An Exercise Training Intervention for Depressive Symptoms in Youth With MS: A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Participant accrual rate
研究概览
简要总结
This multi-center, randomized controlled feasibility trial will assess a 20-week home-based exercise intervention in youth with Multiple Sclerosis (MS). The goal is to determine the feasibility of conducting a larger, definitive trial on exercise training as a non-pharmacological approach to improve disease outcomes in this population.
Participants will be randomized to either an Exercise Training group or a Mobility and Flexibility Training group. The investigators will evaluate differences between the two groups in physical activity levels, mediators of physical activity, and psychosocial outcomes. Assessments, including clinical exams, brain MRI, eye tracking, cognitive testing, blood draws, and questionnaires, will occur at baseline and after 20 weeks. Accelerometry will be done at baseline, 10 weeks, and 20 weeks to track physical activity.
The primary objectives are to assess the feasibility of recruiting, retaining, and randomizing youth with MS and to evaluate adherence to the exercise intervention and coaching sessions. Exploratory objectives include examining changes in depressive symptoms, cognitive function, blood biomarkers (BDNF and irisin), brain volume, and fitness levels in response to the intervention.
Approximately 40 participants will be enrolled from four sites in Canada and the United States.
Primary outcomes include feasibility, acceptability, and fidelity measures. Exploratory outcomes include blood biomarkers, brain MRI, cognitive testing, and other neuropsychological measures.
详细描述
Overview: This research study explores the potential of exercise as a non-pharmacological treatment for youth with Multiple Sclerosis (MS). The investigators are conducting a 20-week home-based exercise program to determine if it is feasible to implement this type of intervention in a larger trial in the future. Our ultimate goal is to understand how exercise might help improve both physical and mental health outcomes for youth with MS.
Why This Study is Important: Multiple Sclerosis is a chronic disease that affects the brain and spinal cord, often leading to issues with movement, balance, vision, and other body functions. In young people, MS can have a significant impact on daily life, including mental health and cognitive abilities (such as memory and problem-solving). Medications can help manage symptoms, but there is growing interest in non-medication approaches, like exercise, to enhance the overall well-being of youth with MS. This study aims to investigate whether a structured exercise program can benefit physical fitness, mental health, and brain function in young people living with MS.
Study Design: This feasibility trial will enroll approximately 40 participants from four different locations in Canada and the United States. These participants will be youth diagnosed with MS.
Participants will be randomly assigned to one of two groups:
- Exercise Training Group: Participants will follow a 20-week home-based exercise program, which includes structured exercises designed to improve physical fitness.
- Mobility and Flexibility Training: Participants in this group will follow a 20-week program focused on mobility and flexibility exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
To avoid bias or influence in outcomes, participants will not be informed which training group is the intervention group and which is the sham/control group.
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth and young adults 11-25 years of age
- •MS diagnosis or clinically isolated syndrome per revised McDonald diagnostic criteria and International Pediatric MS Study Group Criteria
- •A score of 10 or above on the CES-DC scale.
排除标准
- •Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities
- •Do not speak and read English at a level needed to complete the questionnaires (4th grade level)
- •Have significant motor disability (EDSS ≥4)
- •Are at increased risk of cardiac or other complications of exercise testing, as determined by the pediatric neurologist or physician
结局指标
主要结局
Participant accrual rate
时间窗: From enrollment to the end of study
Number of participants enrolled per year
Fidelity of delivering the intervention
时间窗: From enrollment to the end of intervention at 20 weeks
ASPIRE fidelity coaching checklist. This measure assesses the fidelity with which study coaches deliver the intervention during calls with participants. Participants are scored on a scale from 0 to 2, based on the extent to which the intervention components are covered: 0: Did not cover - The intervention component was not addressed during the call. 1. Partially covered - The intervention component was addressed to some extent, but not fully. 2. Fully covered - The intervention component was fully addressed, meeting the intended criteria for delivery. A higher score reflects a more complete and accurate delivery of the intervention as planned.
Participant drop-out rate
时间窗: From enrollment to the end of study
Percentage of total patients that dropped out of study.
Adverse event rate
时间窗: From enrollment to the end of study
Number of adverse events per total participants
Completion rate of study measures
时间窗: From enrollment to the end of study
Percentage of total patients that completed the study measures.
次要结局
未报告次要终点
研究者
E. Ann Yeh
Staff Neurologist
The Hospital for Sick Children