Clinical trial NCT04455919: Yoga for Chronic Chikungunya
Official title: Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chikungunya Virus Infection
Keywords: chikungunya virus
yoga
chronic chikungunya
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized wait-list controlled design
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Health Related Quality of Life - Short Form-36 (SF-36)
timeFrame: At baseline
measure: Health Related Quality of Life - Short Form-36 (SF-36)
timeFrame: after 8 weeks of intervention
measure: Health Related Quality of Life - Short Form-36 (SF-36)
timeFrame: after 18 weeks
Secondary outcomes:
measure: nociceptive pain - Visual Analog Scale (VAS)
timeFrame: At baseline
measure: nociceptive pain - Visual Analog Scale (VAS)
timeFrame: after 8 weeks of intervention
measure: nociceptive pain - Visual Analog Scale (VAS)
timeFrame: after 18 weeks
measure: neuropathic pain- DN4 scale
timeFrame: At baseline
measure: neuropathic pain- DN4 scale
timeFrame: after 8 weeks of intervention
measure: neuropathic pain- DN4 scale
timeFrame: after 18 weeks
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: Mouffias' Medical Center in Guadeloupe.
Study officials:
References: