Comprehensive Approach to Lifestyle Modification in Chronic Migraine

NCT07802860 | Not Yet Recruiting

• 1 other identifier: CALM-Migraine-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine, Headache

Keywords

Lifestyle; Physical Activity; Exercise; Nutrition; Stress Management; Sleep; Social Support; Cognitive Function; Heart Rate Variability; Neuroinflammation; Quality of Life; Patient Education; Peer Support; Relaxation Training

Outcome Measures

Primary Outcomes (4)

• Migraine severity

  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

  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

  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)

  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)

Secondary Outcomes (18)

• High Mobility Group Box 1 (HMGB1) Level

  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

  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)

  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

  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)

  Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)

Study Arms (2)

Lifestyle Intervention Group

EXPERIMENTAL

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.

Behavioral: Comprehensive Lifestyle Intervention

Wait-list control group

NO INTERVENTION

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.

Interventions

Comprehensive Lifestyle Intervention BEHAVIORAL

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.

Lifestyle Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache; Motor Activity; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Nervous System Diseases; Inflammation; Pathologic Processes

Study Officials

• Ozlem Ulger

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozlem Ulger, PhD

CONTACT

+903123051576; ozlemulger@yahoo.com

Sinan Buran, MSc

CONTACT

+903123052525; pt.sinanburan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A physiotherapist will perform outcome assessments and be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)