Chikungunya Virus InfectionYOCHIKNCT04455919
Yoga for Chronic Chikungunya
A study testing Wait-list group and Yoga group in people with Chikungunya Virus Infection, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- Wait-list group and Yoga group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 3 Oct 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Mouffias' Medical Center in Guadeloupe.
Pointe-à-Pitre, 97159
About this study
Official title: Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Chikungunya Virus Infection
- Being tested
- Wait-list group, Yoga group
- Keywords
- chikungunya virus, yoga, chronic chikungunya
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wait-list groupOther
The wait-list group benefit from a 8-week yoga program after the interventional group
Yoga groupOther
During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Yoga classes once a week for eight weeks Receives: Other: Yoga group |
| Wait-list control | Other | The delayed intervention group was to benefit from the intervention after week 8. Receives: Other: Wait-list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
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.
Measured: after 8 weeks of intervention
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.
Measured: after 18 weeks
Secondary outcomes (6)
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.
Measured: At baseline
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.
Measured: after 8 weeks of intervention
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.
Measured: after 18 weeks
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.
Measured: At baseline
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.
Measured: after 8 weeks of intervention
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.
Measured: after 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start3 Oct 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: covid health crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized wait-list controlled design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455919
- Sponsor's protocol ID
- PAP/RI2/2019_05
- Other IDs
- 2019-A01632-55
- Acronym
- YOCHIK
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Yoga on Quality of Life in Patients With Chronic Chikungunya: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04455919
- Acronym / sponsor ID
- YOCHIK / PAP/RI2/2019_05
- Conditions
- Chikungunya Virus Infection
- Keywords
- chikungunya virus, yoga, chronic chikungunya
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: covid health crisis
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized wait-list controlled design
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: Yoga groupYoga classes once a week for eight weeks |
| Wait-list control | Other | Other: Wait-list groupThe delayed intervention group was to benefit from the intervention after week 8. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wait-list groupThe wait-list group benefit from a 8-week yoga program after the interventional group | Other | Wait-list control |
| Yoga groupDuring 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home | Other | Yoga |
Primary outcome
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.
6 secondary outcomes
nociceptive pain - Visual Analog Scale (VAS)
Time frame: At baseline
nociceptive pain - Visual Analog Scale (VAS)
Time frame: after 8 weeks of intervention
nociceptive pain - Visual Analog Scale (VAS)
Time frame: after 18 weeks
neuropathic pain- DN4 scale
Time frame: At baseline
neuropathic pain- DN4 scale
Time frame: after 8 weeks of intervention
neuropathic pain- DN4 scale
Time frame: after 18 weeks
Results and safety
The study was stopped early (reason given: covid health crisis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wait-list group and Yoga group in people with Chikungunya Virus Infection, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: covid health crisis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life - Short Form-36 (SF-36) (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.