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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The yoga training program is a structured low-intensity Vishwas-Raj (18). This yoga program consists of stretching, strengthening, meditation and deep breathing, and has been shown to be effective among adults with RA. Participants will be asked to complete three individual 1-hour sessions per week for 12 consecutive weeks by watching a previously filmed session led by a qualified yoga instructor and posted on Facebook. They will also take part in a 1-hour virtual group session per week using a video-conferencing platform. Participants will also participate in weekly e-consultations with a research coordinator and discussions on Facebook with other participants.
The aerobic dance program is a low to moderate intensity level program and will also use a video. The video, adapted for youth with JIA, was developed with feedback from a JIA patient with experience in aerobic dance and a physiotherapist with experience in pediatric rheumatology. The aerobic dance program will have the same characteristics in terms of frequency, total number of sessions and total duration as the yoga program (i.e., three 1-hour individual sessions and one 1-hour virtual group session per week for 12 weeks). Participants will also participate in weekly e-consultations with a research coordinator and discussions on Facebook with other participants.
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, Canada
Recruitment rate
The number of participants recruited in the trial and the time used for recruitment will be documented in a feasibility form. The number of participants will be divided by the time used for recruitment.
Time frame: This will be measured on a continued basis up to 12 weeks.
Randomization process
The ease at which the randomization process is conducted will be described by researchers in a feasibility form.
Time frame: This will be measured on a continued basis up to 12 weeks.
Number of protocol deviations
The number of protocol deviations, the time at which they occur, the group in which they occur and the potential reasons for these will be documented in a feasibility form. Participants will be asked the reasons why they deviated from the protocol by researchers using a feasibility form.
Time frame: This will be measured on a continued basis up to 12 weeks.
Dropout rates
The number of participants who drop out of the trial, the time at which they drop out, the group in which they belong and the reasons for these will be documented in a feasibility form. Participants will be asked the reasons why they drop out by researchers. The number of dropouts in each group will be divided by the time of the trial.
Time frame: This will be measured on a continued basis up to 12 weeks.
Percentage of missing data in the questionnaires
The percentage of missing data in the questionnaires, the time at which they occur and potential reasons for these will be documented in a feasibility form.
Time frame: This will be measured on a continued basis up to 12 weeks.
Self-reported adherence to the interventions using a modified Physical activity report calendar
Self-reported adherence to the aerobic dance and yoga training programs will be assessed by monitoring the number and length of sessions, and dividing the time spent performing the program by the time of prescribed sessions of either yoga or aerobic dance. Self-reported adherence will be recorded weekly using an adapted online version of the validated 7-day Physical Activity Report (PAR) calendar (in minutes).
Time frame: This will be measured each week up to 12 weeks.
Acceptability of the interventions: questionnaire
Acceptability of the yoga or aerobic dance interventions will be assessed using a questionnaire administered post-intervention. Questions will explore the acceptability of the e-consultations, virtual group sessions, the PA videos (either yoga or aerobic dance programs), the e-pamphlet and the training programs (content and duration of the yoga and aerobic dance programs), as well as facilitators and barriers to participating.
Time frame: This will be assessed at 6 and 12 weeks.
Usability of Facebook: System Usability Scale
The usability of Facebook will be assessed by the System Usability Scale (SUS). The SUS is composed of 10 items using a 5-point scoring system ranging from Strongly disagree (score of 1 out of 5 for each question) to Strongly Agree (score of 5 out of 5 for each question). The total score ranges from 5 (low usability) to 50 (high usability).
Time frame: This will be measured at 6 and 12 weeks.
Usability of GoToMeeting: System Usability Scale
The usability of GoToMeeting will be assessed by the System Usability Scale (SUS). The SUS is composed of 10 items using a 5-point scoring system ranging from Strongly disagree (score of 1 out of 5 for each question) to Strongly Agree (score of 5 out of 5 for each question). The total score ranges from 5 (low usability) to 50 (high usability).
Time frame: This will be measured at 6 and 12 weeks.
Use of Facebook
The use of Facebook will be assessed by the number of posts, live online discussions and views of the videos.
Time frame: This will be measured at 6 and 12 weeks.
Change in pain intensity using the Childhood Health Assessment Questionnaire
Pain intensity will be assessed by the online Childhood Health Assessment Questionnaire (CHAQ) 100-mm pain VAS sub-scale. It uses a scoring system where 0 mm represents "no pain" and 100 mm "very severe pain" in the past week. This measure has already been validated in the JIA population. A repeated measures analysis of variance (ANOVA) with the fixed factor study group and the within factor assessment time (0, 6, 12 weeks) will be conducted to compare groups at 0, 6 and 12 weeks.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Change in level of physical activity using the Physical Activity Questionnaire for adolescents
Participation in physical activity will be assessed by the online Physical Activity Questionnaire for adolescents (PAQ-A) ages ranging from 14-18 years, a seven-day recall instrument measuring the level of physical activity within the last 7 days. The PAQ-A is composed of eight items using a 5-point scoring system. The total score is calculated by taking the mean score out of 5, with 1 indicating low physical activity and 5 indicating high physical activity. The PAQ-A has been reported to be a valid and reliable measure of general physical activity levels in youth and adolescents. A repeated measures analysis of variance (ANOVA) with the fixed factor study group and the within factor assessment time (0, 6, 12 weeks) will be conducted to compare groups at 0, 6 and 12 weeks.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Change in duration and intensity of physical activity using the Physical Activity Report Calendar
This will be assessed by an exercise log, based on the 7-day PAR calendar. Physical activity level will be reported in terms of minutes and intensity levels (three subscales: moderate, hard and very hard intensity: subscale total scores in minutes) and will be transformed into metabolic equivalent of tasks (METS), which are units of the basal metabolic rate and are expressing the energy cost of physical activity. A repeated measures analysis of variance (ANOVA) with the fixed factor study group and the within factor assessment time (0, 6, 12 weeks) will be conducted to compare groups at 0, 6 and 12 weeks.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Change in morning stiffness using self-reported questions
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Morning stiffness will be assessed by online self-reported questions asking about the presence (Yes/No) and duration of morning stiffness in minutes. A repeated measures analysis of variance (ANOVA) with the fixed factor study group and the within factor assessment time (0, 6, 12 weeks) will be conducted to compare groups at 0, 6 and 12 weeks.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Change in functional status using the Childhood Health Assessment Questionnaire
Functional status will be assessed by the online Childhood Health Assessment Questionnaire (CHAQ). CHAQ contains 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) and items are scored using a 4-point Likert scale of 0-3 where 0 represents the ability to perform the activity with no difficulty; 1, the ability to perform with some difficulty; 2, the ability to perform with much difficulty; and 3, the inability to perform over the past week. The mean of the 8 scores will determine the total CHAQ score ranging from 0 to 3, with a lower score indicating higher functional status and a higher score indicating lower functional status. It is the most widely used functional health status measure in JIA, which is a reliable and valid tool for the functional, physical and psychosocial assessment of children with JIA.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Change in fatigue using the PROMIS Pediatric Short Form v1.0 - Fatigue 10a
Fatigue will be assessed by an online version of a subset of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form v1.0 - Fatigue 10a which measures fatigue experiences and its impact, scored from 1 to 5, where 1 represents "never tired" and 5 "almost always tired" in the past week. A repeated measures analysis of variance (ANOVA) with the fixed factor study group and the within factor assessment time (0, 6, 12 weeks) will be conducted to compare groups at 0, 6 and 12 weeks.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Change in self-Efficacy using the Children's Arthritis Self-Efficacy Scale
Self-Efficacy will be assessed by the Children's Arthritis Self-Efficacy Scale (CASE), a specific valid and reliable tool for JIA. The CASE is an 11-item self-report scale that is divided into three concepts: activity, symptom and emotion. A 5-point Likert scale is used to rate responses for each item where 1 = "not at all sure" to 5 = "very sure" based on how confident the child is that they can manage disease effects. A repeated measures analysis of variance (ANOVA) with the fixed factor study group and the within factor assessment time (0, 6, 12 weeks) will be conducted to compare groups at 0, 6 and 12 weeks.
Time frame: This will be measured at baseline, 6 weeks and 12 weeks.
Patient Global Assessment using the Juvenile Arthritis Quality of Life Questionnaire
Patient Global Assessment will be assessed by an item used in the Juvenile Arthritis Quality of Life Questionnaire (JAQQ). The JAQQ was designed to assess the health-related quality of life in children aged 2-18 years with juvenile rheumatoid arthritis or juvenile spondylarthritides. The JAQQ includes four subscales (gross motor function, fine motor function, psychosocial function and systemic symptoms), as well as a pain and patient global assessment. The patient global assessment asks how youth have been since the last assessment (prior week) on a 5-point likert scale from much better (1) to much worse (5).
Time frame: This will be measured at 6 weeks and 12 weeks.