Protocol for a Pilot Randomized Controlled Trial of the Evaluation of Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Dropout rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Dropout rates
时间窗: This will be measured on a continued basis up to 12 weeks.
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.
Percentage of missing data in the questionnaires
时间窗: This will be measured on a continued basis up to 12 weeks.
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.
Self-reported adherence to the interventions using a modified Physical activity report calendar
时间窗: This will be measured each week up to 12 weeks.
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).
Recruitment rate
时间窗: This will be measured on a continued basis up to 12 weeks.
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.
Randomization process
时间窗: This will be measured on a continued basis up to 12 weeks.
The ease at which the randomization process is conducted will be described by researchers in a feasibility form.
Number of protocol deviations
时间窗: This will be measured on a continued basis up to 12 weeks.
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.
Acceptability of the interventions: questionnaire
时间窗: This will be assessed at 6 and 12 weeks.
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.
Usability of Facebook: System Usability Scale
时间窗: This will be measured at 6 and 12 weeks.
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).
Usability of GoToMeeting: System Usability Scale
时间窗: This will be measured at 6 and 12 weeks.
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).
Use of Facebook
时间窗: This will be measured at 6 and 12 weeks.
The use of Facebook will be assessed by the number of posts, live online discussions and views of the videos.
次要结局
- Change in level of physical activity using the Physical Activity Questionnaire for adolescents(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 measured at baseline, 6 weeks and 12 weeks.)
- Change in morning stiffness using self-reported questions(This will be measured at baseline, 6 weeks and 12 weeks.)
- Change in self-Efficacy using the Children's Arthritis Self-Efficacy Scale(This will be measured at baseline, 6 weeks and 12 weeks.)
- Change in fatigue using the PROMIS Pediatric Short Form v1.0 - Fatigue 10a(This will be measured at baseline, 6 weeks and 12 weeks.)
- Change in functional status using the Childhood Health Assessment Questionnaire(This will be measured at baseline, 6 weeks and 12 weeks.)
- Change in pain intensity using the Childhood Health Assessment Questionnaire(This will be measured at baseline, 6 weeks and 12 weeks.)
- Patient Global Assessment using the Juvenile Arthritis Quality of Life Questionnaire(This will be measured at 6 weeks and 12 weeks.)
研究者
Karine Toupin-April
Associate Scientist
Children's Hospital of Eastern Ontario