Dataset Information

Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis.

ABSTRACT:

Introduction

Whether clinically implementable exercise interventions in people receiving hemodialysis (HD) therapy improve health-related quality of life (HRQoL) remains unknown. The PrEscription of intraDialytic exercise to improve quAlity of Life (PEDAL) study evaluated the clinical benefit and cost-effectiveness of a 6-month intradialytic exercise program.

Methods

In a multicenter, single-blinded, randomized, controlled trial, people receiving HD were randomly assigned to (i) intradialytic exercise training (exercise intervention group [EX]) and (ii) usual care (control group [CON]). Primary outcome was change in Kidney Disease Quality of Life Short-Form Physical Component Summary (KDQOL-SF 1.3 PCS) from baseline to 6 months. Cost-effectiveness was determined using health economic analysis; physiological impairment was evaluated by peak oxygen uptake; and harms were recorded.

Results

We randomized 379 participants; 335 and 243 patients (EX n = 127; CON n = 116) completed baseline and 6-month assessments, respectively. Mean difference in change PCS from baseline to 6 months between EX and CON was 2.4 (95% confidence interval [CI]: -0.1 to 4.8) arbitrary units (P = 0.055); no improvements were observed in peak oxygen uptake or secondary outcome measures. Participants in the intervention group had poor compliance (47%) and poor adherence (18%) to the exercise prescription. Cost of delivering intervention ranged from US$598 to US$1092 per participant per year. The number of participants with harms was similar between EX (n = 69) and CON (n = 56). A primary limitation was the lack of an attention CON. Many patients also withdrew from the study or were too unwell to complete all physiological outcome assessments.

Conclusions

A 6-month intradialytic aerobic exercise program was not clinically beneficial in improving HRQoL as delivered to this cohort of deconditioned patients on HD.

SUBMITTER: Greenwood SA

PROVIDER: S-EPMC8343798 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis.

Greenwood Sharlene A SA Koufaki Pelagia P Macdonald Jamie H JH Bhandari Sunil S Burton James O JO Dasgupta Indranil I Farrington Kenneth K Ford Ian I Kalra Philip A PA Kean Sharon S Kumwenda Mick M Macdougall Iain C IC Messow Claudia-Martina CM Mitra Sandip S Reid Chante C Smith Alice C AC Taal Maarten W MW Thomson Peter C PC Wheeler David C DC White Claire C Yaqoob Magdi M Mercer Thomas H TH

Kidney international reports 20210530 8

<h4>Introduction</h4>Whether clinically implementable exercise interventions in people receiving hemodialysis (HD) therapy improve health-related quality of life (HRQoL) remains unknown. The PrEscription of intraDialytic exercise to improve quAlity of Life <b>(</b>PEDAL) study evaluated the clinical benefit and cost-effectiveness of a 6-month intradialytic exercise program.<h4>Methods</h4>In a multicenter, single-blinded, randomized, controlled trial, people receiving HD were randomly assigned t ...[more]

PMID: 34386665

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Project description:BackgroundExercise interventions designed to improve physical function and reduce sedentary behaviour in haemodialysis (HD) patients might improve exercise capacity, reduce fatigue and lead to improved quality of life (QOL). The PrEscription of intraDialytic exercise to improve quAlity of Life study aimed to evaluate the effectiveness of a 6-month intradialytic exercise programme on QOL and physical function, compared with usual care for patients on HD in the UK.MethodsWe conducted a prospective, pragmatic multicentre randomized controlled trial in 335 HD patients and randomly (1:1) assigned them to either (i) intradialytic exercise training plus usual care maintenance HD or (ii) usual care maintenance HD. The primary outcome of the study was the change in Kidney Disease Quality of Life Short Form (KDQOL-SF 1.3) Physical Component Score between baseline and 6 months. Additional secondary outcomes included changes in peak aerobic capacity, physical fitness, habitual physical activity levels and falls (International Physical Activity Questionnaire, Duke's Activity Status Index and Tinetti Falls Efficacy Scale), QOL and symptom burden assessments (EQ5D), arterial stiffness (pulse wave velocity), anthropometric measures, resting blood pressure, clinical chemistry, safety and harms associated with the intervention, hospitalizations and cost-effectiveness. A nested qualitative study investigated the experience and acceptability of the intervention for both participants and members of the renal health care team.ResultsAt baseline assessment, 62.4% of the randomized cohort were male, the median age was 59.3 years and 50.4% were white. Prior cerebrovascular events and myocardial infarction were present in 8 and 12% of the cohort, respectively, 77.9% of patients had hypertension and 39.4% had diabetes. Baseline clinical characteristics and laboratory data for the randomized cohort were generally concordant with data from the UK Renal Registry.ConclusionThe results from this study will address a significant knowledge gap in the prescription of exercise interventions for patients receiving maintenance HD therapy and inform the development of intradialytic exercise programmes both nationally and internationally.Trial registrationISRCTN N83508514; registered on 17 December 2014.

