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
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Ozlem Ulger, PhD
- Puhelinnumero: +903123051576
- Sähköposti: ozlemulger@yahoo.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Sinan Buran, MSc
- Puhelinnumero: +903123052525
- Sähköposti: pt.sinanburan@gmail.com
Opiskelupaikat
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Ankara, Turkki (Türkiye), 06100
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
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Ottaa yhteyttä:
- Ozlem Ulger, PhD
- Puhelinnumero: +903123051576
- Sähköposti: ozlem.ulger@hacettepe.edu.tr
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Kokeellinen: 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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Ei väliintuloa: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Migraine severity
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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High Mobility Group Box 1 (HMGB1) Level
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Ozlem Ulger, Hacettepe University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
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