EXErcise in MIGraine

NCT07508449 | Active Not Recruiting

• 1 other identifier: CET N.4807/24.
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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 skills of Neurology Specialists and those of CURIAMo.

Conditions

Migraine in Adults

Keywords

migraine; exercise; interdisciplinary approach

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (50)

• Age

  At the time of enrollment

• Blood glucose value

  at the time of enrollment and at 6/12 months

• Weight

  at the time of enrollement and after 6 and 12 months

• Days lost or limited in activities over 3 months for migraine

  at the time of enrollment and at 6/12 months

• Impact of migraine on daily life

  At the time of enrolment and at 6 and 12 months.

Study Arms (2)

Group 1, 70 people with migraine in standard treatment (control arm).

ACTIVE COMPARATOR

Standard care

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

Behavioral: exercise program supervised by specialized kinesiologists; Other: Standard neurological visit at the Headache Centre

Interventions

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.

Group 2, n° 70 people with migraine in standard treatment + adapted exercise program supervised

Standard neurological visit at the Headache Centre OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario Ricerca Interdipartimentale Attivita' Motoria: lead
• University Of Perugia: collaborator
• University Hospital Perugia: collaborator

Study Sites (2)

CURIAMo

Perugia, PG, 06126, Italy

Location

Centro Cefalee c/o Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia

Perugia, PG, 06132, Italy

Location

MeSH Terms

Conditions

Migraine Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Paola Sarchielli

  Centro Cefalee dell'Azienda Ospedaliera di Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms, randomized, controlled study

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: April 2, 2026
• Study Start: February 3, 2025
• Primary Completion: May 3, 2026
• Study Completion (Estimated): February 3, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)