Chronic Migraine, Migraine
Conditions
Keywords
Headache, Exercise, Resistance exercises, Aerobic exercise
Brief summary
The purpose of this study is to evaluate and compare the effect of different exercise types and combinations on migraine attacks in patients with migraine.
Interventions
BEHAVIORALCombined exercise
aerobic plus resistance exercise
BEHAVIORALAerobic exercise
Only aerobic exercise
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of migraine confirmed by a specialist neurologist according to International Classification of Headache Disorders, 3rd version(ICHD-3) * Diagnosed as chronic migraine at the time of initial diagnosis (may have turned into episodic migraine under preventive treatment) * At least 5 migraine attack/month in baseline diary * No obstacle to exercise in the evaluation made with physical examination and ECG * Diagnosed with migraine for at least 12 months * Between the ages of 18-50
Exclusion criteria
* Exercising regularly in the last 6 months * Presence of concomitant internal and neurological diseases * Anti-psychotic drug use * Drug, alcohol addiction * Pregnancy, breastfeeding * Patients who cannot reach the targeted exercise level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Days With Migraine (in Migraine Frequency) | Baseline and Week 12 and Week 20 | Defined as the number of days with a migraine headache in a month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Baseline and Week 12 and Week 20 | Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscale . Higher points are associated with worse anxiety or depression |
| Depression | Baseline and Week 12 and Week 20 | Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscales . Higher points are associated with worse anxiety or depression |
| Average Intensity of Headache | Baseline and Week 12 and Week 20 | A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache |
| Aerobic Capacity Measurement V02 Max | Baseline and Week 12 and Week 20 | Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity. |
| Change in Physical Activity Level | Baseline and Week 12 and Week 20 | The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity |
| Migraine Specific Quality of Life | Baseline and Week 12 and Week 20 | Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper or lower limit on scoring. More than 21 points show severe disability. Higher points mean more disability.MIDAS Grade/ MIDAS Score: Little or No Disability 0-5 , Mild Disability 6-10 , Moderate Disability 11-20 , Severe Disability 21+ |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants who applied to Ege University Hospital Neurology Department of Headache policlinic were recruited based on neurology physician up to International Headache Disorder Classification 3rd version (ICHD-3). Participants were enrolled to study between November 2022- January 2024.
Pre-assignment details
Of 32 enrolled participants , 24 participants filled out baseline headache diaries regularly and were randomized to groups
Participants by arm
| Arm | Count |
|---|---|
| Combined Exercise Group Aerobic plus resistance exercise intervention
Combined exercise: aerobic plus resistance exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes During this time patients did five different resistance exercise with elastic bands three times a week. Participants started resistance exercises with 2 sets of 8 repetitions, with a gradual increase until 3 sets of 12 repetitions were reached at the end of the first month. | 8 |
| Aerobic Exercise Group Only aerobic exercise intervention
Aerobic exercise: Only aerobic exercise For 12 weeks participants did aerobic exercise 3 times a week. One session took 45 minutes | 8 |
| Control Group no intervention | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Combined Exercise Group | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 13 | 36 years STANDARD_DEVIATION 11 | 44 years STANDARD_DEVIATION 5 | 39.8 years STANDARD_DEVIATION 10.3 |
| Beta blocker use | 4 Participants | 5 Participants | 6 Participants | 15 Participants |
