Yoga for Chronic Chikungunya (YOCHIK)

• ClinicalTrials.gov Identifier: NCT04455919
• Recruitment Status: Terminated
• First Posted: July 2, 2020
• Last Update Posted: July 2, 2020
• Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Pointe-a-Pitre

Tracking Information

• First Submitted Date: June 29, 2020
• First Posted Date: July 2, 2020
• Last Update Posted Date: July 2, 2020
• Actual Study Start Date: October 3, 2019
• Actual Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 1, 2020)

• Health Related Quality of Life - Short Form-36 (SF-36) [ Time Frame: At baseline ]
  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.
• Health Related Quality of Life - Short Form-36 (SF-36) [ Time Frame: after 8 weeks of intervention ]
  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.
• Health Related Quality of Life - Short Form-36 (SF-36) [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 1, 2020)

• nociceptive pain - Visual Analog Scale (VAS) [ Time Frame: At baseline ]
  The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
• nociceptive pain - Visual Analog Scale (VAS) [ Time Frame: after 8 weeks of intervention ]
  The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
• nociceptive pain - Visual Analog Scale (VAS) [ Time Frame: after 18 weeks ]
  The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no pain" anchor point.
• neuropathic pain- DN4 scale [ Time Frame: At baseline ]
  The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
• neuropathic pain- DN4 scale [ Time Frame: after 8 weeks of intervention ]
  The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
• neuropathic pain- DN4 scale [ Time Frame: after 18 weeks ]
  The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Yoga for Chronic Chikungunya
• Official Title: Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

randomized wait-list controlled design

Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care

• Condition: Chikungunya Virus Infection

Intervention

• Other: Wait-list group
  The wait-list group benefit from a 8-week yoga program after the interventional group
• Other: Yoga group
  During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home

Study Arms

• Experimental: Yoga
  Yoga classes once a week for eight weeks
  Intervention: Other: Yoga group
• Wait-list control
  The delayed intervention group was to benefit from the intervention after week 8.
  Intervention: Other: Wait-list group

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 1, 2020): 42
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 30, 2020
• Actual Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Guadeloupe

Administrative Information

• NCT Number: NCT04455919
• Other Study ID Numbers: PAP/RI2/2019_05; 2019-A01632-55 ( Other Identifier: ANSM )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Verification Date: July 2020