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

31. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Migraine severity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
High Mobility Group Box 1 (HMGB1) Level
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hacettepe University

Ermittler

  • Hauptermittler: Ozlem Ulger, Hacettepe University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Februar 2028

Studienabschluss (Geschätzt)

1. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

31. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2026

Zuerst gepostet (Tatsächlich)

3. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CALM-Migraine-01

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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