| Body mass index | 26.60 kilogram/square meter STANDARD_DEVIATION 3.46 | 25.50 kilogram/square meter STANDARD_DEVIATION 3.84 | 28.45 kilogram/square meter STANDARD_DEVIATION 5.15 | 26.85 kilogram/square meter STANDARD_DEVIATION 4.21 |
| Body weight | 74 kilogram STANDARD_DEVIATION 14 | 68 kilogram STANDARD_DEVIATION 10 | 75 kilogram STANDARD_DEVIATION 12 | 71.9 kilogram STANDARD_DEVIATION 12.12 |
| Height | 166 centimeter STANDARD_DEVIATION 10 | 163 centimeter STANDARD_DEVIATION 5 | 162 centimeter STANDARD_DEVIATION 2 | 163.5 centimeter STANDARD_DEVIATION 6.35 |
| Migraine duration | 13.2 years STANDARD_DEVIATION 12.9 | 8.5 years STANDARD_DEVIATION 10 | 16.8 years STANDARD_DEVIATION 7.8 | 12.8 years STANDARD_DEVIATION 10.5 |
| Number of participants using medication for migraine attack treatment(triptan) | 5 participants | 7 participants | 7 participants | 19 participants |
| Number of Participants with Migraine Aura | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Preventive drugs number | 1 mean number of medication used STANDARD_DEVIATION 1 | 1 mean number of medication used STANDARD_DEVIATION 1 | 1 mean number of medication used STANDARD_DEVIATION 0 | 1 mean number of medication used STANDARD_DEVIATION 0.48 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Serotonin and norepinephrine reuptake inhibitors (SNRIs) use | 5 Participants | 2 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Tricyclic antidepressants (TCAs) | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Change in the Number of Days With Migraine (in Migraine Frequency)
Defined as the number of days with a migraine headache in a month
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Change in the Number of Days With Migraine (in Migraine Frequency) | End of 12 weeks(Post intervention) | 6.3 days/month | Standard Deviation 3.4 |
| Combined Exercise Group | Change in the Number of Days With Migraine (in Migraine Frequency) | Baseline | 9.9 days/month | Standard Deviation 4.2 |
| Combined Exercise Group | Change in the Number of Days With Migraine (in Migraine Frequency) | End of 8 weeks (follow up) | 6.5 days/month | Standard Deviation 3.4 |
| Aerobic Exercise Group | Change in the Number of Days With Migraine (in Migraine Frequency) | End of 12 weeks(Post intervention) | 8 days/month | Standard Deviation 4.5 |
| Aerobic Exercise Group | Change in the Number of Days With Migraine (in Migraine Frequency) | Baseline | 12.4 days/month | Standard Deviation 4.5 |
| Aerobic Exercise Group | Change in the Number of Days With Migraine (in Migraine Frequency) | End of 8 weeks (follow up) | 8.8 days/month | Standard Deviation 4.1 |
| Control Group | Change in the Number of Days With Migraine (in Migraine Frequency) | Baseline | 11.8 days/month | Standard Deviation 3.4 |
| Control Group | Change in the Number of Days With Migraine (in Migraine Frequency) | End of 8 weeks (follow up) | 10.6 days/month | Standard Deviation 3.2 |
| Control Group | Change in the Number of Days With Migraine (in Migraine Frequency) | End of 12 weeks(Post intervention) | 10.6 days/month | Standard Deviation 2.3 |
p-value: 0.001ANOVA
Comparison: A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.p-value: 0.001ANOVA
p-value: 0.166ANOVA
Secondary
Aerobic Capacity Measurement V02 Max
Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Aerobic Capacity Measurement V02 Max | Baseline | 30.1 mililiter/kilogram/minute | Standard Deviation 3 |
| Combined Exercise Group | Aerobic Capacity Measurement V02 Max | Week 20 (follow up) | 32.1 mililiter/kilogram/minute | Standard Deviation 3.6 |
| Combined Exercise Group | Aerobic Capacity Measurement V02 Max | Week 12 (post intervention) | 33.4 mililiter/kilogram/minute | Standard Deviation 3.8 |
| Aerobic Exercise Group | Aerobic Capacity Measurement V02 Max | Baseline | 29.5 mililiter/kilogram/minute | Standard Deviation 2.1 |
| Aerobic Exercise Group | Aerobic Capacity Measurement V02 Max | Week 12 (post intervention) | 32.5 mililiter/kilogram/minute | Standard Deviation 2.2 |
| