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肾脏病患者运动参与度(PACE-KD)研究:肾移植受者可行性研究方案。

Participant acceptability of exercise in kidney disease (PACE-KD): a feasibility study protocol in renal transplant recipients.

机构信息

School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.

John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK.

出版信息

BMJ Open. 2017 Sep 24;7(9):e017494. doi: 10.1136/bmjopen-2017-017494.

DOI:10.1136/bmjopen-2017-017494
PMID:28947458
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5623462/
Abstract

INTRODUCTION

Cardiovascular disease (CVD) is a major cause of mortality in renal transplant recipients (RTRs). General population risk scores for CVD underestimate the risk in patients with chronic kidney disease (CKD) suggesting additional non-traditional factors. Renal transplant recipients also exhibit elevated inflammation and impaired immune function. Exercise has a positive impact on these factors in patients with CKD but there is a lack of rigorous research in RTRs, particularly surrounding the feasibility and acceptability of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) in this population. This study aims to explore the feasibility of three different supervised aerobic exercise programmes in RTRs to guide the design of future large-scale efficacy studies.

METHODS AND ANALYSIS

Renal transplant recipients will be randomised to HIIT A (16 min interval training with 4, 2 and 1 min intervals at 80%-90% of peak oxygen uptake (VO)), HIIT B (4×4 min interval training at 80%-90% VO) or MICT (~40 min cycling at 50%-60% VO) where they will undertake 24 supervised sessions (approximately thrice weekly over 8 weeks). Assessment visits will be at baseline, midtraining, immediate post-training and 3 months post-training. The study will evaluate the feasibility of recruitment, randomisation, retention, assessment procedures and the implementation of the interventions. A further qualitative sub-study QPACE-KD (Qualitative Participant Acceptability of Exercise in Kidney Disease) will explore patient experiences and perspectives through semistructured interviews and focus groups.

ETHICS AND DISSEMINATION

All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, public platforms and academic publications.

TRIAL REGISTRATION NUMBER

Prospectively registered; ISRCTN17122775.

摘要

简介

心血管疾病(CVD)是肾移植受者(RTR)死亡的主要原因。一般人群 CVD 风险评分低估了慢性肾脏病(CKD)患者的风险,表明存在其他非传统因素。肾移植受者也表现出炎症升高和免疫功能受损。运动对 CKD 患者的这些因素有积极影响,但在 RTR 中缺乏严格的研究,特别是在高强度间歇训练(HIIT)与中强度持续训练(MICT)在该人群中的可行性和可接受性方面。本研究旨在探讨三种不同的监督性有氧运动方案在 RTR 中的可行性,以指导未来大规模疗效研究的设计。

方法与分析

肾移植受者将被随机分为 HIIT A(16 分钟间隔训练,4、2 和 1 分钟间隔,峰值摄氧量(VO)的 80%-90%)、HIIT B(4×4 分钟间隔训练,80%-90% VO)或 MICT(~50%-60% VO 时约 40 分钟骑自行车),他们将进行 24 次监督训练(大约每周 3 次,持续 8 周)。评估访问将在基线、训练中期、训练后即刻和 3 个月后进行。该研究将评估招募、随机化、保留、评估程序和干预措施的实施的可行性。一项进一步的定性子研究 QPACE-KD(肾脏病患者运动的定性参与者可接受性)将通过半结构式访谈和焦点小组探讨患者的经验和观点。

伦理与传播

已获得所有必需的伦理和监管批准。研究结果将通过会议演讲、公共平台和学术出版物进行传播。

试验注册号

前瞻性注册;ISRCTN85553617。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/12c02e504737/bmjopen-2017-017494f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/285ffc1a11e5/bmjopen-2017-017494f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/e7c08b1484d2/bmjopen-2017-017494f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/12c02e504737/bmjopen-2017-017494f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/285ffc1a11e5/bmjopen-2017-017494f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/e7c08b1484d2/bmjopen-2017-017494f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5a7/5623462/12c02e504737/bmjopen-2017-017494f03.jpg

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