NCT07508449

EXErcise in MIGraine

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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: 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. 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

Interventions

Type	Name	Description
BEHAVIORAL	exercise program supervised by specialized kinesiologists	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.
OTHER	Standard neurological visit at the Headache Centre	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.

Timeline

• Start date: 2025-02-03
• Primary completion: 2026-05-03
• Completion: 2027-02-03
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

2 sites across 1 country: Italy