The Regulate your Sitting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: findings from a randomised-controlled feasibility trial.

BACKGROUND: Reducing and breaking up sitting is recommended for optimal management of Type 2 diabetes mellitus (T2DM). Yet, there is limited evidence of interventions targeting these outcomes in individuals with this condition. The primary aim of this study was to assess the feasibility and acceptability of delivering and evaluating a tailored online intervention to reduce and break up sitting in adults with T2DM. METHODS: A mixed-methods two-arm randomised controlled feasibility trial was conducted in ambulatory adults with T2DM who were randomised 1:1 to the REgulate your SItting Time (RESIT) intervention or usual care control group. The intervention included online education, self-monitoring and prompt tools (wearable devices, smartphone apps, computer apps) and health coaching. Feasibility outcomes were recruitment, attrition, data completion rates and intervention acceptability. Measurements of device-assessed sitting (intended primary outcome for definitive trial), standing and stepping, and physical function, psychosocial health and wellbeing were taken at baseline, 3 months and 6 months. Individual semi-structured interviews were conducted at six-months (post intervention) to explore acceptability, feasibility and experiences of the trial and intervention using the Framework Method. RESULTS: Seventy participants aged 55 ± 11 years were recruited. Recruitment rate (proportion of eligible participants enrolled into the study) was 67% and participant retention rate at 6 months was 93% (n = 5 withdrawals). Data completion rates for daily sitting were 100% at baseline and ranged from 83 to 91% at 3 months and 6 months. Descriptive analysis demonstrated potential for the intervention to reduce device-measured sitting, which was 30.9 ± 87.2 and 22.2 ± 82.5 min/day lower in the intervention group at 3 and 6 months, respectively, compared with baseline. In the control group, sitting was 4.4 ± 99.5 and 23.7 ± 85.2 min/day lower at 3 and 6 months, respectively. Qualitative analysis identified three themes: reasons for participating in the trial, acceptability of study procedures, and the delivery and experience of taking part in the RESIT intervention. Overall, the measurement visits and intervention were acceptable to participants. CONCLUSIONS: This study demonstrated the feasibility and acceptability of the RESIT intervention and evaluation methods, supporting a future definitive trial. If RESIT is found to be clinically effective, this could lead to changes in diabetes healthcare with a focus on reducing sitting. TRIAL REGISTRATION: The trial was registered with ISRCTN (number ISRCTN14832389).

The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease.

This trial assessed the feasibility and acceptability of Kidney BEAM, a physical activity and emotional well-being self-management digital health intervention (DHI) for people with chronic kidney disease (CKD), which offers live and on-demand physical activity sessions, educational blogs and videos, and peer support. In this mixed-methods, multicentre randomised waitlist-controlled internal pilot, adults with established CKD were recruited from five NHS hospitals and randomised 1:1 to Kidney BEAM or waitlist control. Feasibility outcomes were based upon a priori progression criteria. Acceptability was primarily explored via individual semi-structured interviews (n = 15). Of 763 individuals screened, n = 519 (68%, 95% CI 65 to 71%) were eligible. Of those eligible, n = 303 (58%, 95% CI 54-63%) did not respond to an invitation to participate by the end of the pilot period. Of the 216 responders, 50 (23%, 95% CI 18-29%) consented. Of the 42 randomised, n = 22 (10 (45%) male; 49 ± 16 years; 14 (64%) White British) were allocated to Kidney BEAM and n = 20 (12 (55%) male; 56 ± 11 years; 15 (68%) White British) to the waitlist control group. Overall, n = 15 (30%, 95% CI 18-45%) withdrew during the pilot phase. Participants completed a median of 14 (IQR 5-21) sessions. At baseline, 90-100% of outcome data (patient reported outcome measures and a remotely conducted physical function test) were completed and 62-83% completed at 12 weeks follow-up. Interview data revealed that remote trial procedures were acceptable. Participants' reported that Kidney BEAM increased their opportunity and motivation to be physically active, however, lack of time remained an ongoing barrier to engagement with the DHI. An randomised controlled trial of Kidney BEAM is feasible and acceptable, with adaptations to increase recruitment, retention and engagement.Trial registration NCT04872933. Date of first registration 05/05/2021.

Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK.

BACKGROUND: Remote digital health interventions to enhance physical activity provide a potential solution to improve the sedentary behaviour, physical inactivity, and poor health-related quality of life that are typical of chronic conditions, particularly for people with chronic kidney disease. However, there is a need for high-quality evidence to support implementation in clinical practice. The Kidney BEAM trial evaluated the clinical effect of a 12-week physical activity digital health intervention on health-related quality of life. METHODS: In a single-blind, randomised controlled trial conducted at 11 centres in the UK, adult participants (aged ≥18 years) with chronic kidney disease were recruited and randomly assigned (1:1) to the Kidney BEAM physical activity digital health intervention or a waiting list control group. Randomisation was performed with a web-based system, in randomly permuted blocks of six. Outcome assessors were masked to treatment allocation. The primary outcome was the difference in the Kidney Disease Quality of Life Short Form version 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between baseline and 12 weeks. The trial was powered to detect a clinically meaningful difference of 3 arbitrary units (AU) in KDQoL-SF1.3 MCS. Outcomes were analysed by an intention-to-treat approach using an analysis of covariance model, with baseline measures and age as covariates. The trial was registered with ClinicalTrials.gov, NCT04872933. FINDINGS: Between May 6, 2021, and Oct 30, 2022, 1102 individuals were assessed for eligibility, of whom 340 participants were enrolled and randomly assigned to the Kidney BEAM intervention group (n=173) or the waiting list control group (n=167). 268 participants completed the trial (112 in the Kidney BEAM group and 156 in the waiting list control group). All 340 randomly assigned participants were included in the intention-to treat population. At 12 weeks, there was a significant improvement in KDQoL-SF.13 MCS score in the Kidney BEAM group (from mean 44·6 AU [SD 10·8] at baseline to 47·0 AU [10·6] at 12 weeks) compared with the waiting list control group (from 46·1 AU [10·5] to 45·0 AU [10·1]; between-group difference of 3·1 AU [95% CI 1·8-4·4]; p<0·0001). INTERPRETATION: The Kidney BEAM physical activity platform is an efficacious digital health intervention to improve mental health-related quality of life in patients with chronic kidney disease. These findings could facilitate the incorporation of remote digital health interventions into clinical practice and offer a potential intervention worthy of investigation in other chronic conditions. FUNDING: Kidney Research UK.

Achieving consensus on psychosocial and physical rehabilitation management for people living with kidney disease.

Background: People living with chronic kidney disease (CKD) need to be able to live well with their condition. The provision of psychosocial interventions (psychological, psychiatric and social care) and physical rehabilitation management is variable across England, as well as the rest of the UK. There is a need for clear recommendations for standards of psychosocial and physical rehabilitation care for people living with CKD, and guidance for the commissioning and measurement of these services. The National Health Service (NHS) England Renal Services Transformation Programme (RSTP) supported a programme of work and modified Delphi process to address the management of psychosocial and physical rehabilitation care as part of a larger body of work to formulate a comprehensive commissioning toolkit for renal care services across England. We sought to achieve expert consensus regarding the psychosocial and physical rehabilitation management of people living with CKD in England and the rest of the UK. Methods: A Delphi consensus method was used to gather and refine expert opinions of senior members of the kidney multi-disciplinary team (MDT) and other key stakeholders in the UK. An agreement was sought on 16 statements reflecting aspects of psychosocial and physical rehabilitation management for people living with CKD. Results: Twenty-six expert practitioners and other key stakeholders, including lived experience representatives, participated in the process. The consensus (>80% affirmative votes) amongst the respondents for all 16 statements was high. Nine recommendation statements were discussed and refined further to be included in the final iteration of the 'Systems' section of the NHS England RSTP commissioning toolkit. These priority recommendations reflect pragmatic solutions that can be implemented in renal care and include recommendations for a holistic wellbeing assessment for all people living with CKD who are approaching dialysis, or who are at listing for kidney transplantation, which includes the use of validated measurement tools to assess the need for further intervention in psychosocial and physical rehabilitation management. It is recommended that the scores from these measurement tools be included in the NHS England Renal Data Dashboard. There was also a recommendation for referral as appropriate to NHS Talking Therapies, psychology, counselling or psychotherapy, social work or liaison psychiatry for those with identified psychosocial needs. The use of digital resources was recommended to be used in addition to face-to-face care to provide physical rehabilitation, and all healthcare professionals should be educated to recognize psychosocial and physical rehabilitation needs and refer/sign-post people with CKD to appropriate services. Conclusion: There was high consensus amongst senior members of the kidney MDT and other key stakeholders, including those with lived experience, in the UK on all aspects of the psychosocial and physical rehabilitation management of people living with CKD. The results of this process will be used by NHS England to inform the 'Systems' section of the commissioning toolkit and data dashboard and to inform the National Standards of Care for people living with CKD.

Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet?

