MigraineNCT07003711
Effects of Progressive Muscle Relaxation Training Applied in Addition to Aerobic Exercise Training in Individuals With Migraine Diagnosis
A study testing aerobic exercise and relaxation trainig and aerobic exercise in people with Migraine and Migraine Disease, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Migraine Disease
- What is being tested?
- aerobic exercise and relaxation trainig and aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Artuklu Eğitim Araştırma Hastanesi
Mardin, Artuklu, 470000
About this study
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.
Read the 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.
- Conditions
- Migraine, Migraine Disease
- Being tested
- aerobic exercise and relaxation trainig, aerobic exercise
- Keywords
- aerobic exercise, physical therapy, therapy, migraine, relaxation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise and relaxation trainigOther
Aerobic exercise and progressive muscle relaxation training will be given to the exercise group.
aerobic exerciseOther
Aerobic exercise will be applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The exercise group will receive aerobic exercise and progressive muscle relaxation training. Receives: Other: aerobic exercise and relaxation trainig |
| Control Group | Active comparator | The control group will receive aerobic exercise. Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine-Related Disability Status Questionnaire
The Migraine Disability Assessment Scale (MİDAS) will be used to determine the level of inadequacies in daily activities of individuals with migraine. MIDAS is a scale that aims to evaluate the disability status related to headache and the functionality of individuals with migraine in daily and social activities. The MIDAS scale includes 5 questions regarding workplace, school, home work and social relationships.
Measured: 12 week (before and after treatment)
Headache Impact Questionnaire (HIT-6)
The Headache Impact Questionnaire (HIT-6) will be used to assess the quality of life due to headache in individuals with migraine. The Turkish validity and reliability of the scale was performed by Dikmen and colleagues. It consists of 6 questions including the frequency of headache, the ability to carry out daily activities due to headache, the degree of limitation in social life, the need for rest, and the change in mood. This scale can be scored between 36 and 78. Higher scores on this scale indicate that the individual's quality of life is affected.
Measured: 12 weeks (before and after treatment)
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed to determine the risk of anxiety and depression and to measure the level and severity of change. The Turkish version of the scale was found to be valid and reliable. HADS is a 14-item self-assessment scale used to evaluate anxiety and depression levels. It consists of two subscales-7 items each for anxiety (HADS-A) and depression (HADS-D), scored from 0 to 21 (0-7 normal, 8-10 mild, 11-14 moderate, 15-21 severe). Higher scores indicate higher levels of anxiety or depression.
Measured: 12 weeks (before and after treatment)
6 min Walking Test
The 6-minute walk test is used as a simple measure of aerobic exercise capacity. The test involves walking on a flat surface for 6 minutes according to a standardized protocol. The distance walked before and after the 6-minute test will be recorded in meters.
Measured: 12 weeks (before and after treatment)
pain diary
Pain diaries are considered the gold standard for individuals with headaches. The severity of headaches during attacks, their duration (minutes), frequency, possible triggering factors, and the amount and type of medication taken will be recorded. The average pain intensity during headache attacks experienced by individuals with migraine in the last month will be assessed using the Numerical Pain Rating Scale (NADS), which has a score between 0 and 10 .
Measured: 20 weeks (4 weeks before treatment, 12 weeks during treatment, 4 weeks after treatment)
pressure pain threshold assessment
The pressure algometer is recognized as an objective method for assessing pain threshold. A pressure of approximately 1 kg/cm² will be applied to designated motor points of the muscles using the disk head of the algometer device, positioned at a 90-degree angle perpendicular to the skin. Participants will be instructed to say "stop" at the moment they first perceive pain. To ensure participant adaptation prior to the actual test, three consecutive measurements will be conducted for each muscle, with a 1-minute interval between measurements, and the average score will be calculated.
Measured: 12 weeks (before and after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start25 May 2025
- Primary completion10 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafize ALTAY, Mardin Artuklu University
- Investigators
- Şeyda TOPRAK ÇELENAY, professor, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003711
- Sponsor's protocol ID
- 2024/7-8
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data cannot be shared as it will contain personal information.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Muscle Relaxation Training Applied in Addition to Aerobic Exercise Training in Individuals With Migraine Diagnosis
- ClinicalTrials.gov ID
- NCT07003711
- Acronym / sponsor ID
- 2024/7-8
- Conditions
- Migraine, Migraine Disease
- Keywords
- aerobic exercise, physical therapy, therapy, migraine, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: aerobic exercise and relaxation trainigThe exercise group will receive aerobic exercise and progressive muscle relaxation training. |
| Control Group | Active comparator | Other: aerobic exerciseThe control group will receive aerobic exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise and relaxation trainigAerobic exercise and progressive muscle relaxation training will be given to the exercise group. | Other | Exercise Group |
| aerobic exerciseAerobic exercise will be applied to the control group. | Other | Control Group |
Primary outcome
Migraine-Related Disability Status Questionnaire
Time frame: 12 week (before and after treatment)
The Migraine Disability Assessment Scale (MİDAS) will be used to determine the level of inadequacies in daily activities of individuals with migraine. MIDAS is a scale that aims to evaluate the disability status related to headache and the functionality of individuals with migraine in daily and social activities. The MIDAS scale includes 5 questions regarding workplace, school, home work and social relationships.
Headache Impact Questionnaire (HIT-6)
Time frame: 12 weeks (before and after treatment)
The Headache Impact Questionnaire (HIT-6) will be used to assess the quality of life due to headache in individuals with migraine. The Turkish validity and reliability of the scale was performed by Dikmen and colleagues. It consists of 6 questions including the frequency of headache, the ability to carry out daily activities due to headache, the degree of limitation in social life, the need for rest, and the change in mood. This scale can be scored between 36 and 78. Higher scores on this scale indicate that the individual's quality of life is affected.
Hospital Anxiety and Depression Scale
Time frame: 12 weeks (before and after treatment)
Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed to determine the risk of anxiety and depression and to measure the level and severity of change. The Turkish version of the scale was found to be valid and reliable. HADS is a 14-item self-assessment scale used to evaluate anxiety and depression levels. It consists of two subscales-7 items each for anxiety (HADS-A) and depression (HADS-D), scored from 0 to 21 (0-7 normal, 8-10 mild, 11-14 moderate, 15-21 severe). Higher scores indicate higher levels of anxiety or depression.
6 min Walking Test
Time frame: 12 weeks (before and after treatment)
The 6-minute walk test is used as a simple measure of aerobic exercise capacity. The test involves walking on a flat surface for 6 minutes according to a standardized protocol. The distance walked before and after the 6-minute test will be recorded in meters.
pain diary
Time frame: 20 weeks (4 weeks before treatment, 12 weeks during treatment, 4 weeks after treatment)
Pain diaries are considered the gold standard for individuals with headaches. The severity of headaches during attacks, their duration (minutes), frequency, possible triggering factors, and the amount and type of medication taken will be recorded. The average pain intensity during headache attacks experienced by individuals with migraine in the last month will be assessed using the Numerical Pain Rating Scale (NADS), which has a score between 0 and 10 .
pressure pain threshold assessment
Time frame: 12 weeks (before and after treatment)
The pressure algometer is recognized as an objective method for assessing pain threshold. A pressure of approximately 1 kg/cm² will be applied to designated motor points of the muscles using the disk head of the algometer device, positioned at a 90-degree angle perpendicular to the skin. Participants will be instructed to say "stop" at the moment they first perceive pain. To ensure participant adaptation prior to the actual test, three consecutive measurements will be conducted for each muscle, with a 1-minute interval between measurements, and the average score will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Study data cannot be shared as it will contain personal information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyda TOPRAK ÇELENAY, professor study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and relaxation trainig and aerobic exercise in people with Migraine and Migraine Disease, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine-Related Disability Status Questionnaire (time frame: 12 week (before and after treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.