Yoga for Chronic Chikungunya (YOCHIK)
Primary Purpose
Chikungunya Virus Infection
Status
Terminated
Phase
Not Applicable
Locations
Guadeloupe
Study Type
Interventional
Intervention
Wait-list group
Yoga group
Sponsored by
About this trial
This is an interventional supportive care trial for Chikungunya Virus Infection focused on measuring chikungunya virus, yoga, 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.
Sites / Locations
- Mouffias' Medical Center in Guadeloupe.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Yoga
Wait-list control
Arm Description
Yoga classes once a week for eight weeks
The delayed intervention group was to benefit from the intervention after week 8.
Outcomes
Primary Outcome Measures
Health Related Quality of Life - Short Form-36 (SF-36)
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)
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)
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.
Secondary Outcome Measures
nociceptive pain - Visual Analog Scale (VAS)
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)
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)
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
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
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
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.
Full Information
NCT ID
NCT04455919
First Posted
June 29, 2020
Last Updated
July 1, 2020
Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
1. Study Identification
Unique Protocol Identification Number
NCT04455919
Brief Title
Yoga for Chronic Chikungunya
Acronym
YOCHIK
Official Title
Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
covid health crisis
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus Infection
Keywords
chikungunya virus, yoga, chronic chikungunya
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized wait-list controlled design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Description
Yoga classes once a week for eight weeks
Arm Title
Wait-list control
Arm Type
Other
Arm Description
The delayed intervention group was to benefit from the intervention after week 8.
Intervention Type
Other
Intervention Name(s)
Wait-list group
Intervention Description
The wait-list group benefit from a 8-week yoga program after the interventional group
Intervention Type
Other
Intervention Name(s)
Yoga group
Intervention Description
During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home
Primary Outcome Measure Information:
Title
Health Related Quality of Life - Short Form-36 (SF-36)
Description
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.
Time Frame
At baseline
Title
Health Related Quality of Life - Short Form-36 (SF-36)
Description
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.
Time Frame
after 8 weeks of intervention
Title
Health Related Quality of Life - Short Form-36 (SF-36)
Description
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.
Time Frame
after 18 weeks
Secondary Outcome Measure Information:
Title
nociceptive pain - Visual Analog Scale (VAS)
Description
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.
Time Frame
At baseline
Title
nociceptive pain - Visual Analog Scale (VAS)
Description
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.
Time Frame
after 8 weeks of intervention
Title
nociceptive pain - Visual Analog Scale (VAS)
Description
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.
Time Frame
after 18 weeks
Title
neuropathic pain- DN4 scale
Description
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.
Time Frame
At baseline
Title
neuropathic pain- DN4 scale
Description
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.
Time Frame
after 8 weeks of intervention
Title
neuropathic pain- DN4 scale
Description
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.
Time Frame
after 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mouffias' Medical Center in Guadeloupe.
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Yoga for Chronic Chikungunya
We'll reach out to this number within 24 hrs