Comprehensive Approach to Lifestyle Modification in Chronic Migraine (CALM-Migraine)
2026年8月31日 更新者：Ozlem Ulger、Hacettepe University
Investigation of the Effectiveness of a Lifestyle-Based Intervention on Migraine-Related Clinical Outcomes, Neuroinflammatory Biomarkers, Health-Related Lifestyle Behaviors, Body Composition, Autonomic Nervous System Function, Cognitive Function, Self-Efficacy, and Quality of Life in Patients With Chronic Migraine
Migraine is a highly prevalent neurological disorder and one of the leading causes of disability worldwide, substantially affecting quality of life and individuals during their most productive years.
Chronic migraine, defined as headache occurring on ≥15 days per month for more than three months, is a particularly disabling form of the disease.
Physical inactivity, unhealthy dietary behaviors, stress, sleep disturbances, risky substance use, and inadequate social support may contribute to the burden and chronification of migraine.
The CALM-Migraine trial aims to investigate the effects of a comprehensive lifestyle-based intervention in individuals with chronic migraine.
Participants will be randomly assigned to either a lifestyle intervention group or a wait-list control group.
Participants allocated to the lifestyle intervention group will receive an 8-week comprehensive lifestyle intervention alongside their usual pharmacological treatment.
The intervention will consist of supervised exercise training, structured patient education, and peer support sessions delivered under the supervision of a physiotherapist.
It will address the six pillars of lifestyle medicine: physical activity, diet, mental health and stress management, sleep, risky substance use, and social connections.
The study will evaluate the intervention's effects on migraine-related clinical outcomes, neuroinflammatory biomarkers, health-related lifestyle behaviors, body composition, autonomic nervous system function, cognitive function, self-efficacy, and quality of life.
Participants will be followed after the intervention to assess whether the effects are maintained over time.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ozlem Ulger, PhD
- 电话号码：+903123051576
- 邮箱：ozlemulger@yahoo.com
研究联系人备份
- 姓名：Sinan Buran, MSc
- 电话号码：+903123052525
- 邮箱：pt.sinanburan@gmail.com
学习地点
-
-
-
Ankara、土耳其（türkiye）、06100
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
-
接触：
- Ozlem Ulger, PhD
- 电话号码：+903123051576
- 邮箱：ozlem.ulger@hacettepe.edu.tr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Having been diagnosed with chronic migraine according to the ICHD-3 diagnostic criteria after a neurological examination by a Neurology Specialist
- Not having a regular medication habit other than for migraine pain
- No changes in current medication management during the study period
- Being between 18-55 years of age
Exclusion Criteria:
- Having headache types other than chronic migraine
- Having rheumatological diseases characterized by chronic widespread pain, such as fibromyalgia
- Having neurological, orthopedic, or cardiovascular conditions that may prevent the individual from participating in exercise
- Comorbid conditions other than migraine that are known to adversely affect cognitive functioning (e.g., traumatic brain injury, personality disorders, post-traumatic stress disorder, bipolar affective disorder, etc.)
- Use of medications that may affect autonomic function
- Receiving hormone replacement therapy
- Receiving antihypertensive treatment
- Having undergone botulinum toxin application within the last six months
- Having undergone invasive procedures such as dry needling/injection within the last six months
- Pregnancy
- For female patients, being postmenopausal
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lifestyle Intervention Group
Participants in this arm will receive an 8-week comprehensive lifestyle intervention in addition to their usual pharmacological treatment.
The intervention will include supervised exercise training, structured patient education, and peer support sessions and will address the six pillars of lifestyle medicine: physical activity, diet, mental health and stress management, sleep, risky substance use, and social connections.
|
Participants allocated to the lifestyle intervention group will receive an 8-week comprehensive lifestyle intervention alongside their usual pharmacological treatment.
The intervention will consist of 24 individual, face-to-face sessions delivered three times per week under a physiotherapist's supervision.
The intervention will address the six pillars of lifestyle medicine: physical activity, diet, mental health and stress management, sleep, risky substance use, and social connections.
It will include three main components: supervised exercise training, structured patient education, and peer support sessions.
|
|
无干预：Wait-list control group
Participants in this arm will continue their usual pharmacological treatment and will not receive the lifestyle intervention during the study period.
They will be asked to maintain a migraine diary throughout the study.
After the study, wait-list control group participants will be offered the same intervention protocol as the lifestyle intervention group, in compliance with ethical standards.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Migraine severity
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Migraine severity will be assessed using the Visual Analog Scale (VAS).
For each migraine attack, participants will indicate pain intensity on a 10-cm horizontal line anchored from "no pain" to "worst imaginable pain."
The distance from the left endpoint to the participant's mark will be measured in centimeters, with higher values indicating greater migraine severity.
Participants will prospectively record migraine severity for each attack in a migraine diary throughout the study.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Average Attack Duration
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Average migraine attack duration will be determined using prospectively recorded migraine diary data.
Participants will record each migraine attack duration in hours, and the average attack duration will be calculated for the relevant assessment period.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Total Number of Attacks
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Participants will prospectively record each migraine attack using a migraine diary throughout the study.
The diary records will determine the total number of migraine attacks for each relevant assessment period.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Migraine Disability Assessment (MIDAS)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Migraine-related disability will be assessed using the Migraine Disability Assessment (MIDAS) questionnaire.
The MIDAS total score is calculated by summing the first five items, which assess the number of days with missed or reduced productivity at work or school, in household activities, and in social or leisure activities during the previous 3 months.
Higher total scores indicate greater migraine-related disability.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
High Mobility Group Box 1 (HMGB1) Level
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
NOD-Like Receptor Family Pyrin Domain Containing 3 (NLRP3) Level
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Objective Physical Activity Measurement (ActiGraph LEAP™ Activity Monitor)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Physical activity outcomes will include step count, sedentary time (ST), light physical activity (LPA), and moderate-to-vigorous physical activity (MVPA).
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Consumption of Migraine-Triggering Foods and Associated Headache Severity
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Healthy Eating Index-2020 (HEI-2020)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
10-item Perceived Stress Scale (PSS-10)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Hospital Anxiety and Depression Scale (HADS)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Objective Sleep Measurement (ActiGraph LEAP™ Activity Monitor)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Objective sleep outcomes will include total sleep time, sleep latency, and sleep efficiency.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Pittsburgh Sleep Quality Index (PSQI)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Epworth Sleepiness Scale (ESS)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Risky Substance Use
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Risky substance use will be assessed based on smoking exposure (pack-years) and alcohol consumption (drinks/week).
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Multidimensional Scale of Perceived Social Support (MSPSS)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Body Composition (Tanita MC-780-MA Body Composition Analyzer)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Body composition outcomes will include body weight, body fat percentage, fat mass, fat-free mass, and skeletal muscle mass.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Heart Rate Variability (HRV)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
HRV outcomes will include mean RR interval, SDNN, RMSSD, pNN50, low-frequency (LF) power, high-frequency (HF) power, and the LF/HF ratio.
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Montreal Cognitive Assessment (MoCA)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Task-Specific Cognitive Assessment
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Computerized Stroop and N-Back Tasks
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
Chronic Headache Self-Efficacy Scale (CHASE)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
|
|
Migraine Specific Quality of Life Questionaire version 2.1 (MSQ v2.1)
大体时间：Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ozlem Ulger、Hacettepe University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年2月1日
研究完成 (估计的)
2028年2月1日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月3日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.