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运动康复对接受造血干细胞移植的再生障碍性贫血患者的疗效:一项随机对照试验的研究方案。

Effectiveness of exercise rehabilitation on aplastic anemia patients receiving hematopoietic stem cell transplantation: study protocol for a randomized controlled trial.

机构信息

Department of Hematology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.

The College of Nursing, Zhejiang Chinese Medical University, Hangzhou, China.

出版信息

Trials. 2024 Jun 5;25(1):361. doi: 10.1186/s13063-024-08197-4.

Abstract

BACKGROUND

Although hematopoietic stem cell transplantation provides the chances of survival for aplastic anemia patients, it is also related to many treatment-related physical and psychological side effects that severely influence the quality of life. Exercise interventions have shown positive results in mixed hematology populations. The study aims to determine the effectiveness of exercise rehabilitation in improving the quality of life, fatigue, and physical function in these patients.

METHODS

The study will enroll a total of 82 aplastic anemia patients receiving hematopoietic stem cell transplantation. They will be randomly divided into two groups in a 1:1 ratio. The intervention group will participate in structured exercise rehabilitation (plus usual care), while control group participants will receive usual care. The exercise rehabilitation program will be performed from neutrophil and platelet engraftment until 100 days after transplantation. All outcomes will be measured at the following time points: the neutrophil and platelet engraftment (± 1day, T0), discharge from the transplantation module (± 1 day, T1), hospital discharge (± 1 day, T2), and 100 days post-transplantation (± 5 days, T3).

DISCUSSION

This study aims to assess the effectiveness of exercise rehabilitation for aplastic anemia patients receiving hematopoietic stem cell transplantation in a Chinese single center. It is particularly vital to conduct the studies in this population. Moreover, the evidence obtained from the study will provide evidence for future research and clinical practice to exercise in aplastic anemia patients.

TRIAL REGISTRATION

ChiCTR2200060762. Registered on May 2022, www.trialregister.nl/trial/7702.

摘要

背景

造血干细胞移植为再生障碍性贫血患者提供了生存机会,但也与许多治疗相关的身体和心理副作用有关,严重影响生活质量。运动干预在混合血液学人群中已显示出积极的结果。本研究旨在确定运动康复在改善这些患者的生活质量、疲劳和身体功能方面的有效性。

方法

本研究将纳入 82 名接受造血干细胞移植的再生障碍性贫血患者。他们将以 1:1 的比例随机分为两组。干预组将参加结构化的运动康复(加常规护理),而对照组参与者将接受常规护理。运动康复计划将从中性粒细胞和血小板植入开始,持续到移植后 100 天。所有结果将在以下时间点进行测量:中性粒细胞和血小板植入(±1 天,T0)、移植模块出院(±1 天,T1)、医院出院(±1 天,T2)和移植后 100 天(±5 天,T3)。

讨论

本研究旨在评估运动康复对在中国单一中心接受造血干细胞移植的再生障碍性贫血患者的有效性。在该人群中进行研究尤为重要。此外,该研究获得的证据将为未来的研究和临床实践提供在再生障碍性贫血患者中运动的证据。

试验注册

ChiCTR2200060762。2022 年 5 月注册,www.trialregister.nl/trial/7702。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c141/11151474/e87d875b0254/13063_2024_8197_Fig1_HTML.jpg

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