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Clinical Trials/NCT05741775
NCT05741775
Recruiting
Phase 3

Efficacy of Physiotherapy Intervention Among University Students With Migraine Symptoms

Universiti Tunku Abdul Rahman1 site in 1 country87 target enrollmentSeptember 18, 2022
ConditionsMigraine

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Migraine
Sponsor
Universiti Tunku Abdul Rahman
Enrollment
87
Locations
1
Primary Endpoint
resting-state EEG
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this randomized control trial is to analyse the effectiveness of Physiotherapy intervention among university students with migraine symptoms. The main objective is:

  1. To determine the effect of aerobic exercise on the resting-state brainwaves among university students in UTAR with migraine symptoms compared with biofeedback and control exercise.
  2. To analyse the influence of aerobic exercise on the sleep quality and quality of life among the cohort compared with biofeedback and control exercise.

Although the Migraine Research Foundation listed three main types of non-drug treatments for migraine are lifestyle advice, therapies, and exercises. Some common aerobic exercises such as walking, jogging, a behavioral weight loss program, cycling, and a combination of cross-training, walking, jogging, and cycling are suggested to be beneficial to the migraine patients but there remains no specific protocol established till now. Hence the other main objective of this is to establish a aerobic exercise protocol for patients with migraine symptoms.

Detailed Description

Habitual aerobic exercise has a major advantage of preventing or reducing symptoms of several chronic diseases and medical conditions. Aerobic or cardiovascular exercise by definition is a form of bodily movement that is fueled by aerobic energy-generating processes, where the energy demands of the exercise performed do not exceed the rate at which the cardiovascular system can supply oxygen to working muscles. Aerobic exercises have already proven to reduce frequency, duration, severity or associated disability in migraine. The physiology is that when one exercises, the body releases endorphins, which are the body's natural painkillers and natural anti-depressants chemicals called enkephalins. According to Centre of Disease Control and Prevention (CDC), adult should exercise 150 minutes of moderate intensity aerobic exercise and 2 or more days a week of muscle strengthening each week for relief of migraine or primary headaches. Similarly, a study conducted comparing neck treatment and aerobic exercise concluded that 5 weeks of intervention for migraine patient responded with better outcomes. According to American migraine foundation the exercise program, should include the cardiorespiratory fitness, flexibility exercises and muscular strengthening. For this reason, several studies encourage a multidisciplinary and tailored treatment approach for these patients. Hence the study aim to assess the efficacy of physiotherapy intervention especially aerobic exercise among university students with migraine symptoms.

Registry
clinicaltrials.gov
Start Date
September 18, 2022
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kiruthika Selvakumar

Principle Investigator (Lecturer)

Universiti Tunku Abdul Rahman

Eligibility Criteria

Inclusion Criteria

  • Undergraduate, and postgraduate students from Universiti Tunku Abdul Rahman
  • 4 of 5 on the Migraine Screen Questionnaire

Exclusion Criteria

  • Score of more than or equal to 5 on the visual aura rating scale,
  • Diagnosed to have a secondary headache (headache attributed to the causative disorder example: infection, trauma, injury to head/ or neck)
  • Pregnancy,
  • Took medication for neurological conditions like stroke, multiple sclerosis and took medications for cardiorespiratory conditions like asthma,
  • Took medications for headache and
  • Unwilling to participate will be excluded

Outcomes

Primary Outcomes

resting-state EEG

Time Frame: 20 minutes

Recording of resting-state EEG will be performed using MUSE 2 a portable EEG recording device. The headset has four dry sensors (two mastoid and two forehead sensors) and fits over the ears and extends at an angle over the middle of the forehead when properly fitted with 3 reference electrodes. Once the headband is fitted, the mind monitor app will be used for data acquisition. The data obtained will be imported to MATLAB using EEGLAB function plugins (muse monitor app) CSV file. Once imported the pre-processing steps will be done to run Independent Component Analysis (ICA). Amplitude and frequency, frequency band ratio, power spectrum density and coherence will be the primary measurement analyzed for the resting-state EEG recording,

Secondary Outcomes

  • Pittsburgh Sleep index(10 minutes)
  • Health survey questionnaire(5 minutes)
  • Migraine Specific Quality of life(10 minutes)

Study Sites (1)

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