assess patient acceptability towards the instruments; and 3) assess the feasibility and acceptability of the instruments to administering nurses. METHODS:The feasibility and acceptability of several frailty screening instruments (PRISMA-7, Edmonton Frail Scale, FRAIL Scale Questionnaire, Gait Speed, Groningen Frailty Indicator, Reported Edmonton Frail Scale and Kihon Checklist) was explored within the context of a larger diagnostic test accuracy (DTA) study. Completion time and rate was collected for all participants (N =?243). A sub-sample of patients (n =?30) rated each instrument for ease of completion and provided comment on perceived acceptability. Lastly, five of six administering nurses involved in the DTA study participated in semi-structured face-to-face interviews, rating the instruments against several feasibility and acceptability criteria (time, space, equipment, skill required to implement, acceptability to patients and nurses, ease of scoring) and providing comment on their responses. RESULTS:The PRISMA-7 returned the highest overall feasibility and acceptability, requiring minimal space, equipment, skills and time to implement, and returning the fastest completion rate and highest patient and nurse acceptability rating. All screening instruments were faster to implement than the two reference standards (Fried's Frailty Phenotype and Frailty Index). Self-administered instruments were subject to lower rates of completion than nurse-administered instruments. CONCLUSIONS:This study has demonstrated that a number of commonly used frailty screening instruments are potentially feasible for implementation within general practice. Ultimately, more research is needed to determine how contextual factors, such as differences in individual patient and clinician preferences, setting and system factors, impact on the feasibility of screening in practice.

Project description:OBJECTIVES:For people with end-stage renal disease requiring haemodialysis, exercise can improve aspects of quality of life (QoL). However, the relative benefits and risks of different types of exercise in this population are unknown. Therefore, this pilot study aimed to evaluate the feasibility of a main study evaluating the efficacy of cycling and resistance exercise each performed during the haemodialysis treatment on QoL. METHODS:In this factorial (2×2) pilot trial, 31 haemodialysis patients were randomised to cycling, resistance, cycling and resistance, or an attention control. Feasibility was defined a priori by criteria on recruitment, fidelity to the protocol and patient response to the intervention. To better understand feasibility, we conducted interviews with dialysis unit staff and trial participants. As secondary outcomes, we estimated the main effect of cycling and weights each compared with control on QoL, physical function and strength. FINDINGS:We exceeded the target accrual of 28 participants over 12?weeks. Irrespective of exercise group allocation, adherence was high; of the 1038 training sessions offered, 87% were initiated and over 80% of exercise sessions were performed as per protocol. Progression based on perceived exertion, individual instruction and interactions with the kinesiologist facilitated acceptability across exercise groups. Using an attention control, measures of contamination and attrition were low. Important barriers to unit staff readiness for the intervention were initial safety and workflow concerns, unit workload and onerous data collection. Secondary outcomes were not statistically significant. Adverse events were low and did not increase with a higher volume of exercise. CONCLUSIONS:The main study is feasible with minor modifications. In addition to practical assistance, involvement from unit staff could increase patient participation and improve trial implementation. Strategies to increase acceptability of the intervention for staff include improving workflow integration and using a prestudy demonstration phase to introduce the intervention. TRIAL REGISTRATION NUMBER:NCT02234232.

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:BackgroundPeople living with Alzheimer disease and related dementias (ADRD) require prolonged and complex care that is primarily managed by informal caregivers who face significant unmet needs regarding support for communicating and coordinating across their informal care network. To address this unmet need, we developed CareVirtue, which provides (1) the ability to invite care network members; (2) a care guide detailing the care plan; (3) a journal where care network members can document, communicate, and coordinate; (4) a shared calendar; and (5) vetted geolocated caregiver resources.ObjectiveThis study aims to evaluate CareVirtue's feasibility based on: (1) Who used CareVirtue? (2) How did caregivers use CareVirtue? (3) How did caregivers perceive the acceptability of CareVirtue? (4) What factors were associated with CareVirtue use?MethodsWe conducted a feasibility study with 51 care networks over a period of 8 weeks and used a mixed methods approach that included both quantitative CareVirtue usage data and semistructured interviews.ResultsCare networks ranged from 1 to 8 members. Primary caregivers were predominantly female (38/51, 75%), White (44/51, 86%), married (37/51, 73%), college educated (36/51, 71%), and were, on average, 60.3 (SD 9.8) years of age, with 18% (9/51) living in a rural area. CareVirtue usage varied along 2 axes (total usage and type of usage), with heterogeneity in how the most engaged care networks interacted with CareVirtue. Interviews identified a range of ways CareVirtue was useful, including practically, organizationally, and emotionally. On the Behavioral Intention Scale, 72% (26/36) of primary caregivers reported an average score of at least 3, indicating an above average intention to use. The average was 81.8 (SD 12.8) for the System Usability Scale score, indicating "good" usability, and 3.4 (SD 1.0) for perceived usefulness, suggesting above average usefulness. The average confidence score increased significantly over the study duration from 7.8 in week 2 to 8.9 in week 7 (P=.005; r=0.91, 95% CI 0.84-0.95). The following sociodemographic characteristics were associated with posting in the journal: retired (mean 59.5 posts for retired caregivers and mean 16.9 for nonretired caregivers), income (mean 13 posts for those reporting >US $100K and mean 55.4 for those reporting <US $100K), relationship to care recipient (mean 18.7 posts for child and mean 56.4 for partners/spouses), and living situation (mean 44.7 for those who live with the care recipient and mean 13.1 for those who do not). Older care recipients were associated with fewer posts (r=-0.33, 95% CI -0.55 to -0.06).ConclusionsThis study establishes the acceptability and feasibility of CareVirtue among ADRD care networks and highlights the importance of designing flexible, multicomponent interventions that allow care networks to tailor their engagement according to their needs. The results will be used to improve CareVirtue feasibility and acceptability in preparation for a subsequent randomized trial to test CareVirtue's effectiveness in improving caregiver outcomes.

Project description:IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3-4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.

Dataset Information

Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study.

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Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study.

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