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
Jyoti Singh , Monika Jha , Kashinath Metri , Sriloy Mohanty , Amit Singh , Padmini Tekur
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引用次数: 3
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)
期刊介绍：
Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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