Migraine in AdultsEXEMIG/01NCT07508449

EXErcise in MIGraine

A study testing exercise program supervised by specialized kinesiologists and Standard neurological visit at the Headache Centre in people with Migraine in Adults, run by Centro Universitario Ricerca Interdipartimentale Attivita' Motoria at 2 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine in Adults
What is being tested?: exercise program supervised by specialized kinesiologists and Standard neurological visit at the Headache Centre
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 2 sitesItaly
Study dates: 3 Feb 2025to 3 Feb 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Migraine with and without aura.
Number of attacks month ≥ 8 and < 15 for episodic high-frequency patients and ≥ 15 for chronic migraine patients for at least 3 months.
Age 18 to 65 years at screening.
Physical inactivity (defined as insufficient amount of physical activity practiced according to current guidelines, i.e. <150 min./week).
Ability to walk independently at the time of assessment.

Who cannot join

Age < 18 years or older than 65 years;
clinical evidence of significant cardiovascular, central nervous system, and musculoskeletal disease that may limit or contraindicate exercise practice.
Failure to give consent to the study.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

CURIAMo
Perugia, PG, 06126
Centro Cefalee c/o Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
Perugia, PG, 06132

Other trials in Italy

About this study

Official title: Study of the Effects of a Multidisciplinary Intervention -Including Physical Exercise- in People With High-frequency Episodic Migraine and Chronic Migraine

Read the detailed description

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:

- specialist visit at the Headache Centre;
a - anthropometric, metabolic, and dietary assessment;

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:

Group 1, n° 70 people with migraine in standard treatment (control arm).
Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised by specialized kinesiologists (intervention arm).

Conditions: Migraine in Adults
Being tested: exercise program supervised by specialized kinesiologists, Standard neurological visit at the Headache Centre
Keywords: migraine, exercise, interdisciplinary approach
Medical subject headings: Migraine Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exercise program supervised by specialized kinesiologistsBehavioural
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.
Standard neurological visit at the Headache CentreOther
Participants will be invited to participate a:
1. - specialist visit at the Headache Centre;
2. a - anthropometric, metabolic, and dietary assessment;
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.

Study groups in NCT07508449
Study group	Role	What they receive
Group 1, 70 people with migraine in standard treatment (control arm).	Active comparator	Standard care Receives: Other: Standard neurological visit at the Headache Centre
Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised	Experimental	Standard care plus supervised exercise program Receives: Behavioral: exercise program supervised by specialized kinesiologists; Other: Standard neurological visit at the Headache Centre

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of migraine attacks/month and Physical Activity levels
Relationships between lifestyle (in particular Physical Activity levels, and the number of migraine attacks/month
Measured: From the time of enrollment and at 6/12 months

Secondary outcomes (50)

Age
Number of years of patients
Measured: At the time of enrollment
Blood glucose value
Blood glucose (mg/dL) of the patients.
Measured: at the time of enrollment and at 6/12 months
Weight
Weight (kg) assessed using a calibrate medical scale;
Measured: 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+
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of enrolment and at 6 and 12 months.
Aerobic capacity
Aerobic capacity will be estimated using the 6 Minutes Walking Test.
Measured: At the time of enrolment and at 6 and 12 months.
Hand Grip Strength
The Hand Grip Strength will be measured with DynX ® dynamometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 and 12 month.
Psychological component of gnathologist exam
The psychological component will be assesse through:
- the Graded Chronic Pain Scale (GCPS);
- the Mandibular Functional Limitation Scale (JFLS-8);
- the Patient Health Questionnaire (PHQ-4);
- the Oral Behaviors Checklist (OBC).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At the time of enrollment and at 6/12 months
Sex
Biological sex of patients
Measured: at the time of enrollment and at 6/12 months
Years of illness
The length of time an illness has been present.
Measured: At the time of enrollment.
Migraine medications used by patients
Dose and type of symptomatic and prophylaxis drugs used by patients
Measured: 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.
Measured: At the time of enrollment, at 6 and 12 months
Glycated hemoglobin values
Percentage of Glycated hemoglobin (or HbA1c)
Measured: 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).
Measured: at the time of enrollment and at 6/12 months
C-reactive protein values
C-reactive protein (mg/dL).
Measured: 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%)
Measured: 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).
Measured: 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.
Measured: at the time of enrollement and after 6 and 12 months
Height
Height (m) assessed using a medical stadiometer.
Measured: at the time of enrollement and after 6 and 12 months
Waist circumference
Waist circumference (cm) will be measured using a medical tape
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of enrollment, at 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20253 Feb 2027

First posted2 Apr 2026
Study start3 Feb 2025
Primary completion3 May 2026 (estimated)
Study completion3 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Migraine in AdultsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two arms, randomized, controlled study
Masking: None (open label)
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07508449
Sponsor's protocol ID: CET N.4807/24.
Acronym: EXEMIG/01
Status last verified: Mar 2026
First submitted: 12 Feb 2026
Last updated: 2 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
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RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
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RecruitingPhase 4
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RecruitingPhase 4
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RecruitingPhase 3
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All Migraine in Adults trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Effects of a Multidisciplinary Intervention -Including Physical Exercise- in People With High-frequency Episodic Migraine and Chronic Migraine
ClinicalTrials.gov ID: NCT07508449
Acronym / sponsor ID: EXEMIG/01 / CET N.4807/24.
Conditions: Migraine in Adults
Keywords: migraine, exercise, interdisciplinary approach
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: Centro Universitario Ricerca Interdipartimentale Attivita' MotoriaUniversity, hospital or other
Collaborators: University Of Perugia, University Hospital Perugia
Study start: 3 Feb 2025 (actual)
Primary completion: 3 May 2026 (estimated)
Study completion: 3 Feb 2027 (estimated)
First posted: 2 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All study participants will be invited to participate a:

- specialist visit at the Headache Centre;
a - anthropometric, metabolic, and dietary assessment;

According to a randomized allocation, participants will be assigned to two groups:

Group 1, n° 70 people with migraine in standard treatment (control arm).
Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised by specialized kinesiologists (intervention arm).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Two arms, randomized, controlled study

Arm	Type	Receives
Group 1, 70 people with migraine in standard treatment (control arm).	Active comparator	Other: Standard neurological visit at the Headache CentreStandard care
Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised	Experimental	Behavioral: exercise program supervised by specialized kinesiologists, Other: Standard neurological visit at the Headache CentreStandard care plus supervised exercise program

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Migraine with and without aura.
Number of attacks month ≥ 8 and < 15 for episodic high-frequency patients and ≥ 15 for chronic migraine patients for at least 3 months.
Age 18 to 65 years at screening.
Physical inactivity (defined as insufficient amount of physical activity practiced according to current guidelines, i.e. <150 min./week).
Ability to walk independently at the time of assessment.

Key exclusion criteria (3 listed)

Age < 18 years or older than 65 years;
clinical evidence of significant cardiovascular, central nervous system, and musculoskeletal disease that may limit or contraindicate exercise practice.
Failure to give consent to the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exercise program supervised by specialized kinesiologistsThe 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.	Behavioural	Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised
Standard neurological visit at the Headache CentreParticipants will be invited to participate a: 1. - specialist visit at the Headache Centre; 2. a - anthropometric, metabolic, and dietary assessment; 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.	Other	Group 1, 70 people with migraine in standard treatment (control arm)., Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised

Primary outcome

Number of migraine attacks/month and Physical Activity levels
Time frame: From the time of enrollment and at 6/12 months
Relationships between lifestyle (in particular Physical Activity levels, and the number of migraine attacks/month

50 secondary outcomes

Age
Time frame: At the time of enrollment
Blood glucose value
Time frame: at the time of enrollment and at 6/12 months
Weight
Time frame: at the time of enrollement and after 6 and 12 months
Days lost or limited in activities over 3 months for migraine
Time frame: at the time of enrollment and at 6/12 months
Impact of migraine on daily life
Time frame: At the time of enrolment and at 6 and 12 months.
Allodynia
Time frame: At the time of enrolment and at 6 and 12 months.
Pain-related fear of movement
Time frame: At the time of enrolment and at 6 and 12 months.
Patient's impression of how their pain condition
Time frame: At the time of enrolment and at 6 and 12 months.
Measures of patient's health-related quality of life
Time frame: At the time of enrolment and at 6 and 12 months.
Subjective psychological well-being over the past two weeks
Time frame: At the time of enrolment and at 6 and 12 months.
Sleep quality over the previous four weeks
Time frame: At the time of enrolment and at 6 and 12 months.
Psychological symptoms
Time frame: At the time of enrolment and at 6 and 12 months.
Severity of depressive symptoms
Time frame: At the time of enrolment and at 6 and 12 months.
Depression
Time frame: At the time of enrolment and at 6 and 12 months.
Anxiety
Time frame: At the time of enrolment and at 6 and 12 months.
Hypomanic/manic symptoms
Time frame: At the time of enrolment and at 6 and 12 months.
Mood Disorder
Time frame: At the time of enrolment and at 6 and 12 months.
Obsessive-compulsive disorder
Time frame: At the time of enrolment and at 6 and 12 months.
Adherence to Mediterranean diet
Time frame: At the time of enrolment and at 6 and 12 months.
Physical activity time
Time frame: At the time of enrolment and at 6 and 12 months.
Aerobic capacity
Time frame: At the time of enrolment and at 6 and 12 months.
Hand Grip Strength
Time frame: At the time of enrolment and at 6 and 12 months.
Dynamic muscle strength
Time frame: At the time of enrolment and at 6 and 12 months.
Postural measurements
Time frame: At the time of enrolment and at 6 and 12 months.
Pain associated with Temporomandibular Disorders
Time frame: At the time of enrolment and at 6 and 12 months.
Migraine impact within the past four weeks
Time frame: at the time of enrollment and at 6/12 months
Presence of Gnathology Symptoms
Time frame: at the time of enrollment and at 6/12 months
Functional analysis of dental occlusion
Time frame: At 6 and 12 month.
Psychological component of gnathologist exam
Time frame: At 6 and 12 months
Insomnia
Time frame: At 6 and 12 months.
Sleep time
Time frame: At 6 and 12 months.
Chronotype
Time frame: At 6 and 12 months.
Blood pressure
Time frame: at the time of enrollment and at 6/12 months
Sitting time
Time frame: At the time of enrollment and at 6/12 months
Sex
Time frame: at the time of enrollment and at 6/12 months
Years of illness
Time frame: At the time of enrollment.
Migraine medications used by patients
Time frame: At the time of enrollment, at 6 and 12 months
Presence of migraine with aura
Time frame: At the time of enrollment, at 6 and 12 months
Glycated hemoglobin values
Time frame: at the time of enrollment and at 6/12 months
Cholesterol and triglycerides values
Time frame: at the time of enrollment and at 6/12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Individual participant dataSharing planned: No

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Acute Treatment of Migraine
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine
Preventive Treatment of Migraine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paola Sarchielli principal investigator

Centro Cefalee dell'Azienda Ospedaliera di Perugia

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of migraine attacks/month and Physical Activity levels (time frame: From the time of enrollment and at 6/12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07508449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.