Yoga for Chronic Chikungunya

NCT04455919 | Terminated

• 2 other identifiers: PAP/RI2/2019_052019-A01632-55
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chikungunya Virus Infection

Keywords

chikungunya virus; yoga; chronic chikungunya

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  after 18 weeks

Secondary Outcomes (6)

• nociceptive pain - Visual Analog Scale (VAS)

  At baseline

• nociceptive pain - Visual Analog Scale (VAS)

  after 8 weeks of intervention

• nociceptive pain - Visual Analog Scale (VAS)

  after 18 weeks

• neuropathic pain- DN4 scale

  At baseline

• neuropathic pain- DN4 scale

  after 8 weeks of intervention

Study Arms (2)

Yoga

EXPERIMENTAL

Yoga classes once a week for eight weeks

Other: Yoga group

Wait-list control

OTHER

The delayed intervention group was to benefit from the intervention after week 8.

Other: Wait-list group

Interventions

Wait-list group OTHER

The wait-list group benefit from a 8-week yoga program after the interventional group

Wait-list control

Yoga group OTHER

During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home

Yoga

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Mouffias' Medical Center in Guadeloupe.

Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized wait-list controlled design

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: October 3, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)