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| Name | Class |
|---|---|
| University Of Perugia | OTHER |
| University Hospital Perugia | UNKNOWN |
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The study project aims to implement therapeutic patient education for migraine, promoting improvement in outpatient clinical practice by providing counseling moments specifically dedicated to known health risk factors (sedentary lifestyle, physical inactivity, unhealthy eating habits), thanks to the integration of the skills of Neurology Specialists and those of CURIAMo.
140 people with high-frequency, episodic or chronic migraine, referred to the Headache Center at Santa Maria della Misericordia Hospital in Perugia for neurological examination, will be able to join this project on a voluntary and free basis.
All study participants will be invited to participate a:
2b - self-administered (via a digital, online, form divided into four parts) and researcher-administered questionnaires; 2c - kinesiological assessment of functional capacities (aerobic capacity, muscle strength and flexibility); 2d - complete postural evaluation (divided into objective, instrumental, functional and neuromotor examination); 2e - traditional/complete gnathological evaluation, according to international diagnostic criteria.
According to a randomized allocation, participants will be assigned to two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1, 70 people with migraine in standard treatment (control arm). | Active Comparator | Standard care |
|
| Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised | Experimental | Standard care plus supervised exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise program supervised by specialized kinesiologists | Behavioral | The duration of the program is 12 weeks, with 2 sessions per week of mixed activities (aerobic exercises + muscle strengthening exercises). Each session lasts about 60 minutes, including a warm-up phase, a central phase and a cool-down phase. In particular, for aerobic exercises, the central phase involves the use of various ergometers (e.g. treadmill and cycle ergometer) and a moderate intensity of training (55-69% of Heart Rate Reserve), while for muscle strengthening exercises will be administered bodyweight exercises, with small tools (e.g. elastic bands, medicine ball, etc.) or with isotonic machines (e.g. lat machines and leg presses), with an initial work intensity of 45-50% of One Repetition Maximum. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of migraine attacks/month and Physical Activity levels | Relationships between lifestyle (in particular Physical Activity levels, and the number of migraine attacks/month | From the time of enrollment and at 6/12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Number of years of patients | At the time of enrollment |
| Blood glucose value | Blood glucose (mg/dL) of the patients. | at the time of enrollment and at 6/12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paola Sarchielli | Centro Cefalee dell'Azienda Ospedaliera di Perugia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CURIAMo | Perugia | PG | 06126 | Italy | ||
| Centro Cefalee c/o Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Two arms, randomized, controlled study
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|
| Standard neurological visit at the Headache Centre | Other | Participants will be invited to participate a:
2b - self-administered (via a digital, online, form divided into four parts) and researcher-administered questionnaires; 2c - kinesiological assessment of functional capacities (aerobic capacity, muscle strength and flexibility); 2d - complete postural evaluation (divided into objective, instrumental, functional and neuromotor examination); 2e - traditional/complete gnathological evaluation, according to international diagnostic criteria. |
|
| Weight | Weight (kg) assessed using a calibrate medical scale; | at the time of enrollement and after 6 and 12 months |
| Days lost or limited in activities over 3 months for migraine | Headache-related disability will be assessed by the Migraine Disability Assessment Score (MIDAS) Questionnaire. MIDAS is a migraine-specific questionnaire of 5 item aimed at assessing disability caused by headache, by measuring days lost (over 3 months) or limited in work, school, household work, and social activities. The score was obtain summing a total number of days from questions 1-5. Little or no disability=0-5. Mild disability=6-10. Moderate disability=11-20. Severe disability=21+ | at the time of enrollment and at 6/12 months |
| Impact of migraine on daily life | Quality of life will be assessed using the Migraine-Specific Quality of Life Questionnaire (MSQ). We will be used the Italian version 2.1, a 14-item questionnaire designed to measure how migraine affects and/or limits daily functioning. In a 0-100 scale, higher scores indicate a better quality of life (less impact of migraine) and lower scores indicate a worse quality of life (more disability). | At the time of enrolment and at 6 and 12 months. |
| Allodynia | The measurement of allodynia will be carried out with the Allodynia Symptom Checklist (ASC) 12 , a 12-item questionnaire regarding the frequency of presentation of various symptoms of allodynia in association with migraine attack. | At the time of enrolment and at 6 and 12 months. |
| Pain-related fear of movement | Pain-related fear of movement will be assessed by the Tampa Scale of Kinesiophobia | At the time of enrolment and at 6 and 12 months. |
| Patient's impression of how their pain condition | The patient's impression of how their pain condition has changed will be measured with the Patient Global Impression of Change (PGIC) questionnaire | At the time of enrolment and at 6 and 12 months. |
| Measures of patient's health-related quality of life | The 36-Item Short Form Survey (SF-36) evaluates eight health domains (physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), providing scores for both physical and mental health functioning. Each item is scored on a 0 to 100 range: a lower score indicates higher impairment and a higher score indicates better health. | At the time of enrolment and at 6 and 12 months. |
| Subjective psychological well-being over the past two weeks | Well-being status will be assessed with The World Health Organization-Five Well-Being Index (WHO-5). It measures positive mood, vitality, and general interest on a 0-5 scale, with higher scores indicating better well-being. | At the time of enrolment and at 6 and 12 months. |
| Sleep quality over the previous four weeks | Falling asleep, sleep continuity, sleep duration, sleepiness, and breathing disturbances during sleep will be assessed with the Sleep Scale from the Medical Outcomes Study (MOS) questionnaire. MOS assess 6 dimensions (sleep disturbance, adequacy, somnolence, snoring, and apnea). It provides 0-100 scores for each dimension: an higher scores mean better sleep. | At the time of enrolment and at 6 and 12 months. |
| Psychological symptoms | psychological symptoms will be studied using SCL-90 r, a 90-item questionnaire | At the time of enrolment and at 6 and 12 months. |
| Severity of depressive symptoms | Severity of depressive symptoms will be studied using the Beck Depression Inventory vers.II self-assessment scale. | At the time of enrolment and at 6 and 12 months. |
| Depression | Hamilton Rating Scale for Depression, a hetero-administered scale that assesses the severity of depressive symptoms, used both for clinical and research purposes (it consists of 21 multiple-choice questions) will be used to assess different domains, in particular anxiety/somatization, weight changes, cognitive disorders, diurnal variations of symptoms, slowing down, sleep disorders. A high score reflects more severe depressive symptoms. | At the time of enrolment and at 6 and 12 months. |
| Anxiety | Hamilton Rating Scale for Anxiety, a hetero-administered rating scale that measures the severity of anxiety symptoms, used both for clinical and research purposes (it consists of 14 items filled in by the clinician during the interview and on the basis of the patient's observation) will be used to study the anxiety. A high value reflects a more severe anxiety symptomatology. Moreover, we will use the Spielberger state-trait anxiety inventory (STAI-Y), a self-administered rating scale of the level of anxiety symptoms. The scale, which consists of 40 multiple-choice questions, operates a distinction between state anxiety and trait anxiety. | At the time of enrolment and at 6 and 12 months. |
| Hypomanic/manic symptoms | We wiil use Mania Rating Scale (MRS), a hetero-administered rating scale that assesses hypomanic/manic symptoms and their severity. It consists of 11 multiple-choice questions. A higher value reflects a greater severity of symptoms. | At the time of enrolment and at 6 and 12 months. |
| Mood Disorder | We will use the Mood Disorder Questionnaire (MDQ), a self-administered rating scale that assesses the probability of being affected by bipolar disorder: it consists of 17 multiple-choice questions. | At the time of enrolment and at 6 and 12 months. |
