Clinical trial NCT07003711: Effects of Progressive Muscle Relaxation Training Applied in Addition to Aerobic Exercise Training in Individuals With Migraine Diagnosis
Official title: Effects of Progressive Muscle Relaxation Training Applied in Addition to Aerobic Exercise Training in Individuals With Migraine Diagnosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Migraine Disease
Keywords: aerobic exercise
physical therapy
therapy
migraine
relaxation
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants who meet the inclusion criteria will be randomly assigned to one of two groups: exercise or control group. The exercise group will be given both aerobic exercise and progressive muscle relaxation training. The control group will only receive aerobic exercise.
Primary purpose: TREATMENT

Brief summary: Aim: The purpose of this study is to evaluate the effects of progressive muscle relaxation training, in addition to aerobic exercise training, on pain, disability, quality of life, psychological status, and functional capacity in individuals diagnosed with migraine.

Methods: The study population comprises migraine patients who presented to the Neurology Clinic of Mardin Training and Research Hospital. Participants meeting the inclusion criteria will be randomized into two groups: an exercise group and a control group. The exercise group will receive both aerobic exercise and progressive muscle relaxation training, while the control group will receive only aerobic exercise. Participants' physical and demographic characteristics, as well as migraine-associated symptoms, will be assessed and recorded. Pain characteristics will be evaluated using a pain diary and pressure pain threshold measurements of the head and neck muscles. Disability will be assessed with the Migraine Disability Assessment Scale (MIDAS). Quality of life will be measured using the Headache Impact Test (HIT-6). Psychological status will be evaluated with the Hospital Anxiety and Depression Scale (HADS). Functional capacity will be assessed clinically using the 6-Minute Walk Test.

Detailed description: Participants in both groups will receive sessions under the supervision of a physiotherapist, three sessions per week for 12 weeks. The aerobic exercise program will consist of a warm-up, a main exercise phase (loading program), and a cool-down period. Progressive muscle relaxation training will be implemented as part of the relaxation training protocol.

Eligibility criteria: The inclusion criteria are listed as follows:

* Having been diagnosed with migraine by a specialist neurologist.
* Experiencing at least 3 migraine attacks per month.
* Being between the ages of 18 and 65.
* Volunteering to participate in the study.

Exclusion Criteria listed as follows:

* Being pregnant.
* Having any neurological disease other than migraine.
* Having other secondary headaches in addition to migraine.
* Having a recent history of head or neck trauma.
* Participating in a regular exercise program in the last 6 months.
* Having a history of malignancy.
* Having a disease or disability that may prevent aerobic exercise.

Primary outcomes:
measure: Migraine-Related Disability Status Questionnaire
timeFrame: 12 week (before and after treatment)
measure: Headache Impact Questionnaire (HIT-6)
timeFrame: 12 weeks (before and after treatment)
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 weeks (before and after treatment)
measure: 6 min Walking Test
timeFrame: 12 weeks (before and after treatment)
measure: pain diary
timeFrame: 20 weeks (4 weeks before treatment, 12 weeks during treatment, 4 weeks after treatment)
measure: pressure pain threshold assessment
timeFrame: 12 weeks (before and after treatment)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Şeyda TOPRAK ÇELENAY, professor
role: STUDY_DIRECTOR
References: