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
Autor: | Sunil Bhandari, Ken Farrington, Alice C. Smith, Chante Reid, Sharon Kean, Claire White, David C. Wheeler, Maarten W. Taal, Thomas H. Mercer, Sandip Mitra, Jamie H. Macdonald, Philip A. Kalra, Claudia-Martina Messow, James O. Burton, Pelagia Koufaki, Ian Ford, Iain C. Macdougall, Indranil Dasgupta, Sharlene A. Greenwood, Mick Kumwenda, Magdi Yaqoob, Peter C. Thomson |
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Rok vydání: | 2020 |
Předmět: |
Transplantation
medicine.medical_specialty business.industry Tinetti test Physical fitness 030232 urology & nephrology 030204 cardiovascular system & hematology Anthropometry medicine.disease law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life Nephrology law Cohort medicine Physical therapy Medical prescription business Kidney disease |
Zdroj: | Clinical Kidney Journal. 14:1345-1355 |
ISSN: | 2048-8513 |
Popis: | 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. |
Databáze: | OpenAIRE |
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