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Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: The proposed randomized controlled trial protocol will evaluate the effect of acupuncture treatment on the functional capacity (FC) and health-related quality of life (HRQOL) in chronic kidney disease (CKD) with glomerular filtration rate (GFR) category 5 (CKG G5) patients receiving maintenance dialysis. Patients undergoing hemodialysis (HD) from a dialysis center will be randomly assigned to experimental, placebo and control groups. In order to determine the difference between the same number of treatments performed three times or one treatment a week, experimental (verum acupuncture) and placebo (sham acupuncture) groups will receive a total of nine acupuncture treatments; however, both groups will be divided into subgroups A and B. The same selection of acupuncture points will be applied to both experimental subgroups and the placebo subgroups will receive acupuncture on non-acupuncture points. The results will be assessed by the 6-min Walk Test, Handgrip Test, 30-sec Sit-to-Stand and Kidney Disease Quality of Life-Short Form and will be held at baseline, after treatment and 12 weeks post-treatment follow up. This paper describes the rationale and design for a randomized, patient-assessor blinded controlled trial, which may provide evidence for the clinical application of acupuncture in CKG G5 patients undergoing HD.

SUBMITTER: Correia de Carvalho M

PROVIDER: S-EPMC9602343 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial.

Correia de Carvalho Marta M Pereira Machado Jorge J Laranjeira Manuel M Nunes de Azevedo José J Azevedo Pedro P

Healthcare (Basel, Switzerland) 20221017 10

The proposed randomized controlled trial protocol will evaluate the effect of acupuncture treatment on the functional capacity (FC) and health-related quality of life (HRQOL) in chronic kidney disease (CKD) with glomerular filtration rate (GFR) category 5 (CKG G5) patients receiving maintenance dialysis. Patients undergoing hemodialysis (HD) from a dialysis center will be randomly assigned to experimental, placebo and control groups. In order to determine the difference between the same number o ...[more]

PMID: 36292497

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Project description:IntroductionAtrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived inadequate control of AF may diminish the QoL for some patients, potentially even to levels lower than pre-procedure. Preliminary findings from our previous pilot trial indicate that acupuncture may positively influence QoL in AF patients post-CA. This study aims to increase the sample size to evaluate the efficacy of acupuncture as an adjunctive treatment to conventional medical therapy in improving QoL of patients with AF after CA.Methods and designThis multicentre randomised clinical trial will be conducted in China. A total of 146 eligible patients will be randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. All patients will receive standard postablation care and undergo 18 sessions of acupuncture/sham acupuncture within 12 weeks following CA, followed by a 9-month follow-up period. The primary outcome is the change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) summary score from baseline to months 6 after CA. Secondary outcomes include the changes in the AFEQT subscale scores at months 6, the AFEQT summary and subscale score at months 3 and 12, AF burden, AF recurrence, heart rate variability, number of cardioversions, repeat CA procedures, European Heart Rhythm Association score, number of arrhythmia-related hospitalisations, average heart rate, use of Six-Dimensional Health State Short Form to assess health status, costs incurred by disease treatment, Credibility/Expectancy Questionnaire and blinded assessments. Adverse events will also be meticulously recorded throughout the trial.Ethics and disseminationEthics approval has been granted by the Ethics Committee of Beijing University of Traditional Chinese Medicine (approval no: 2020BZYLL0802) and seven other subcentres. The findings of the study results will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.Trial registration numberChiCTR2100049323.

Dataset Information

Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial.

Publications

Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial.

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