Clinical trial NCT03833609: Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis
Official title: Protocol for a Pilot Randomized Controlled Trial of the Evaluation of Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Pain
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Université de Montréal
name: University of Ottawa
First posted: 2019-02-07
Enrollment: 25
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will use a three-arm prospective randomized open-label study. Participants will be randomized to one of the three following groups in a ratio of 2:2:1: A) an online yoga training program (+ physical activity (PA) electronic educational pamphlet) (n=10), B) an online aerobic dance training program (+ PA electronic educational pamphlet) (n=10) and C) a wait list control group (+ PA electronic educational pamphlet) (n=5). The total intervention period is 12 consecutive weeks. The frequency and duration of the intervention is based on other trials of yoga and physical activity interventions in pediatric and adult rheumatology.
Primary purpose: TREATMENT

Brief summary: The primary objectives of the proposed pilot randomized controlled trial (RCT) will be to examine: (1) the feasibility of a full RCT to evaluate the effectiveness of two popular types of physical activity (PA), a yoga training program and an aerobic dance training program, in female adolescents (13 to 18 years old) with juvenile idiopathic arthritis (JIA) compared to a wait list control group; and (2) the acceptability of these interventions. A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 in a ratio of 2:2:1 female adolescents with JIA who have pain will be randomized to one of the three groups: 1) online yoga training program (Group A) (n=10), 2) online aerobic dance training program (Group B) (n=10) and 3) waiting list control group (Group C) (n=5). Participants in groups A and B will complete three individual 1-hour sessions per week using online exercise videos, as well as one 1-hour virtual group session per week using a video-conferencing platform (GoToMeeting) for 12 weeks. These participants will also take part in weekly e-consultations with a research coordinator and discussions on Facebook with other participants. Participants from all groups will be given access to an electronic educational pamphlet on PA for arthritis developed by The Arthritis Society to review via an online platform. Feasibility, acceptability and usability of Facebook and GoToMeeting will be assessed at the end of the program. Pain intensity (Primary outcome), participation in general physical activity, morning stiffness, functional status, fatigue, self-efficacy and patient global assessment will be assessed using self-administered electronic surveys at baseline, weekly until the end of the 12 weeks program.

Detailed description: Objectives: The primary objectives of the proposed pilot randomized controlled trial (RCT) will be to examine: (1) the feasibility of a full RCT to evaluate the effectiveness of two popular types of physical activity (PA), a yoga training program and an aerobic dance training program, in female adolescents (13 to 18 years old) with juvenile idiopathic arthritis (JIA) compared to a wait list control group; and (2) the acceptability of these interventions.

Methods: A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the three groups: 1) online yoga training program (Group A) (n=10), 2) online aerobic dance training program (Group B) (n=10) and 3) wait list control group (Group C) (n=5). Participants in groups A and B will complete three individual 1-hour sessions per week using online exercise videos, as well as one 1-hour virtual group session per week using a video-conferencing platform (GoToMeeting) for 12 weeks. These participants will also take part in weekly e-consultations with a research coordinator and discussions on Facebook with other participants. Participants from all groups will be given access to an electronic educational pamphlet on PA for arthritis developed by The Arthritis Society to review via an online platform. Feasibility (recruitment rates, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability and usability of Facebook and GoToMeeting will be assessed at the end of the program. Pain intensity (Primary outcome), participation in general physical activity, morning stiffness, functional status, fatigue, self-efficacy and patient global assessment will be assessed using self-administered electronic surveys at baseline, weekly until the end of the 12 weeks program.

Conclusion: To our knowledge this is the first study in paediatric patients to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online tools such as Facebook and GoToMeeting to disseminate these two PA interventions may facilitate access to alternative methods of pain management in this population. The study design incorporates randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to "closed", thus only allowing invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this physical intervention pilot randomized controlled trial and a potential bias of recruiting more severe hospital-based participants. Reporting of the study follows the Standard Protocol Items: Recommendations for interventional trials (SPIRIT) statement. This study can lead to a full-scale RCT.

Eligibility criteria: Inclusion Criteria:

* Female adolescents aged between 13 -18 years old
* Diagnosis of JIA by a rheumatologist according to ILAR criteria
* Absence of serious co-morbidities, chronic diseases or of chronic pain that is unrelated to JIA (e.g., cancer, fibromyalgia), which may impact ability to understand and use the exercise program or complete outcome assessments (as determined by the treating rheumatologist)
* Presence of arthritis-related pain during regular activities of at least 30 on a 100-millimeter (mm) visual analogue scale (VAS) in the past month
* JIA specific medication regimen not expected to change during the study period
* Self-reported as not meeting Health Canada's and American College of Sports Medicine's guidelines for PA (\<60 minutes of moderate to vigorous PA per day) and not using physical interventions/treatments other than medication prescribed for JIA pain relief or over the counter medication
* Capable of using and accessing the Internet weekly for the study duration
* No contraindications to exercise (according to the treating rheumatologist)
* Understand English

Exclusion Criteria:

* Moderate to severe cognitive impairments (as determined by the treating rheumatologist)
* Presence of serious co-morbidities, chronic illnesses or of chronic pain that is unrelated to JIA (e.g., cancer, fibromyalgia), which may impact ability to understand and use the exercise program or complete outcome assessments (as determined by the treating rheumatologist)
* Presence of pain during regular activities lower than 30mm on a 100 mm VAS in the past month
* Self-reported as physically active according to Health Canada's and American College of Sports Medicine's PA guidelines (≥60 minutes of moderate to vigorous PA per day) or using physical interventions/agents other than medication prescribed for JIA pain relief or over the counter medication
* JIA specific medication regimen expected to change during the study period
* Incapable of using and accessing the Internet weekly during the study duration
* Presence of contraindications to exercise
* Do not understand English

Primary outcomes:
measure: Recruitment rate
timeFrame: This will be measured on a continued basis up to 12 weeks.
measure: Randomization process
timeFrame: This will be measured on a continued basis up to 12 weeks.
measure: Number of protocol deviations
timeFrame: This will be measured on a continued basis up to 12 weeks.
measure: Dropout rates
timeFrame: This will be measured on a continued basis up to 12 weeks.
measure: Percentage of missing data in the questionnaires
timeFrame: This will be measured on a continued basis up to 12 weeks.
measure: Self-reported adherence to the interventions using a modified Physical activity report calendar
timeFrame: This will be measured each week up to 12 weeks.
measure: Acceptability of the interventions: questionnaire
timeFrame: This will be assessed at 6 and 12 weeks.
measure: Usability of Facebook: System Usability Scale
timeFrame: This will be measured at 6 and 12 weeks.
measure: Usability of GoToMeeting: System Usability Scale
timeFrame: This will be measured at 6 and 12 weeks.
measure: Use of Facebook
timeFrame: This will be measured at 6 and 12 weeks.
Secondary outcomes:
measure: Change in pain intensity using the Childhood Health Assessment Questionnaire
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Change in level of physical activity using the Physical Activity Questionnaire for adolescents
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Change in duration and intensity of physical activity using the Physical Activity Report Calendar
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Change in morning stiffness using self-reported questions
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Change in functional status using the Childhood Health Assessment Questionnaire
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Change in fatigue using the PROMIS Pediatric Short Form v1.0 - Fatigue 10a
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Change in self-Efficacy using the Children's Arthritis Self-Efficacy Scale
timeFrame: This will be measured at baseline, 6 weeks and 12 weeks.
measure: Patient Global Assessment using the Juvenile Arthritis Quality of Life Questionnaire
timeFrame: This will be measured at 6 weeks and 12 weeks.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario Research Institute
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Karine Toupin April
role: PRINCIPAL_INVESTIGATOR
References: