Comprehensive Approach to Lifestyle Modification in Chronic Migraine (CALM-Migraine)
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
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Ozlem Ulger, PhD
- Numer telefonu: +903123051576
- E-mail: ozlemulger@yahoo.com
Kopia zapasowa kontaktu do badania
- Nazwa: Sinan Buran, MSc
- Numer telefonu: +903123052525
- E-mail: pt.sinanburan@gmail.com
Lokalizacje studiów
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Ankara, Turcja (Türkiye), 06100
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
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Kontakt:
- Ozlem Ulger, PhD
- Numer telefonu: +903123051576
- E-mail: ozlem.ulger@hacettepe.edu.tr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Migraine severity
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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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.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Average Attack Duration
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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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.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Total Number of Attacks
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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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.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Migraine Disability Assessment (MIDAS)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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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.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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High Mobility Group Box 1 (HMGB1) Level
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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NOD-Like Receptor Family Pyrin Domain Containing 3 (NLRP3) Level
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Objective Physical Activity Measurement (ActiGraph LEAP™ Activity Monitor)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Physical activity outcomes will include step count, sedentary time (ST), light physical activity (LPA), and moderate-to-vigorous physical activity (MVPA).
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Consumption of Migraine-Triggering Foods and Associated Headache Severity
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Healthy Eating Index-2020 (HEI-2020)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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10-item Perceived Stress Scale (PSS-10)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Objective Sleep Measurement (ActiGraph LEAP™ Activity Monitor)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Objective sleep outcomes will include total sleep time, sleep latency, and sleep efficiency.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Pittsburgh Sleep Quality Index (PSQI)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Epworth Sleepiness Scale (ESS)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Risky Substance Use
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Risky substance use will be assessed based on smoking exposure (pack-years) and alcohol consumption (drinks/week).
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Multidimensional Scale of Perceived Social Support (MSPSS)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Body Composition (Tanita MC-780-MA Body Composition Analyzer)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Body composition outcomes will include body weight, body fat percentage, fat mass, fat-free mass, and skeletal muscle mass.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Heart Rate Variability (HRV)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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HRV outcomes will include mean RR interval, SDNN, RMSSD, pNN50, low-frequency (LF) power, high-frequency (HF) power, and the LF/HF ratio.
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Montreal Cognitive Assessment (MoCA)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Task-Specific Cognitive Assessment
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Computerized Stroop and N-Back Tasks
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Chronic Headache Self-Efficacy Scale (CHASE)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Migraine Specific Quality of Life Questionaire version 2.1 (MSQ v2.1)
Ramy czasowe: Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Baseline (T0), post-intervention at 8 weeks (T1), 3 months after baseline (T2), and 6 months after baseline (T3)
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Ozlem Ulger, Hacettepe University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- CALM-Migraine-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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