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Comprehensive Approach to Lifestyle Modification in Chronic Migraine (CALM-Migraine)

2026. augusztus 31. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

30

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Viselkedési: Comprehensive Lifestyle Intervention
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.
Nincs beavatkozás: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Migraine severity
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
High Mobility Group Box 1 (HMGB1) Level
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Hacettepe University

Nyomozók

  • Kutatásvezető: Ozlem Ulger, Hacettepe University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 1.

Elsődleges befejezés (Becsült)

2028. február 1.

A tanulmány befejezése (Becsült)

2028. február 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 31.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 31.

Első közzététel (Tényleges)

2026. szeptember 3.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 3.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 31.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CALM-Migraine-01

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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