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一项关于在新冠疫情期间瑜伽作为强直性脊柱炎患者辅助治疗疗效的随机对照试验的研究方案。

A study protocol for a randomised controlled trial on the efficacy of yoga as an adjuvant therapy for patients with Ankylosing spondylitis amidst COVID-19 pandemic.

作者信息

Singh Jyoti, Jha Monika, Metri Kashinath, Mohanty Sriloy, Singh Amit, Tekur Padmini

机构信息

Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA Yoga University), Bengaluru, Karnataka, India.

Centre for Integrative Medicine and Research, All India Institute of Medical Science, New Delhi, India.

出版信息

Adv Integr Med. 2022 Mar;9(1):75-79. doi: 10.1016/j.aimed.2021.11.001. Epub 2021 Nov 21.

DOI:10.1016/j.aimed.2021.11.001
PMID:34840945
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8606184/
Abstract

BACKGROUND

Amidst the adversities of the COVID-19 pandemic, the health care system has seen a new paradigm shift towards e-health or telehealth services. In the advent of catering to the geometrically increasing health care needs of the patients suffering from various chronic health conditions when in social isolation, the need for such shifts is paramount. Patients with Ankylosing spondylitis using immunosuppressants with variable degrees of disabilities are at higher risk from this isolated status. This study aims to assess the efficacy of e-Yoga as a treatment option for these patients.

METHODS

The proposed study is a single-center, parallel-group prospective randomized, open-blinded end-point trial. Patients aged between 30 and 50 years will be recruited from the members of Antardhwani: A society of ankylosing spondylitis based in Ahmedabad, Gujarat. Yoga experts will administer a scientifically developed and validated Yoga module via e-Yoga modalities. A total of 135 patients will be recruited and randomly allocated to Yoga and control groups. Data will be recorded at baseline and three months on disease activity, degree of functional limitations in patients, quality of life, inflammatory biomarkers, depression, and anxiety using Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index BASFI), AS Quality of Life index ASQOL), C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Physical health questionnaire-4 (PHQ-4), respectively.

DISCUSSION

The study will report the efficacy of e-Yoga in catering to the physical and mental insufficiencies of inpatients with Ankylosing spondylitis amidst COVID-19 pandemic. The study is prospectively registered in the Clinical Trial Registry of India (CTRI/2020/08/027215).

摘要

背景

在新冠疫情的逆境中,医疗保健系统已朝着电子健康或远程医疗服务发生了新的范式转变。在社会隔离期间,为满足患有各种慢性健康状况的患者几何级数增长的医疗保健需求,这种转变的必要性至关重要。使用免疫抑制剂且有不同程度残疾的强直性脊柱炎患者因这种隔离状态面临更高风险。本研究旨在评估电子瑜伽作为这些患者治疗选择的疗效。

方法

拟进行的研究是一项单中心、平行组前瞻性随机、开放盲法终点试验。将从古吉拉特邦艾哈迈达巴德的强直性脊柱炎协会Antardhwani的成员中招募年龄在30至50岁之间的患者。瑜伽专家将通过电子瑜伽方式实施科学开发并验证的瑜伽模块。总共将招募135名患者并随机分配到瑜伽组和对照组。将分别使用巴斯强直性脊柱炎疾病活动指数(BASDAI)、巴斯强直性脊柱炎功能指数(BASFI)、强直性脊柱炎生活质量指数(ASQOL)、C反应蛋白(CRP)、红细胞沉降率(ESR)、身体健康问卷-4(PHQ-4)在基线和三个月时记录疾病活动度、患者功能受限程度、生活质量、炎症生物标志物、抑郁和焦虑情况。

讨论

该研究将报告在新冠疫情期间电子瑜伽在满足强直性脊柱炎住院患者身心不足方面的疗效。该研究已在印度临床试验注册中心(CTRI/2020/08/027215)进行前瞻性注册。

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