The PrEscription of intraDialytic exercise to improve quAlity of Life in patients with chronic kidney disease trial: study design and baseline data for a multicentre randomized controlled trial

Abstract

Background Exercise 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. Methods We 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. Results At 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. Conclusion The 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 Registration ISRCTN N83508514; registered on 17 December 2014.

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

“…The trial protocol and details on inclusion/exclusion criteria, randomization procedure, and exercise intervention and prescription have been described elsewhere. 26 The Consolidated Standards of Reporting Trials Extension for Patient Report Outcomes also suggested reporting all the multi-item scales from the KDQOL-SF instrument.…”

“…Upper limits of exercise tolerance were assessed by peak oxygen uptake determined by an incremental cycling protocol. 26 Physical function limitations were assessed by the sit-to-stand-60 30 and gait speed in 10 m. 31 Physical activity behaviors were captured by the International Physical Activity Questionnaire Short-Form 32 ; ability to undertake activities of daily livings was recorded by the Duke Activity Status Index 33 ; and fear of falling was assessed by the Tinetti Falls Efficacy Scale. 34 …”

Does the interference phenomenon affect strength development during same‐session combined rehabilitation program in hemodialysis patients?

“…57,58 In a study of Greenwood et al, authors reported an improvement of quality of life on a cohort of 355 HD patients with a median age of 59.3 years. 59 It is also documented that the benefit of strength training is greatest in frail elderly than elderly. [60][61][62] However, in a retrospective study conducted on older HD patients (>60 years), Imamura et al found that intradialytic lowintensity resistance training did not improve physical activity and physical function.…”

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

“…The timings of the outcome measurements will be set according to past studies on intradialytic exercise. Some of them measured the results after 3 months of intradialytic exercise [ 13 , 14 , 15 ], while others were evaluated 6 months later [ 11 , 16 ].…”

“…In the United Kingdom (UK), structured exercise interventions, mostly delivered by a cycle ergometer during HD at medical centers, have shown clinical benefits in patients. These were also shown to improve HD adequacy, have anti-depressive effects, cost-effective outcomes, and improve quality of life in these British patients [ 11 , 12 ].…”