跳至主要内容
临床试验/NCT04455919
NCT04455919终止不适用

Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study

Centre Hospitalier Universitaire de Pointe-a-Pitre2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
42
试验地点
2
主要终点
Health Related Quality of Life - Short Form-36 (SF-36)

研究概览

简要总结

The purpose of this study is to assess the benefits of a 8-week yoga program on quality of life in patients suffering from chronic chikungunya.

Studies have already shown the effectiveness of yoga practice on various arthralgia's, on the reduction of inflammatory reactions, on psychological disorders/sleep disorders and on quality of life. Considering quality of life as a global experience of balance between physical and mental wellbeing, the hypothesis was that the practice of yoga would globally improve the quality of life of patients with chronic chikungunya.

详细描述

The chikungunya virus (CHIKV) is an arbovirus passed to humans by Aedes mosquitoes. Since its description in 1952, CHIKV has caused millions of human infections in Africa, the Indian Ocean islands, Asia, Europe and America (1). In total, since 2013, the epidemic has affected more than 2 million people in the Americas. In Guadeloupe, the emergence of chikungunya cases began in 2013. CHINKV was declared an epidemic in 2014 with an estimated 20,000 infected patients.Human infection with CHIKV is characterized by a sudden onset of severe joint pains, high fever and rash. The infection is self-limited and acute symptoms usually disappear within one or two weeks. However, this polyarthralgia is recurrent in 30 to 40% of infected people and can persist for years. Chikungunya is considered chronic if the symptoms persist after three months. The chronic stage can last from a few months to several years. Chronic chikungunya usually manifests as joint pain and stiffness, polyarthralgia (including rheumatoid arthritis, flare-ups of spondylitis), and other general symptoms such as intermittent headaches, edema, and paresthesia. The consequences of chronic CHIKV can be severe, with patients becoming maladjusted to their lifestyle, feeling weakened and diminished. Depression and medical leaves are very frequent, with many cases of disability. Yoga is an ancestral Indian practice aiming to connect the "body" and the "soul", the "self" and "the other". Traditionally, it is a philosophical way of living, sometimes combined with the practice of physical exercises. In westernized countries, Yoga is usually considered as a physical practice or an alternative therapy, using various techniques of breathing, relaxation and poses to release tensions and decrease pain.

Studies have already shown the effectiveness of yoga practice on various arthralgia's, on the reduction of inflammatory reactions, on psychological disorders/sleep disorders and on quality of life. Considering quality of life as a global experience of balance between physical and mental wellbeing, the hypothesis was that the practice of yoga, by improving these different aspects, would globally improve the quality of life of patients with chronic chikungunya.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from chronic chikungunya, as documented by a positive chikungunya serology and the following symptoms: polyarthralgia and/or musculoskeletal disorder and/or morning stiffness.
  • Patients had to be between 18 and 70 years old, and be
  • patients affiliated to the French social insurance.

排除标准

  • being pregnant;
  • suffering from pre-existing rheumatic diseases before the Chikungunya infection;
  • showing acute symptoms of a Chikungunya infection (documented serology);
  • being unable to practice yoga poses ; having been recently treated with methotrexate or corticosteroids (less than 3 months ago);
  • being under guardianship, trusteeship or legal protection,
  • participating in another research study,
  • showing severely impaired physical and/or psychological health, which in the opinion of the investigator, may affect the compliance of the study participant.

结局指标

主要结局

Health Related Quality of Life - Short Form-36 (SF-36)

时间窗: after 18 weeks

This scale measures eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health) of quality of life for adults aged 18 and older. Using a scoring algorithm, the aggregated scores can provide two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score.

次要结局

  • neuropathic pain- DN4 scale(after 18 weeks)
  • nociceptive pain - Visual Analog Scale (VAS)(after 18 weeks)

研究者

发起方
Centre Hospitalier Universitaire de Pointe-a-Pitre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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