PURPOSE OF REVIEW: The opportunity to review the more recent evidence for prescribing exercise-based physical rehabilitation for people living with chronic kidney disease (CKD) is timely. There has been a recent global focus evaluating how physical activity interventions might improve health-related quality of life and outcomes for people living with chronic health conditions in a post-COVID era. There is finally a long overdue commitment from the kidney research and clinical community to deliver pragmatic interventions to help people living with CKD to be able to live well with their condition. RECENT FINDINGS: This article reviews recent research, and discusses the challenges and potential solutions, for providing exercise-based therapeutic options for people living with CKD; including predialysis self-management interventions, options for both prehabilitation and posttransplant rehabilitation, pragmatic considerations for delivery of exercise therapy for people receiving haemodialysis treatment and the role of virtual kidney-specific rehabilitation. SUMMARY: Whilst there remains a need for further research in this area of patient care, there is now a body of evidence and kidney-specific guidelines that firmly support a rollout of pragmatic and scalable exercise-based interventions for people living with CKD. We are indeed nearly there now.

European Society of Organ Transplantation (ESOT) Consensus Statement on Prehabilitation for Solid Organ Transplantation Candidates.

There is increasingly growing evidence and awareness that prehabilitation in waitlisted solid organ transplant candidates may benefit clinical transplant outcomes and improve the patient's overall health and quality of life. Lifestyle changes, consisting of physical training, dietary management, and psychosocial interventions, aim to optimize the patient's physical and mental health before undergoing surgery, so as to enhance their ability to overcome procedure-associated stress, reduce complications, and accelerate post-operative recovery. Clinical data are promising but few, and evidence-based recommendations are scarce. To address the need for clinical guidelines, The European Society of Organ Transplantation (ESOT) convened a dedicated Working Group "Prehabilitation in Solid Organ Transplant Candidates," comprising experts in physical exercise, nutrition and psychosocial interventions, to review the literature on prehabilitation in this population, and develop recommendations. These were discussed and voted upon during the Consensus Conference in Prague, 13-15 November 2022. A high degree of consensus existed amongst all stakeholders including transplant recipients and their representatives. Ten recommendations were formulated that are a balanced representation of current published evidence and real-world practice. The findings and recommendations of the Working Group on Prehabilitation for solid organ transplant candidates are presented in this article.

The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial.

Half of kidney transplant recipients (KTRs) gain more than 5% of their body weight in the first year following transplantation. KTRs have requested support with physical activity (PA) and weight gain prevention, but there is no routine care offered. There are few high-quality studies investigating the clinical value of diet, PA or combined interventions to prevent weight gain. The development and evaluation of theoretically informed complex-interventions to mitigate weight gain are warranted. The aims of this mixed-methods randomized controlled trial (RCT) were to explore the feasibility, acceptability and user-experience of a digital healthcare intervention (DHI) designed to prevent post-transplant weight gain, in preparation for a large multi-center trial. New KTRs (<3 months) with access to an internet compatible device were recruited from a London transplant center. The usual care (UC) group received standard dietary and PA advice. The intervention group (IG) received access to a 12-week DHI designed to prevent post-transplant weight gain. Primary feasibility outcomes included screening, recruitment, retention, adherence, safety and hospitalizations and engagement and experience with the DHI. Secondary outcomes (anthropometrics, bioimpedance, arterial stiffness, 6-minute walk distance and questionnaires) were measured at baseline, 3- and 12-months. 38 KTRs were screened, of which 32 (84.2%) were eligible, and of those 20 (62.5%) consented, with 17 participants (85%) completing baseline assessment (Median 49 years, 58.8% male, Median 62 days post-transplant). Participants were randomized using a computer-generated list (n = 9 IG, n = 8 UC). Retention at 12-months was 13 (76.4%) (n = 6 IG, n = 7 UC). All a priori progression criteria were achieved. There were no associated adverse events. Reflexive thematic analysis revealed four themes regarding trial participation and experience whilst using the DHI. Halting recruitment due to COVID-19 resulted in the recruitment of 40% of the target sample size. Mixed-methods data provided important insights for future trial design. A definitive RCT is warranted and welcomed by KTRs. Clinical Trial Registration: www.clinicalTrials.gov, identifier: NCT03996551.

Cultural influences on physical activity and exercise beliefs in patients with chronic kidney disease: 'The Culture-CKD Study'-a qualitative study.

OBJECTIVES: This study used a mixed-method approach to explore cultural and ethnic influences on the perception of, and decision to engage with or not to engage with, physical activity and exercise therapy in patients with chronic kidney disease (CKD). DESIGN: Qualitative research was conducted through the use of semistructured interviews and focus groups. Self-reported physical activity levels were measured using the General Practice Physical Activity Questionnaire (GPPAQ), and self-efficacy for exercise with Bandura's Self-Efficacy for Exercise Scale. SETTING: This study was conducted in a non-clinical setting of a single National Health Service Hospital Trust between April 2018 and July 2019. PARTICIPANTS: Participants >18 years of age with a diagnosis of CKD, from black African, black Caribbean, South Asian or white ethnicity were eligible for the study. 84 patients with a diagnosis of CKD (stages 2-5), aged 25-79 (mean age 57) were recruited. Semistructured interviews (n=20) and six single-sex, ethnic-specific focus group discussions were undertaken (n=36). OUTCOMES: Primary outcome was to explore the perceptions, attitudes and values about exercise and physical activity in different ethnic groups through qualitative interviews, analysed using an inductive thematic analysis approach. Questionnaires were analysed using Pearson correlation to determine if there was a significant relationship between the self-efficacy and GPPAQ levels. RESULTS: Qualitative analysis provided four primary themes: I am who I am, Change of identity, Influences to physical activity and exercise and Support and education. Quantitative analysis using Pearson correlation revealed a significant correlation between GPPAQ levels of activity and self-efficacy to regulate exercise behaviour (r=-0.40, p=0.001). CONCLUSION: Understanding the cultural, attitudes and beliefs of individuals with CKD from a variety of ethnic backgrounds is complex. Understanding of patients' experiences, thoughts and beliefs may be of relevance to clinicians when designing CKD exercise services. TRIAL REGISTRATION NUMBER: NCT03709212; Pre-results.

Usability and experience testing to refine an online intervention to prevent weight gain in new kidney transplant recipients.

OBJECTIVES: Weight gain in the first year following kidney transplantation increases the risk of adverse health outcomes. Currently, there is no recognized intervention available to prevent weight gain after kidney transplantation. An online kidney transplant-specific resource, entitled Exercise in Renal Transplant Online (ExeRTiOn), has been co-created by a multi-professional team, including patients, to assist with weight prevention. This study aimed to evaluate patient and health care professional usability and experience of the ExeRTiOn online resource. DESIGN: Qualitative study utilizing 'Think-Aloud' and semi-structured interviews. METHODS: Participants (n = 17) were purposively sampled to include new kidney transplant recipients (n = 11) and transplant health care professionals (n = 6). Kidney transplant recipient participants were from a spread of physical activity levels based on scores from the General Practice Physical Activity Questionnaire (GPPAQ). 'Think-Aloud' interviews assessed the usability of ExeRTiOn. Semi-structured interviews explored participants' experience of ExeRTiOn, weight gain, and physical activity. The data set were analysed thematically. Participant characteristics, including login data and self-reported body weight, were collected. RESULTS: Data analyses identified valued intervention content and usability aspects which were summarized by two themes. The first theme 'You need to know how to manage yourself' included subthemes: (1) the resource filled a guidance gap, (2) expert patient content resonated, and (3) the importance of goal setting and monitoring progress. The second theme 'room for improvement' included subthemes: (2) web support and (2) content and operational change suggestions. CONCLUSIONS: Results have allowed for identification of potential areas for resource refinement. This has facilitated iterative enhancement of ExeRTiOn in preparation for a randomized controlled feasibility trial.

Test-Retest Reliability for Physical Function Measures in Patients with Chronic Kidney Disease.

BACKGROUND: It is important to determine relative and absolute reliability values in outcome measures that are used in clinical practice so as to discriminate between true changes following exercise interventions for patients with chronic kidney disease (CKD). OBJECTIVE: The study aimed to assess test-retest reliability of the incremental shuttle walk test (ISWT), sit-to-stand transfers in 60 seconds (STS-60), timed up and go (TUAG), Duke's activity status index (DASI) and hospital anxiety and depression scale (HAD) in patients with CKD. STUDY DESIGN: This study was a pragmatic non-randomised controlled trial. METHODS: Forty people attended two study visits within a 16-day window involving the ISWT, STS-60, TUAG, DASI and HAD tests. Relative reliability was assessed using intraclass correlation coefficient (ICC) and absolute reliability using the standard error of measurement (SEM) and minimal detectable change (MDC). RESULTS: Good test-retest reliability was found for the entire sample size across all outcome measures, with TUAG having the highest (ICC = 0.96) and HAD the lowest (ICC = 0.71). The MDC scores at 90% confidence interval (CI) were: 79.6 m for the ISWT, 2.9 seconds for the TUAG, 7.0 repetitions for the STS-60, 8.4 for the DASI, 3.8 for the anxiety HAD subscale and 4.4 for the depression HAD subscale. CONCLUSIONS: This study demonstrated good test-retest reliability for all outcome measures across the CKD trajectory but caution needs to be taken when interpreting the findings for each CKD sub-group separately. The MDC scores at 90% CI can support therapists in determining a true improvement in CKD patients' physical or mental performance.

Arterial stiffness is a predictor for acute kidney injury following coronary artery bypass graft surgery.

BACKGROUND: Cardiac surgery-associated acute kidney injury (CSA-AKI) is a serious postoperative complication of cardiac surgery, an episode of which impacts on patient morbidity and mortality. Pulse wave velocity (PWV; a non-invasive measurement tool to assess arterial stiffness) has been shown to predict kidney disease progression, and cardiovascular and all-cause mortality in patients with chronic kidney disease. We hypothesised that PWV would also predict acute kidney injury in subjects who have undergone non-valve repair elective coronary artery bypass graft (CABG) surgery . METHODS: This was a prospective, observational, exploratory study. PWV was determined with a Vicorder device, together with standard clinical and biochemical parameters. AKI staging was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines. RESULTS: 137 patients were included in the study. 85% were male, and mean age was 66.3 years (SD = 9.7 years). There were 40 episodes (29%) of CSA-AKI. Each 1 unit increase in PWV score was associated with a 1.5 fold greater odds of a CSA-AKI event (p = 0.006(odds ratio = 1.5; confidence interval:1.13-2.10). A 1 unit increase in estimated glomerular filtration rate resulted in an estimated 85% decrease in the odds of developing AKI, each year, men have an odds reduction of 15% of developing AKI compared with females and each 1 year increase in age lowered the odds of developing AKI by 87%. CONCLUSIONS: This pilot exploratory study revealed that PWV, assessed prior to non-valve repair elective CABG surgery, independently predicts CSA-AKI events. PWV is a simple, non-invasive technique that could potentially be used to risk stratify for CSA- AKI following elective cardiac surgery. TRIAL REGISTRATION: ClinTrial.Gov NCT02364427 . Registered 18 February 2015.

Mortality and morbidity following exercise-based renal rehabilitation in patients with chronic kidney disease: the effect of programme completion and change in exercise capacity.

BACKGROUND: Twelve weeks of renal rehabilitation (RR) have been shown to improve exercise capacity in patients with chronic kidney disease (CKD); however, survival following RR has not been examined. METHODS: This study included a retrospective longitudinal analysis of clinical service outcomes. Programme completion and improvement in exercise capacity, characterised as change in incremental shuttle walk test (ISWT), were analysed with Kaplan-Meier survival analyses to predict risk of a combined event including death, cerebrovascular accident, myocardial infarction and hospitalisation for heart failure in a cohort of patients with CKD. Time to combined event was examined with Kaplan-Meier plots and log rank test between 'completers' (attended >50% planned sessions) and 'non-completers'. In completers, time to combined event was examined between 'improvers' (≥50 m increase ISWT) and 'non-improvers' (<50 m increase). Differences in time to combined event were investigated with Cox proportional hazards models (adjusted for baseline kidney function, body mass index, diabetes, age, gender, ethnicity, baseline ISWT and smoking status). RESULTS: In all, 757 patients (male 54%) (242 haemodialysis patients, 221 kidney transplant recipients, 43 peritoneal dialysis patients, 251 non-dialysis CKD patients) were referred for RR between 2005 and 2017. There were 193 events (136 deaths) during the follow-up period (median 34 months). A total of 43% of referrals were classified as 'completers', and time to event was significantly greater when compared with 'non-completers' (P = 0.009). Responding to RR was associated with improved event-free survival time (P = 0.02) with Kaplan-Meier analyses and log rank test. On multivariate analysis, completing RR contributed significantly to the minimal explanatory model relating clinical variables to the combined event (overall χ2 = 38.0, P < 0.001). 'Non-completers' of RR had a 1.6-fold [hazard ratio = 1.6; 95% confidence interval (CI) 1.00-2.58] greater risk of a combined event (P = 0.048). Change in ISWT of >50 m contributed significantly to the minimal explanatory model relating clinical variables to mortality and morbidity (overall χ2 = 54.0, P < 0.001). 'Improvers' had a 40% (hazard ratio = 0.6; 95% CI 0.36-0.98) independent lower risk of a combined event (P = 0.041). CONCLUSIONS: There is an association between completion of an RR programme, and also RR success, and a lower risk of a combined event in this observational study. RR interventions to improve exercise capacity in patients with CKD may reduce risk of morbidity and mortality, and a pragmatic randomised controlled intervention trial is warranted.