| Obsessive-compulsive disorder | Obsessive-Compulsive Inventory (OCI-R), a self-administered rating scale aimed at determining the diagnosis and severity of obsessive-compulsive disorder. The scale consists of 18 multiple-choice questions. A higher value reflects a higher severity of OCD. | At the time of enrolment and at 6 and 12 months. |
| Adherence to Mediterranean diet | Eating habits and adherence to the principles of the Mediterranean diet will be assessed by administering the 14-Item Mediterranean Diet Assessment Tool questionnaire. | At the time of enrolment and at 6 and 12 months. |
| Physical activity time | Physical activity (PA) will be estimated by administering the International Physical Activity Questionnaire (IPAQ) and collected as min/week. According to the IPAQ scoring manual, IPAQ data were converted into METs, assigning to each activity the conventionally accepted intensity levels: 3.3 METs for walking, 4 METs for moderate-intensity activity, and 8 METs for vigorous-intensity activity. For example, walking energy expenditure (MET-WALK) was derived by multiplying results from walking minutes × walking days × 3.3. Moreover, PA will be measured through accelerometers such as ActiGraph Wearable Devices - wGT3X-BT. | At the time of enrolment and at 6 and 12 months. |
| Aerobic capacity | Aerobic capacity will be estimated using the 6 Minutes Walking Test. | At the time of enrolment and at 6 and 12 months. |
| Hand Grip Strength | The Hand Grip Strength will be measured with DynX ® dynamometer. | At the time of enrolment and at 6 and 12 months. |
| Dynamic muscle strength | Dynamic muscle strength will be assessed by estimating one repetition maximum by submaximal upper and lower limb strength tests, performed at natural load or with the aid of isotonic machines, using Brzycki's 1-RM prediction equation. | At the time of enrolment and at 6 and 12 months. |
| Postural measurements | A physical, an instrumental, a functional, and a neuromotor examination will be conducted to assess postural measurements. The physical examination distinguishes between functional and dysfunctional, painful posture, with particular focus on the cervical spine. It assesses alterations such as hyperlordosis, straightening, or scoliosis, which may contribute to migraine onset. Head alignment is also evaluated, as muscle imbalances and thoracic or lumbar compensations can lead to neck pain and headaches. Instrumental assessment includes the Barré vertical test to identify postural syndromes and the Arrow test to evaluate sagittal spinal alterations. The functional exam analyzes joint mobility and muscle elasticity. The neuromotor assessment includes Fukuda, simple Romberg, monopodalic, sensitized test. | At the time of enrolment and at 6 and 12 months. |
| Pain associated with Temporomandibular Disorders | The Temporomandibular Disorders (TMD) Pain Screener is used to identify patients suffering from pain associated with TMD, focusing on jaw pain, pain upon awakening, and pain with jaw activities within the last 30 days. Responses are graded as 0=No pain; 1=Pain comes/goes; 2= Pain always present. An higher total points indicating a higher likelihood of TMD. | At the time of enrolment and at 6 and 12 months. |
| Migraine impact within the past four weeks | The Headache Impact Test-6 (HIT-6) is a short 6-item questionnaire used to assess the impact and severity of migraine on various domains (Pain severity, social functioning, role functioning (work/school), cognitive functioning, vitality, and psychological distress) of daily life, during the past four weeks. Each of six question is rated on a 5-point scale: Never=6; Rarely=8; Sometimes=10;Very Often=11; Always=13. The score is: <49=Little or no impact; 50-55=some impact;56-59=substantial impact;>60=Severe impact. | at the time of enrollment and at 6/12 months |
| Presence of Gnathology Symptoms | The Symptom Questionnaire is used by gnathologists to check (yes/no) a patient's symptoms, medical history, and parafunctional habits (like grinding) related to the temporomandibular joint, masticatory muscles, and dental occlusion. | at the time of enrollment and at 6/12 months |
| Functional analysis of dental occlusion | Teethan exam allow to evaluate the activity of the main masticatory muscles, anterior temporalis and masseters. It allows to identify any asymmetry, the intensity of muscle work, the torsional attitude of the mandible and the center of gravity, comparing temporalis activity with masseters activity. | At 6 and 12 month. |
| Psychological component of gnathologist exam | The psychological component will be assesse through:
| At 6 and 12 months |
| Insomnia | The presence of insomnia, as well as its severity, will be measured with the Insomnia Severity Index (ISI). It consists of 5 multiple-choice questions. Higher scores reflect greater severity of insomnia. | At 6 and 12 months. |
| Sleep time | Sleep time will be measured with the help of portable accelerometers of the ActiGraph Wearable Devices - wGT3X-BT type. | At 6 and 12 months. |
| Chronotype | The chronotype will be assessed with the Morningness-eveningness questionnaire (MEQ-SA) which is a self-report scale used to assess the patient's circadian phenotype. It consists of 19 questions per answer multiple. A high score reflects a morning chronotype while a lower score reflects a serotine chronotype. | At 6 and 12 months. |
| Blood pressure | Systolic and diastolic blood pressure (mmHg) values will be measured with a digital column sphygmomanometer for professional blood pressure measurement. | at the time of enrollment and at 6/12 months |
| Sitting time | Sitting time will be assessed using the International Physical Activity Questionnaire in Short Form (IPAQ-SF). Moreover, it will be recorded using a Wearable Devices (type ActiGraphwGT3X-BT). | At the time of enrollment and at 6/12 months |
| Sex | Biological sex of patients | at the time of enrollment and at 6/12 months |
| Years of illness | The length of time an illness has been present. | At the time of enrollment. |
| Migraine medications used by patients | Dose and type of symptomatic and prophylaxis drugs used by patients | At the time of enrollment, at 6 and 12 months |
| Presence of migraine with aura | The patient is queried about the presence or absence of migraine with or without aura. | At the time of enrollment, at 6 and 12 months |
| Glycated hemoglobin values | Percentage of Glycated hemoglobin (or HbA1c) | at the time of enrollment and at 6/12 months |
| Cholesterol and triglycerides values | Total cholesterol (mg/dL), HDL (mg/dL), LDL (mg/dL), triglycerides (mg/dL). | at the time of enrollment and at 6/12 months |
| C-reactive protein values | C-reactive protein (mg/dL). | at the time of enrollment and at 6/12 months |
| Risk of developing Coronary Heart Disease (CHD) | Percentage probability of a cardiovascular event (like a heart attack) occurring within a specific timeframe (usually 10 years). Risk levels are generally categorized as Low (<5%), Borderline (5% to <7.5%), Intermediate (7.5% to <20%), or High (≥20%) | at the time of enrollment and at 6/12 months |
| Body mass index (BMI) | Body mass index (kg/m2) will be calculated as weight (kg) divided by the square of height (meters). | at the time of enrollement and after 6 and 12 months |
| Fat and lean mass | Fat mass and lean mass (kg) assessed using BIA and Air plethysmography. | at the time of enrollement and after 6 and 12 months |
| Height | Height (m) assessed using a medical stadiometer. | at the time of enrollement and after 6 and 12 months |
| Waist circumference | Waist circumference (cm) will be measured using a medical tape | at the time of enrollement and after 6 and 12 months |
| Diet-related cardiometabolic risk Score | Diet-related cardiometabolic risk will be evaluated using the the 9-item Diet Risk Score (DRS). The DRS is a validated, screening tool used to identify individuals at high risk of cardiometabolic disease due to suboptimal diet, such as high sodium/sugar and low fibre intake. The scale utilised to evaluate the quality of dietary regimens ranges from 0 to 27, with 0 denoting a low risk profile and 27 signifying a high risk classification. | At the enrollment, and at 6 and 12 months. |
| Number of migraine attacks per month | The patient is requested to provide a quantitative estimation of the frequency with which they experience migraine attacks, specifying the number of such attacks occurring on a monthly basis. | At the time of enrollment, at 6 and 12 months |
| Intensity of the migraine episodes | The patient is asked to indicate the intensity of the migraine episodes, specifying if they are mild, moderate, or severe. | At the time of enrollment, at 6 and 12 months |
| Number of headache attacks per month | The patient is requested to provide a quantitative estimation of the frequency with which they experience headache, on a monthly basis. | At the time of enrollment, at 6 and 12 months |
| Perugia |
| PG |
| 06132 |
| Italy |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |