Clinical trial NCT06716489: Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine
Official title: Influence of Aerobic Exercise on Sensory Perception, Musculoskeletal and Psychosocial Alterations in Patients with Migraine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Migraine Disease
Migraine Disorder
Migraine Disorders, Brain
Headache
Headache (Migraine)
Headache Disorders
Headache Disorders, Primary
Aerobic Exercise
Pain Management
Sensory Disorders
Psychosocial Factors
Neck Pain
Quality of Life
Keywords: migraine
aerobic exercise
sensory perception
exercise
headache
disability
musculoeskeletal alterations
quality of life
neck pain
cervical pain
Sensory Thresholds
Psychosocial Factors
Physical Fitness
Exercise Intervention
Central Sensitization
Physical Therapy
Migraine Management
Non-pharmacological Treatment
Clinical Trial
Headache Relief
sensitization
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Migraine is a complex neurological disorder often associated with high levels of disability and alterations in the sensory and musculoskeletal systems. Aerobic exercise is a promising non-pharmacological treatment that may help reduce the frequency and severity of migraine attacks, but its effects on sensory perception and musculoskeletal changes in patients with migraine remain unclear.

This study will evaluate the effects of a 16-week aerobic exercise program on sensory perception, musculoskeletal alterations, and psychosocial factors in women aged 18-40 years old diagnosed with migraine. Participants will undergo assessments of headache-related disability, neck pain, physical fitness, neck performance, balance, and sensory thresholds, among other clinical and physical tests.

The exercise program includes treadmill sessions three times per week, with individualized intensity based on cardiovascular assessments. Expected outcomes include reduced headache disability, improved sensory and musculoskeletal parameters, and improved overall quality of life. This study aims to explore the feasibility of future clinical trials and provide evidence for accessible and low-risk treatment options for migraine management.

Detailed description: Background: Migraine can be considered a disease of the sensory system. These patients have a high level of disability due to the complexity of the disease. Currently, there are several non-pharmacological treatments, including physical exercise, especially aerobic exercise, which aims to reduce the frequency and intensity of attacks. However, the effects of aerobic exercise on the sensory and musculoskeletal changes that these patients present are not known. Objectives: To examine the effects of an aerobic exercise program on sensory perception, musculoskeletal changes, and psychosocial factors in patients with migraine. Methods: Sixty-eight women diagnosed with migraine between the ages of 18 and 40 will be selected and their anthropometric and clinical characteristics and questionnaires will be collected to assess disability related to headache and neck pain, quality of life, level of physical activity, kinesiophobia, cutaneous allodynia, central sensitization, migraine-related symptoms, self-efficacy and patient perception of global change. Physical tests include assessment of cervical strength, cervical range of motion, cervical endurance, flexion rotation test (FRT), craniocervical flexion test (CCFT), joint position error (JPE), thermal sensitivity threshold and mechanical pain by pressure pain threshold, balance by sensory organization test (SOT), two-point discrimination, Borg scale, and ergospirometry test. A 16-week aerobic training protocol will be performed on a treadmill, 3 times per week, with intensity adjusted for each patient according to cardiovascular assessment. Expected results: The training protocol is expected to be able to reduce headache-related disability, increase sensory thresholds, and improve musculoskeletal changes and overall quality of life in these patients, in addition to verifying the feasibility of conducting a future clinical trial with this group varying the exercise protocol.

Eligibility criteria: Inclusion Criteria:

* Women aged between 18 and 40 years.
* Diagnosed with migraine by an experienced neurologist specialized in headaches, following the criteria of the International Classification of Headache Disorders (ICHD).
* Frequency of headache between 3 and 8 days per month, to ensure adherence to the treatment.

Exclusion Criteria:

* Presence of any other type of concurrent headache.
* Medical conditions affecting sensitivity and autonomic modulation, such as peripheral neuropathies, autonomic disorders, severe neurological diseases, and others.
* Conditions that prevent physical activity, such as severe musculoskeletal injuries, cardiovascular diseases, or related conditions.
* Premature ovarian failure.
* Regular physical exercise in the past year.
* Body Mass Index (BMI) above 30.0.
* Smokers or individuals using drugs that interfere with sensitivity and cardiac modulation (e.g., beta-blockers).
* Abuse of abortive medications.

Primary outcomes:
measure: Thermal sensory threshold
timeFrame: 16 weeks (the duration of the intervention, with assessments made before and after the 16-week aerobic exercise program).
measure: Pressure pain threshold
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Cutaneous allodynia
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Headache-related disability
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
Secondary outcomes:
measure: Quality of Life
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Neck Pain Disability
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Physical Activity Level
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Perceived Global Change
timeFrame: 16 weeks (measured after the 16-week intervention period).
measure: Self-efficacy
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Neck Strength
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Two-point discrimination test
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Cardiovascular Performance (Cardiopulmonary Exercise Test)
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Balance (Sensory Organization Test)
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Kinesiophobia
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Central sensitization
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Cervical range of motion
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Neck endurance
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Upper cervical range of motion
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Performance of deep flexor cervical muscles
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
measure: Cervical proprioception
timeFrame: 16 weeks (measured before and after the 16-week intervention period).
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Ribeirão Preto Medical School - University of São Paulo (FMRP-USP)
state: São Paulo
Study officials:
References: