Intradialytic Exercise Program Research Articles

#2786 Effect of intradialytic virtual reality exercise program on lower limb muscle strength in patients on hemodialysis

Abstract Background and Aims In patients on hemodialysis, muscle weakness is highly prevalent and may lead to frailty, limitation of mobility and functional impairment. Moreover, low muscle strength was associated with an increase in mortality risk in these patients. Despite the fact that some studies showed that resistance training improves muscle strength in patients on hemodialysis, the effects of virtual reality (VR) exercise should be confirmed. Therefore, the aim of this study was to evaluate the effects of an intradialytic non-immersive VR exercise program, performed at different times during the hemodialysis session, on lower limb muscle strength in patients on hemodialysis. Method A randomized clinical trial was conducted with patients aged ≥18 years who were undergoing hemodialysis treatment for at least 3 months. Patients were randomized into 2 protocols of exercise at different times during the hemodialysis session (first 2 hours and last two hours) for 3 months. The intradialytic exercise program in both groups consisted of a non-immersive VR game (Treasure Hunting) in which the patients try to catch treasures and avoid bombs by moving their lower limbs (hip flexion, abduction and adduction, and knee flexion and extension), with a progressive duration of 6 to 36 minutes. The difficulty level of the game was graduated according to the characteristics of each patient. The muscle strength of the hip flexion (HF), hip abduction (HA) and ankle extension (AE) was evaluated using a portable handheld dynamometer during hemodialysis session. Patients were advised to perform a 5 s maximum isometric contraction, and the peak values were recorded for 3 repetitions in both lower limbs. The mean muscle strength of 3 trials was recorded. Data were expressed as the median (interquartile range). The Mann‒Whitney U test was used for between-group comparisons. The Friedman test was conducted to evaluate the differences in medians among the muscle strength data at baseline, after 1, 2 and 3 months of exercise program. Results This study included 11 patients in the exercise within the first 2 hours group [50 (55-75) years, 55% male] and 11 patients in the exercise within the last 2 hours group [64 (58-72) years, 64% male]. Table 1 shows that muscle strength of the HA and AE increased significantly in the exercise within the first 2 hours group. Muscle strength of HF, HA and AE improved significantly in the exercise within the last 2 hours group. There were no significant differences between two groups. Conclusion This study suggests that an intradialytic non-immersive VR exercise program can improve lower limb muscle strength in patients on hemodialysis.

#1192 Impact of intradialytic exercise on all-cause mortality in frail patients undergoing hemodialysis: a three-year multicenter cohort study

Abstract Background and Aims Frailty prevalence is notably high among older hemodialysis patients, correlating with poorer prognoses. Prior smaller-scale studies have underscored the benefits of various exercise interventions in individuals with Chronic Kidney Disease and those receiving dialysis treatments. Addressing frailty in older hemodialysis patients by exercise therapy is crucial for healthcare professionals aiming to enhance patient outcomes. Despite this, a standardized exercise therapy protocol for this demographic has not been broadly implemented in clinical practice. Our study sought to evaluate the impact of intradialytic resistance exercise programs on the prognosis of frail individuals undergoing hemodialysis. Method This retrospective, multicenter, non-randomized clinical trial encompassed 2006 participants (mean age 70.1±11.7 years) from 17 outpatient clinics within the Kaikoukai Medical Group. Enrollment spanned from April to December 2018, with patients stratified according to baseline frailty levels, determined by the Japanese Frailty Criteria for the Diagnosis of Frailty in the Elderly. In this study, patients meeting the criteria for frailty or pre-frailty, as defined by the Japanese Criteria for Health and Social Services (J-CHS), were collectively classified as 'frail’. Participants were invited to join a voluntary exercise program during dialysis, which included stretching and four types of resistance exercises using elastic tubes. The cohort was divided into four groups based on their frailty status and participation in the exercise program. Patient outcomes were monitored until either death or the study's conclusion in December 2021. Kaplan-Meier and log-rank analyses were utilized to assess prognostic differences among the groups, with significance levels adjusted using the Bonferroni correction. Ethical approval was granted by the Nagoya Kyoritsu Hospital's ethical committee. Results The study comprised 112 non-frail exercising, 398 frail exercising, 205 non-frail non-exercising, and 1287 frail non-exercising patients. Over the study period (median 25 months), mortality was recorded in 338 (16.9%) patients, including 8 (7.1%) non-frail exercising, 50 (12.6%) frail exercising, 16 (7.8%) non-frail non-exercising, and 264 (20.5%) frail non-exercising participants. Prognostic analysis revealed that the frail non-exercising group had a significantly poorer prognosis than both the non-frail exercising and non-frail non-exercising groups, as well as the frail exercising group (p<0.05). Conclusion This investigation is pioneering in establishing a link between intradialytic resistance exercise interventions and prognosis in frail patients. The findings indicate that, although frail patients inherently face a more challenging prognosis, participation in intradialytic exercise can yield substantial improvements. Therefore, clinicians are encouraged to advocate for exercise therapy as a means to enhance prognosis in frail patients undergoing hemodialysis.

The impact of malnutrition on the effectiveness of intradialytic exercise in hemodialysis patients: amulticenter cohort study.

Low physical function can be effectively improved via intradialytic exercise. However, the association between the effects of intradialytic exercise on physical function and malnutrition severity has not been studied extensively. This study aimed to investigate the impact of nutritional status severity on physical function in patients undergoing hemodialysis with low physical function to whom intradialytic exercise was prescribed. The participants were patients with decreased mobility [walking speed < 1.0m/s and/or Short Physical Performance Battery (SPPB) < 12] who had been undergoing hemodialysis thrice a week for 6months and performing intradialytic exercise program. Patients were divided into groups based on the Geriatric Nutritional Risk Index (GNRI) [Non-malnutrition group (GNRI > 98), Gentle/slim malnutrition group (GNRI ≤ 98, GNRI ≥ 92), Mild malnutrition group (GNRI < 92, GNRI ≥ 82), Severe malnutrition group (GNRI < 82)]. The primary outcomes were Grip strength, isometric knee extension strength (IKES), SPPB, and 10-m walking speed measured at baseline and at 6months. Statistical analyses were performed using a linear mixed-effects model with the intention-to-treat analysis, including within-group analysis and between-group comparison. A total of 805 participants were included in the study. Within-group comparisons showed significantly improved IKES, 10-m walking speed, and SPPB improved, except in the Severe malnutrition group. Grip strength significantly improved in the Gentle/slim and mild malnutrition groups. Between-group comparison with controls showed that the improvement in Grip strength was significantly bigger in the Gentle/slim malnutrition group [0.98 (0.15to1.82)kg] than in the non-malnutrition group. However, IKES in the Severe malnutrition group [-5.14 (-9.18 to -1.10) %] less significantly improve than that in the non-malnutrition group. No significant differences were found in the other indices. In patients with severe malnutrition, the changes in IKES scores resulting from Intradialytic exercise were significantly smaller than those observed in non-malnourished patients. Therefore, it is necessary to initiate suitable nutritional and exercise therapy based on the severity of malnutrition.

Effect of Intradialytic Exercise on Cardiovascular Outcomes in Maintenance Hemodialysis: A Systematic Review and Meta-Analysis.

Cardiovascular disease is the leading cause of death among people with kidney failure on hemodialysis, for whom improving cardiovascular health is a research priority. Intradialytic myocardial stunning is common and associated with adverse cardiovascular events. Intradialytic exercise may mitigate intradialytic myocardial stunning and improve cardiovascular structure and function. This systematic review investigated the effect of intradialytic exercise on cardiovascular outcomes in adults undergoing maintenance hemodialysis (PROSPERO #CRD42018103118). Following PRISMA guidelines, we systematically searched MEDLINE, EMBASE, Cochrane CENTRAL, SportDiscus, and PEDro databases from 1960 until June 2022, for randomized and non-randomized studies investigating the effect of intradialytic exercise programs on objective cardiovascular outcomes, pre-specified as primary or secondary outcomes. The primary outcome was arterial resistance. Of 10837 references identified, 32 met eligibility criteria. These studies investigated the effect of intradialytic exercise on arterial resistance (8 studies), blood pressure (20 studies), myocardial structure and function (7 studies), endothelial function (2 studies), sympathetic overactivity (9 studies), biomarkers of cardiac injury (3 studies), cardiovascular hospitalization and mortality (2 studies). Most studies used aerobic exercise as the intervention and usual care (no exercise) controls. Meta-analysis of intradialytic exercise versus usual care resulted in a statistically significant reduction in arterial resistance measured by pulse wave velocity (PWV) with mean difference -1.63 m/sec (95% CI -2.51, -0.75). Meta-analyses for diastolic blood pressure, left ventricular ejection fraction (LVEF), and low-frequency/high-frequency (LF/HF ratio) measure of heart rate variability also showed statistically significant improvements with exercise. There was no significant difference in change in systolic blood pressure, augmentation index, and left ventricular mass index between groups. Intradialytic exercise programming resulted in a clinically meaningful improvement to PWV, a component of arterial resistance. Sseveral physiologic measures of cardiovascular health, including diastolic blood pressure, LVEF and heart rate variability measured by the LF/HF ratio were also observed. The effects of intradialytic exercise on major adverse cardiovascular events remains uncertain.

An intradialytic aerobic exercise program ameliorates frailty and improves dialysis adequacy and quality of life among hemodialysis patients: a randomized controlled trial.

An intradialytic aerobic exercise program ameliorates frailty and improves dialysis adequacy and quality of life among hemodialysis patients: a randomized controlled trial.

A Comprehensive Exercise (COMEX) Intervention to Optimize Exercise Participation for Improving Patient-Centered Outcomes and Physical Functioning in Patients Receiving Hemodialysis: Development and Pilot Testing

To address the need for an intradialytic exercise program that is easily delivered in clinical setting, engaging and scalable, we developed a novel COMprehensive EXercise (COMEX) program based on input from patients receiving hemodialysis (HD), dialysis staff members and nephrologists. The objective of this study was to determine the feasibility, safety, and acceptance of COMEX during HD. Single-arm prospective pilot feasibility study. Seventeen patients receiving in-center HD. Three-month participation in the COMEX program, which included video-based dialysis chair exercises (aerobic and resistance) integrated with educational and motivational components. Data on recruitment, adherence, safety and acceptability were collected. Additional assessments were performed to evaluate changes in physical functioning, patient-reported symptoms, and objectively measured sleep and physical activity. We also examined the feasibility of obtaining skeletal muscle biopsies and blood samples to explore molecular mechanisms of muscle atrophy and to assess platelet mitochondrial function and adaptation to exercise during HD. Thirteen of the 17 (76%) participants completed the 3-month intervention. The mean participant age was 63.6±15.1 years. In total, 46% of participants were males, and 55% were White. The mean body mass index was 38.7±11.6kg/m2. There were no reported adverse effects, and the adherence rate to exercise sessions was high with 88% of the sessions completed. Patient satisfaction was high, as 100% of the patients would recommend the program to other dialysis patients. It was feasible to collect data on physical functioning, patient-reported symptoms, and objective sleep and physical activity and to obtain muscle biopsies and blood samples. Small sample size, lack of an onsite exercise professional, and technological issues with telemedicine behavioral motivation. The COMEX intradialytic exercise intervention is safe and acceptable to patients, and outcome measures were feasible to obtain. Future studies should consider including exercise professionals to facilitate progression through a personalized exercise protocol. This work is supported by pilot award from P30 DK079307 (PI, Jhamb). ClinicalTrials.gov, NCT03055299. We tested a new COMprehensive EXercise (COMEX) program to deliver exercise during dialysis. This 3-month program included video-based dialysis chair exercises (aerobic and resistance) integrated with educational and motivational components. Our study shows COMEX was feasible, had high satisfaction and adherence, and was safe. It was feasible to collect data on physical functioning, patient-reported symptoms, and objective sleep and physical activity and to obtain muscle biopsies and blood samples. Future studies should consider including exercise professionals to facilitate progression through a personalized exercise protocol.

Intradialytic Exercise dan Outcome pada Pasien yang Menjalani Hemodialisis

This study aims to study the effect of intradialysis exercise on patients undergoing hemodialysis. The research method used is a literature search. The research results were published in English and Indonesian journals from 2018 to 2022. The literature search used PICO references in several databases, such as ScienceDirect, ProQuest, Scopus, and PubMed. The results of the study showed that there was a significant effect of intradialysis exercise on improving physical, cognitive, and sleep quality and quality of life. They could help reduce depression levels in patients undergoing hemodialysis. In conclusion, a structured and adequately monitored intradialytic exercise program is the key to the success of an intradialytic exercise program.&#x0D; Keywords: Hemodialysis, Intradialysis Exercise

#5621 BENEFICIAL EFFECTS OF CHRONIC INTRADIALYTIC EXERCISE TRAINING ON HEMODIALYSIS-INDUCED-MYOCARDIAL STUNNING

Abstract Background and Aims Hemodialysis (HD) induces left ventricular (LV) segmental regional wall motion abnormalities (RWMAs) due to hypoperfusion, leading to acute LV transient dysfunction, well known as myocardial stunning. Repeated episodes of HD-related myocardial stunning contribute directly to the development of heart failure and increased mortality in patients receiving HD (Burton et al., 2009). Exercise training exert pleiotropic favorable effects on the cardiovascular system. No study has however investigated its impact on the kinetics of regional myocardial function during HD. This study aims to evaluate the effect of intradialytic exercise (IDE) on RWMAs compared with standard care. Method This was a prospective, open-label, two-center trial (clinicaltrials.gov NCT04697459) with two parallel groups: 31 patients (ENT) undergoing a 4-month IDE program (30min of cycling + 30min of resistance training starting 30 min after HD onset) and 21 patients continuing usual care (CTRL). Untrained adults, aged 20-79 years, undertaking maintenance HD for &amp;gt;3 months were eligible to participate. Exclusion criteria were poor echogenicity, contraindication to exercise, orthopedic complications, severe heart (ischemic, valvular, ...), vascular or respiratory diseases, ejection fraction &amp;lt;45% and body mass index &amp;gt;35. Longitudinal strain (LS) using speckle-tracking echocardiography were measured during a standard HD session, just before HD onset (HDT0) and at peak stress of HD (30 min before HD-ending, HDPeak). The same procedure was used before and after 4-months of IDE or usual care. LS from a 18 LV segment model were used to assess the presence of HD-induced RWMAs, defined as a ≥20% reduction in LS at peak stress compared to baseline. A generalized linear mixed model (Poisson model) was used to analyze the effect of IDE on RWMAs. Results After 4 months of IDE, we observed a significant reduction of RWMAs at HDPeak (mean before: 6.03±3.19 vs after: 4.55±2.26; point estimate: -1.48, 95% confident interval CI: -0.39/-2.57, p = 0.03), whereas its occurrence remained unchanged in CTRL (mean before: 6.14±3.51 vs after: 6.09±3.16; point estimate: -0.05; 95% CI: 1.45/-1.54, p = 0.96). There was also evidence that IDE program significantly attenuated the decline of global LS observed during HD (before: 2.11±2.39% vs after: 1.10±1.95%; point estimate: -1.01%; 95% CI: -1.86/-0.13, p = 0.02) compared to the similar impairment in CTRL (before: 1.60±2.30% vs after: 1.79±2.08%; point estimate: +0.18%; 95% CI: +1.20/-0.85 p = 0.72). Conclusion There is clear evidence that chronic IDE is cardioprotective. Identifying the underlying mechanisms responsible for exercise-induced cardioprotection was beyond the scope of our study, but we can reasonably assume that structural and/or functional changes in the coronary arteries, especially in microcirculatory territories (i.e. increased collateral circulation due to angiogenesis/arteriogenesis, improved endothelial function, reduced blood viscosity) and/or intrinsic changes in the cardiac myocyte (reduced fibrosis, enhanced calcium handling/sensitivity, altered mitochondrial turnover and phenotype), related among others to reduced oxidative stress and/or inflammation, might play a role (Powers et al 2014). Whether our results translate to longer-term reduction in clinical outcomes and cardiovascular mortality in end-stage renal disease patients require further studies.

#3319 GOODRENAL: A FEASIBILITY STUDY OF AN INTRADIALYTIC HOLISTIC VIRTUAL-REALITY PLATFORM

Abstract Background and Aims People with advanced stages of chronic kidney disease (CKD) undergoing hemodialysis often suffer from comorbidities that together with malnutrition and frailty contribute to a sedentary lifestyle, and cognitive and emotional impairments. Intradialytic non-immersive virtual reality exercise programs may improve the health-related quality of life and physical function of people undertaking hemodialysis. The aim of the GoodRENal project was to test the feasibility of an intradialytic holistic virtual-reality platform designed to combine exercise with efforts to improve nutrition and psychological well-being as well as cognitive functioning and to assess the impact on physical, nutritional and psychological variables. Method People undergoing hemodialysis for at least 3 months who were medically stable, from Spain (Hospital de Manises), Sweden (Skane University Hospital and Karolinska Institutet), and Greece (Aristotle University of Thessaloniki) were selected and randomized into the GoodRENal intradialysis intervention group and a control group (usual care). The GoodRENal group was exposed to a platform that consisted of several Virtual Scenarios (games) for each one of the targeted treatment areas: Physical Activity, Nutritional Information, Psychological Well-being and Cognitive Functionality. Specifically, these scenarios (“games”) are aimed to make participants move (Physical Activity), learn aspects related to nutrition that they must follow (Nutritional Information), improve their psychological state (Psychological Well-being), and practice their cognitive abilities (Cognitive Functionality). The interaction with the Virtual Scenarios was designed to minimize “invasive” and “annoying” features by using a depth camera (AZURE Kinect), so that the patient, through the movement of their lower extremities (legs) was able to carry out the interaction. The control group carried out the usual care in the unit. The test battery included physical variables (lower-limb muscle strength, Sit-to-stand to sit test 10 repetitions, 4-meters gait speed, and 6-minute walking test), nutritional variables (short-form food question, 7-point subjective global assessment, body weight, and handgrip strength), psychological variables (depression and anxiety), and cognitive variables. Differences between groups (GoodRENal vs usual care) will be analyzed with a mixed ANOVA model for repeated measures. Results The study so far includes 55 participants (mean age 65.4 ± 13 years), 17 females, median time on hemodialysis 48 months). The program, which starts in 2023, will last 12 weeks, until the middle of May 2023. Conclusion The evaluation of the GoodRENal platform will show if this is a feasible holistic treatment for improving the physical, nutritional, psychological and cognitive condition of people undertaking hemodialysis.

#4416 MAINTAINING PHYSICAL ACTIVITY IN PATIENTS THROUGH INTRADIALYTIC VIRTUAL REALITY EXERCISE INTERVENTION: THE REVID STUDY

Abstract Background and Aims People suffering from Chronic kidney disease (CKD) have lower levels of physical activity than their healthy counterparts. The lower level of physical activity is associated with impaired physical function in people undertaking hemodialysis. The COVID-19 pandemic has worsened the physical activity level of this cohort. Intradialysis exercise programs have a positive impact on many functional variables, but despite these proven benefits exercise interventions are scarce in clinical practice. Our group is implementing strategies to increase clinical applicability of exercise programs. Virtual reality (VR) intradialysis programs improve function of patients. The main aim of this study was to analyze the impact of an intradialytic non-immersive VR exercise program on physical activity level of people undertaking hemodialysis treatment. Methods A randomized trial (the REVID study) included two groups of patients, exercising at different times during the dialysis session for up to 12 months. The present study includes participants from the REVID study who, once the study finished, continued exercising at their preferred time during the hemodialysis treatment, with the only support of the health professionals at the HD unit. Adherence to the exercise program was measured as a percentage (number of sessions attended divided by the number of sessions offered). The physical activity level was evaluated using the Human Activity Profile (HAP) questionnaire. The HAP scale is self-administered and a list of 94 daily activities; the maximal activity score (MAS) and adjusted activity score (AAS) were calculated in this evaluation. Depending on the outcome of the HAP, patients were classified as having physical activity levels that were “impaired” (&amp;lt;53 points), “moderately active” (53–74 points), or “active” (&amp;gt;74 points). These patients had been exercising The intradialytic exercise consisted of a non-immersive VR game called ‘Treasure Hunt’ in which the participant try to catch targets and avoid obstacles by moving their lower limbs (hip flexion, abduction and adduction, and knee flexion and extension). The difficulty level of the game was graduated according to the characteristics of each player and the patients were allowed to change their legs during the game at their convenience. The impact of the program on physical activity level was analyzed with a non-parametric test for paired simples (p&amp;lt;0.05). Results This study included 11 participants, mean age 71.6 (13.9) years, 9 males, median dialysis vintage 18 months (10 to 50 interquartile range), and Charlson index 6.3 (2.2). The AAS at the baseline of the REVID study was 66 (58-72 interquartile range). The median time that participants exercised in the REVID study was 12 months (6 to 18 months interquartile range). After 3 months of the present study, when they exercised at any time during dialysis, they maintained their physical activity level, from a median AAS of 69 (interquartile range 52-71), to a Median of 70 (interquartile range 41-74). The changes were non-significant. The mean adherence to the exercise sessions was 54.6 (11.7)%. Conclusion This study suggests that an intradialysis virtual reality exercise program maintains the physical activity level of elderly patients undertaking HD. Most of the participants in this long-term intervention were male and moderately active. Future interventions should include an ‘exercise champion’ professional in the units to recruit women and les conditioned participants, and to achive higher adherence rates.

#4303 REDUCING FRAILTY IN HEMODIALYSIS PATIENTS THROUGH INTRADIALYTIC VIRTUAL REALITY EXERCISE INTERVENTION: THE REVID STUDY

Abstract Background and Aims People in hemodialysis experience fatigue, weakness, weight loss, exhaustion, and low physical activity - all criteria of the frail phenotype. Frailty is a critical issue in the hemodialysis population due to its link to negative health outcomes, but few studies have focused on frailty in this population, despite the knowledge that frailty can be reversed with early detection and treatment. Our group has previously shown that non-immersive virtual reality exercise during hemodialysis is a safe method to improve physical function and health-related quality of life. The aim of this study is to analyze the impact of an intradialysis non-immersive virtual reality exercise program on frailty in the hemodialysis population. Method A randomized trial (the REVID study) included two groups of patients, exercising at different times during the dialysis session. The present study includes participants from REVID study who, once the study finished, continued exercising at their preferred time during the hemodialysis treatment. All participants were evaluated using the five Fried frailty phenotype criteria: unintentional weight loss of more than 4.5 kg in the past year, exhaustion was assessed using two questions from the Center for Epidemiological Studies Depression (CES-D) scale, weakness was measured using a handgrip dynamometer, walking speed was assessed by timing the 4.6m distance covered at the participant's normal pace, and physical activity was measured using the short version of the Minnesota Leisure Time Physical Activity questionnaire. Each of the five criteria was scored as 0 (not frail-related) or 1 (frail-related). Participants were then stratified into three groups: a score of 0/5 for robust or not frail, a score of 1-2/5 for pre-frail, and a score of 3-5/5 for frail. After the frailty phenotype assessment, all participants performed an intradialytic exercise program consisting of a non-immersive virtual reality game (Treasure Hunting) adapted to the dialysis session. The game consists of catching treasures and avoiding bombs by moving the lower extremities, with a progressive duration of 15 to 45 minutes. Adherence to the exercise program was measured as a percentage (number of sessions attended divided by the number of sessions offered). All assessments and interventions were conducted at Hospital de Manises in Valencia, Spain from September to December 2022. Results The study included 12 subjects with a mean age of 71.8 (13.9) years, 9 of whom were male, median time in Hemodialysis 20 (11.3 - 56 interquartile range) months. Out of the 12 participants, 2 were classified as robust, 5 as pre-frail, and 5 as frail. A chi-square test showed a significant change in the frailty phenotype of the participants after the exercise intervention (15.400; P = 0.003). At the end of the program, 3 participants were classified as frail, 7 as pre-frail, and 2 as robust. 2 participants improved from being frail to pre-frail. Furthermore, five participants (four frail and one pre-frail) reduced the number of criteria associated with the frail phenotype. No worsening in the frailty phenotype was reported among the participants. The average adherence to the exercise program throughout the study was 54.4 (11.2) %. Conclusion This study suggests that an intradialytic exercise program consisting of a non-immersive virtual reality can be useful in mitigating and managing frailty in the hemodialysis population.

Feasibility of randomized controlled trials and long-term implementation of interventions: Insights from a qualitative process evaluation of the PEDAL trial.

A multi-site randomized controlled trial was carried out between 2015 and 2019 to evaluate the impacts on quality of life of an intradialytic exercise programme for people living with chronic kidney disease. This included a qualitative process evaluation which gave valuable insights in relation to feasibility of the trial and of the intervention in the long-term. These can inform future clinical Trial design and evaluation studies. A constructivist phenomenological approach underpinned face-to-face, semi-structured interviews. Purposive recruitment ensured inclusion of participants in different arms of the PEDAL Trial, providers with different roles and trial team members from seven Renal Units in five study regions. Following ethical review, those willing took part in one interview in the Renal Unit. Audio-recorded interviews were transcribed (intelligent verbatim) and inductively thematically analyzed. Participants (n = 65) (Intervention arm: 26% completed; 13% who did not; Usual care arm: 13%; 46% women; 54% men; mean age 60 year) and providers (n = 39) were interviewed (23% PEDAL Trial team members). Three themes emerged: (1) Implementing the Intervention; (2) Implementing the trial; and (3) Engagement of the clinical team. Explanatory theory named "the Ideal Scenario" was developed, illustrating complex interactions between different aspects of intervention and trial implementation with the clinical context. This describes characteristics likely to optimize trial feasibility and intervention sustainability in the long-term. Key aspects of this relate to careful integration of the trial within the clinical context to optimize promotion of the trial in the short-term and engagement and ownership in the long-term. Strong leadership in both the clinical and trial teams is crucial to ensure a proactive and empowering culture. Novel explanatory theory is proposed with relevance for Implementation Science. The "Ideal Scenario" is provided to guide trialists in pre-emptive and ongoing risk analysis relating to trial feasibility and long-term intervention implementation. Alternative study designs should be explored to minimize the research-to-practice gap and optimize the likelihood of informative findings and long-term implementation. These might include Realist Randomized Controlled Trials and Hybrid Effectiveness-Implementation studies.

Effects of a Combined Intradialytic Exercise Training Program on Functional Capacity and Body Composition in Kidney Transplant Candidates.

Chronic kidney disease (CKD) leads to gradual muscle mass loss, which is strongly associated with lower functional capacity, which limits a patient’s daily activities. The aim of the present study is to examine the effects of a 4-month intradialytic exercise program on the functional capacity and body composition of kidney transplant (KT) candidates. Twenty-nine male patients on hemodialysis (HD) waiting for a kidney transplant, with a mean age of 53.86 ± 9.56 years old and BMI 27.11 ± 5.55 kg/m2, were randomly assigned into the following two groups: A (nA = 15 HD patients), who followed a 4-month intradialytic exercise program combining aerobic and resistance training, with a supervised, progressively increasing workload, and B (nB = 14 HD patients), who continued to receive usual care. At baseline and the end of the study, the KT candidates underwent a 6-min walking distance (6-MWD), and a 10-repetition sit-to-stand test (10-STS) to access physical function, a handgrip strength (HGS) test to evaluate the muscle strength of the non-fistula hand. Moreover, the bioelectrical impedance analysis (BIA) was performed to assess body composition indices, such as body fat (BF), body fat mass index (BFMI), fat-free mass index (FFMI), body cell mass (BCM), basal metabolic rate (BMR), extracellular water (ECW), intracellular water (ICW), total body water (TBW) and phase angle (PhA). Following the exercise program, group A showed favorable improvements in HGS (from 26.59 ± 9.23 to 28.61 ± 9.58 kg, p < 0.05) and 6-MWD (from 427.07 ± 7.66 to 468.16 ± 11.39 m, p < 0.05). Intergroup results from 6-MWD showed a statistically significant difference (Δp = 0.04), at the end of the study. Moreover, group A results from BIA revealed a significant increase of BMR by 2.4% (p < 0.05), ECW by 3.6% (p = 0.01), ICW by 3.8% (p = 0.01), TBW by 4.1% (p = 0.01), lean mass by 2.7% (p = 0.01), and PhA by 13.3% (p = 0.04), while a reduction in BF by 5.0% (p = 0.01) and BFMI by 6.6% (p = 0.03) was also noticed. At the end of the study, group A showed statistical differences in BMR (Δp = 0.01), BMR/BW (Δp = 0.01), dry lean (Δp = 0.01), and PhA (Δp = 0.03), compared to the group B. Linear regression analysis in group A after training showed positive correlations between HGS and both PhA (r = 0.52, p = 0.04) and FFMI (r = 0.64, p = 0.01), and a strong negative correlation between 6-MWT and BF (r = −0.61, p = 0.01). In conclusion, a 4-month intradialytic exercise program can enhance body composition and some physical parameters in HD patients awaiting kidney transplantation.

Wiendenbach Theory – Impact of Intradialytic Exercise on Quality of Life of Hemodialysis Patients

Background Chronic kidney disease CKD results in imbalance of fluid electrolytes and acid-base making the body increasingly intoxicated. End stage renal disease ESRD is the last stage of CKD and renal transplant or dialysis is the only management. Dialysis patients face a lot of problems leading to reduction in quality of life QOL.Objective With the advancement in medical technology and healthcare the survival time of patients with CKD is significantly prolonged. However they experience fatigue and poor health-related QOL. This study evaluated the impact of intradialytic exercise program IDEP on QOL of forty hemodialysis patients based on Ernestine Wiedenbachrsquos model.Methodology Forty hemodialysis patients were randomly allocated to control and intervention groups. Subjects in the intervention group performed range of motion and resistance exercises for 25-30 minutes along with routine care whereas control group received only routine care.Results The results of repeated measures ANOVA and independent t test showed that within the intervention group there was a significant improvement in all domains of SF-36 quality of life scale at p lt0.001 indicating that intradialytic exercise was effective. In the control group no such improvement but rather a slight reduction in quality of life score was observed.Conclusion The results demonstrated that intradialytic exercise program was effective in improving quality of life of hemodialysis patients. Therefore it is recommended that according to individual patient capacity inclusion of exercise during dialysis shall reinforce the routine dialysis care.

Profile of professionals working in intradialytic exercise programs in Brazil: a national survey.

This survey was designed to assess the profile of professionals working in intradialytic exercise programs (IEPs) in Brazil and reveal the motivators and barriers they face. The survey was sent to physiotherapists and exercise physiologists working in IEPs in Brazil. Phone interviews and electronic forms were used to collect the answers to the survey questionnaire. Forty-one of the 261 included dialysis centers had IEPs; 44 professionals answered the questionnaire over the phone and 26 used the electronic form to do it. A total of 70 professionals (mean age 33.4±7.4 years; 84.3% physiotherapists) answered the questionnaire. Resistance training was the preferred mode of therapy. Most of the IEPs were connected to research and were paid for by private health insurance. The desire to work in a different field (30.0%) and lack of resources (31.4%) were the most prevalent motivator and barrier cited by IEP professionals working in dialysis centers, respectively. The majority of the few professionals that work in IEPs in Brazil are physiotherapists. Lack of resources was the most commonly reported barrier faced by survey respondents.

Bicycle ergometer exercise during hemodialysis and its impact on quality of life, aerobic fitness and dialysis adequacy: A pilot study

BackgroundChronic kidney disease patients on hemodialysis commonly have a worse quality of life (QoL) due to complications of the disease and dialysis procedure. Physical exercise has emerged as a strategy to improve this scenario. The objective of this study was to evaluate the effect of an intradialytic aerobic exercise program on QoL and aerobic fitness in hemodialysis patients. Material and methodsThese are a secondary analysis of clinical trial data previously published in which hemodialysis patients were randomized into “bike group” (using an adapted exercise bicycle) or “control group” (usual care). The exercise sessions lasted 45 min (5 min of warm-up, 35 min of moderate-intensity and 5 min of cool-down) three times/week for three months. The QoL domains were assessed using the SF-36 QoL questionnaire. Aerobic fitness was evaluated using the 6-min walk test (6MWT). Circulating cytokines, biochemical parameters and Kt/V were also assessed. ResultsNine patients completed three months of exercise (5 men, 44 ± 11 years), and nine were in the control group (6 men, 44 ± 14 years). In the bike group, there was a trend to improve the physical role domain (p = 0.06) regarding QoL, an improvement in the 6MWT (p = 0.02), and in the Kt/V (p = 0.03) after three months. There was a positive correlation between the general health domain and Kt/V (r = 0.691; p = 0.003) and an inverse correlation between the physical functioning domain and plasma TNF-α levels (r = −0.514; p = 0.04). Conclusions12 weeks of intradialytic aerobic exercise was enough to benefit hemodialysis patients' quality of life, aerobic fitness, and quality of dialysis.Clinicaltrials.gov id: NCT04375553.

Effects of a Combined Intradialytic Exercise Training Program and Music on Cardiac Autonomic Nervous System Activity in Hemodialysis Patients.

This study aimed to examine the effect of an intradialytic exercise program in combination with music on heart rate variability (HRV) indices and functional capacity in patients on maintenance hemodialysis (HD). Methods: Forty HD patients were randomized to four training groups for six months: the combined music and exercise group (Group A), the exercise group (Group B), the music group (Group C), and the control group (Group D). At baseline and after 6 months, all participants underwent both short- (for 30 min) and long- (for 24 h) term measurements of HRV and functional capacity assessment with a 6 min walking test (6MWT). Patients of groups A and C listened to preferred music. Results: Long-term HRV analysis showed that standard deviation of all normal-to-normal RR intervals (SDNN) and the square root of the mean squared differences of successive RR intervals (rMSSD) were significantly higher at the end of the study in groups A (by 13.2% and 47.3%), B (by 15.1% and 50%), and C (by 9.0% and 30.1%), compared to group D (p < 0.05). Values of rMSSD and percentage of RR intervals differing by more than 50 ms from the preceding RR interval (pNN50) were elevated in groups A (by 35.6% and 142.9%), B (by 36.1% and 75%), and C (by 15.2% and 28.6%), compared to baseline measurements (p < 0.05). Also, pNN50 was increased in group A compared to groups B (by 21.4%), C (by 88.9%), and D (by 142.9%) (p < 0.05). Similar results were noted by short-term HRV analysis. Functional capacity was improved at the end of the 6-month study in groups A (by 20.3% and 25.7%) and B (by 15.8% and 21.1%) compared to groups C and D (p < 0.05). Conclusions: Intradialytic exercise combined with music-listening can improve the functional capacity and cardiac autonomic nervous system activity in hemodialysis patients.

Effect of intradialytic exercises (IDE) on maximal oxygen consumption and quality of life undergoing hemodialysis in Indian population—a pilot study

BackgroundEnd stage renal disease (ESRD) is emerging as a major health issues across developing countries with limited access and awareness about the importance of exercises in daily life. People on prolong hemodialysis has difficulty in performing their activities of daily living (ADL). Loss of muscle mass is inevitable among patients on hemodialysis that leads to morbidity and mortality. Exercise is feasible during dialysis and can enhance quality of life. Increase in aerobic endurance by various combined protocol of aerobic and resistive exercises can improve compliance to regular exercise that underlines the theme of present study.MethodsA total of 31 participants were recruited during November 2019 to February 2020, after screening of 65 participants for selection criteria from Indraprastha Apollo Hospital’s dialysis unit. The average age of the participants was 52.36 ± 11.56 years. A single-blinded, pre-test–post-test quasi-experimental clinical trial for intradialytic exercise program involving lower limb ergometer and resistance training for lower limbs and non-fistula hand for 24 sessions, in 3 months, twice a week was conducted.ResultsThe exercise program was well tolerated and all patients completed it. Aerobic and resistance intradialytic exercises (IDE) had a positive effect on maximal oxygen consumption (VO2 Max), quality of life (SF 36), and sleep quality (PSQI). IDE showed statistically significant difference from pre- to post-intervention for maximal oxygen consumption, quality of life boosting their sleep quality.ConclusionsIDE found to benefit the patient and results showed a significant improvement in maximal oxygen consumption, sleep quality, quality of life and fatigue over a span of 12 weeks.Trial registrationCTRI, CTRI/2019/08/020848. Registered on 22 August 2019.

Therapeutic Effects of Intradialytic Exercise on Life Quality of Patients with End-Stage Renal Disease: Study Protocol for a Randomized Control Trial.

Background: Exercise training has positive effects on physical functions and could reduce a sedentary lifestyle for hemodialysis (HD) patients. Given that low-level physical activity increases morbidity and mortality, here, we aimed to determine the effects of an intradialytic exercise program delivered at different frequencies on HD patients in Taiwan. Methods: This study is a prospective, randomized control trial. An intradialytic exercise program will be arranged for patients after receiving their informed consent. Patients will be segregated at random into three groups as follows: (a) three times/week of intradialytic exercise training plus standard care maintenance of HD, (b) two times/week of intradialytic exercise training plus standard care maintenance of HD, or (c) standard care maintenance of HD. Subjects will be followed for 24 weeks. At three time points, 0, 12, and 24 weeks, the primary outcome, the Short-Form 36 score, will be measured. Additional secondary outcomes to be measured are the Beck depression inventory, 6 min walking test, sit-to-stand test, and anthropometric measures such as the body mass index, thigh circumference, and the proportion of fat in the body composition. Conclusions: There is emerging evidence in support of intradialytic exercise improving health-related quality of life for patients on HD. However, the difference in the therapeutic effects between three times per week and twice per week has never been determined. With this study, we anticipate to fill the knowledge gap in the exercise prescription among HD patients.

The effect of a 6-month intradialytic exercise program on hemodialysis adequacy and body composition: a randomized controlled trial.

End-stage kidney disease (ESKD) is strongly associated with factors that aggravate the physical activity level and body composition status of hemodialysis patients (HD). Even though exercise in HD patients have shown remarkable benefits on hemodialysis adequacy, it is yet inconclusive if exercise can positively affect body composition parameters or if dialysis adequacy may affect body composition status. This study aimed to investigate the effect of a 6-month intradialytic exercise training program on dialysis adequacy indices and body composition parameters in HD patients. A total of 24 HD patients were randomly assigned into two equally sized groups. The exercise group (EX group) participated in a 6-month intradialytic moderate-intensity aerobic exercise training program at the beginning of the HD sessions, three times a week for 60min, and maintained a Borg's Rating of Perceived Exertion score between 13 and 14. The Control group (C group) remained untrained. At baseline, during, and at the end of the 6-month study, we assessed single-pool Kt/V, urea reduction ratio (URR), and body composition parameters, such as extracellular water (ECW)/ intracellular water (ICW) ratio, body mass index (BMI) and lean tissue mass (LTM). In all patients, the 6-min-walking test (6MWT) was performed as a marker of physical performance. A significant increase of both Kt/V (increase by 19%, p = 0.01), and URR (increase by 7%, p = 0.03) values has been observed in the EX group after the 6-month training program. Similarly, a statistically significant increase in 6MWT distance (from 442 ± 67m to 481 ± 68m, p = 0.02) in the EX group has also been found, compared to the C group (from 393 ± 59m to 427 ± 81m, p = 0.06). Neither EX nor C group has shown significant changes in body composition parameters. After training, linear regression analysis revealed a strong positive correlation between Kt/V and 6MWT changes (r = 0.74, p = 0.04) in the EX group. Six months of intradialytic aerobic exercise might increase dialysis adequacy, by increasing Kt/V and URR, and physical performance, regardless of changes in body composition indices.