MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducation for Adolescents With Migraine - Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change from baseline in migraine headache frequency
研究概览
简要总结
Background: Migraine is a headache disorder highly prevalent in children and adolescents. It significantly affects academic performance and quality of life. A conservative approach to pharmacological prophylaxis for pediatric patients persists in clinical practice, as potential risks must be carefully weighed against the benefits for each individual patient. Non-pharmacological interventions, including physical activity, progressive muscle relaxation (PMR) and psychoeducation have shown promising effects individually but demand a high level of patient motivation. This study protocol creates the foundation to evaluate a novel group therapy program combining high-intensity interval training (HIIT), PMR, and psychoeducation tailored for children and adolescents with migraine.
Methods: This single-centre, open-label, randomized controlled trial will enrol 80 participants aged 13 to 17 years and diagnosed with migraine according to ICHD-3 criteria. Participants are randomized 1:1 into an intervention and control group. The intervention group will receive a 18-week, once-weekly 65-minute group therapy (comprising HIIT and PMR) plus two sessions of psychoeducation. The control group receives no intervention. Primary outcomes are changes in migraine frequency, duration, intensity and acute medication use, assessed through standardized headache diaries before and after the intervention. Secondary outcomes include changes in migraine-related disability (PedMIDAS questionnaire), exploratory analysis of physical activity patterns in a subgroup and a patient-centered evaluation of the intervention's feasibility and perceived effectiveness.
Discussion: This trial will provide evidence on the effectiveness and feasibility of a structured, time-efficient, multimodal group therapy intervention for pediatric migraine. By combining physical and psychological strategies within a supportive group setting, the program aims to overcome key limitations of adherence and offer a non-pharmacological treatment alternative. If successful, the intervention is intended to be incorporated into routine outpatient care for pediatric migraine at the Medical University of Innsbruck.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed migraine as defined by ICHD-3 (International Classification of Headache Disorders, 3rd edition)
- •Age: 13-17 years
- •Place of residence within a 35-kilometer radius of the study site, except for children who live outside of this radius but commute close to the study site daily due to school or work attendance
排除标准
- •Intake of continuous prophylactic medication for migraine
- •Any change in migraine medication within the past 4 weeks
- •Psychiatric or somatic comorbidities which could interfere with participation in a weekly group therapy that includes physical activity
研究组 & 干预措施
Participant
干预措施: Weekly group training (Behavioral)
Controls
结局指标
主要结局
Mean change from baseline in migraine headache frequency
时间窗: From enrollment to the end of treatment at 4 weeks
Mean change from baseline in the number of monthly headache days, defined as any calendar day with headache.
Mean change from baseline in migraine intensity
时间窗: From enrollment to the end of treatment at 4 weeks
Mean change from baseline in migraine intensity measured using a 0-10 visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Mean change from baseline in migraine duration
时间窗: From enrollment to the end of treatment at 4 weeks
Mean change from baseline in the duration of migraine, expressed as the number of hours of pain per migraine day.
次要结局
- Degree of migraine-related impairment using the mean change in the PedMIDAS questionnaire´s total score(From enrollment to the end of treatment at 4 weeks)