Project description:BackgroundHealth-related quality of life (HRQOL) reflects a patient's perceived disease burden, treatment effectiveness, and health status. Given the time burden and physiologic effects of hemodialysis, patients who spend dialysis time (9-15 h/week) physically or intellectually engaged may have better HRQOL. We characterized the intradialytic activities and explored their association with HRQOL.MethodsIn a cross-sectional study of 431 hemodialysis patients, we ascertained kidney-disease-specific quality of life, measured frailty, and surveyed participants about their usual active intradialytic activities (reading, playing games, doing puzzles, chatting, or other) and passive intradialytic activities (watching TV or sleeping). We used adjusted ordered logistic regression to identify correlates of the activity index (the sum of active intradialytic activities) and adjusted linear regression to quantify the association between the activity index and physical-, mental-, and kidney-disease-specific HRQOL.ResultsThe 2 most common intradialytic activities were passive activities (watching TV = 87.9%; sleeping = 72.4%). Participants who were female (aOR 1.85, 95% CI 1.28-2.66; p = 0.001), nonfrail (aOR 1.70, 95% CI 1.06-2.70; p = 0.03), and nonsmokers (aOR 2.61, 95% CI 1.39-4.90; p = 0.003) had a higher intradialytic activity index after adjustment. Higher intradialytic activity index was associated with better mental- (0.83 points, 95% CI 0.04-1.62; p = 0.04) and kidney-disease-specific HRQOL (1.70 points, 95% CI 0.47-2.93; p = 0.007), but not physical HRQOL.ConclusionsHemodialysis patients with more active intradialytic activities report better mental and kidney-disease-specific HRQOL. These results should be confirmed in a prospective study with a broader cohort of hemodialysis patients. Dialysis providers may consider offering patients with low levels of activity additional support and opportunities to engage in beneficial intradialytic activities.

Project description:Most patients with end-stage kidney disease value their health-related quality of life (HRQoL) and want to know how it will be affected by their dialysis modality. We extended the findings of two prior clinical trial reports to estimate the effects of frequent compared to conventional hemodialysis on additional measures of HRQoL. The Daily Trial randomly assigned 245 patients to receive frequent (six times per week) or conventional (three times per week) in-center hemodialysis. The Nocturnal Trial randomly assigned 87 patients to receive frequent nocturnal (six times per week) or conventional (three times per week) home hemodialysis. All patients were on conventional hemodialysis prior to randomization, with an average feeling thermometer score of 70 to 75 (a visual analog scale from 0 to 100 where 100 is perfect health), an average general health scale score of 40 to 47 (a score from 0 to 100 where 100 is perfect health), and an average dialysis session recovery time of 2 to 3 hours. Outcomes are reported as the between-treatment group differences in one-year change in HRQoL measures and analyzed using linear mixed effects models. After one year in the Daily Trial, patients assigned to frequent in-center hemodialysis reported a higher feeling thermometer score, better general health, and a shorter recovery time after a dialysis session compared to standard thrice-weekly dialysis. After one year in the Nocturnal Trial, patients assigned to frequent home hemodialysis also reported a shorter recovery time after a dialysis session, but no statistical difference in their feeling thermometer or general health scores compared to standard home dialysis schedules. Thus, patients receiving day or nocturnal hemodialysis on average recovered approximately one hour earlier from a frequent compared to conventional hemodialysis session. Patients treated in an in-center dialysis facility reported better HRQoL with frequent compared to conventional hemodialysis.

Project description:The prevalence of cognitive impairment in hemodialysis (HD) patients is extremely high. Despite the well-documented benefits of interventions on cognitive function, there is a widespread call for effective strategies that will show the long-term consequences in patients undergoing dialysis. The aim of this research protocol was to investigate the effect of cognitive training combined with physical exercise on cognitive function, physical performance, and frailty indicators in the HD population. We will conduct a randomized controlled intervention trial to examine the effects of a combined non-pharmacological intervention in the form of intradialytic physical exercise and intradialytic cognitive training on cognitive function, indicators of frailty, and physical performance measures in HD patients. The group of patients receiving the study intervention will be compared to the control group receiving standard HD care. The duration of the intervention will be 12 weeks. We will use sensitive instruments (cognitive domain tests) to assess cognitive functions. The primary outcome of the study at 12 weeks will be performance on the Alertness subtest of the computerized Test of Attentional Performance. Secondary study outcomes are: Performance in other domains of cognitive function (executive function, psychomotor speed, information processing efficiency, working memory, and attention), physical fitness (10 repetition sit-to-stand test, timed up and go test, handgrip strength test, spontaneous gait speed, and stork balance test), and assessment of frailty (Edmonton Frail Scale). Study outcomes will be assessed at baseline, immediately after the 12-week intervention, and 6 months after the end of the study without specific further intervention (retention effect assessment). This study will be among the first to test the synergistic effects of a uniquely designed physical exercise and cognitive training intervention on functional status in HD patients. We believe our results will contribute to dementia prevention research by demonstrating the long-term efficacy of our combined intervention. Clinical Trial Registration: ClinicalTrials.Gov, NCT05150444.

Dataset Information

Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis.

Introduction

Methods

Results

Conclusions

Publications

Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis.

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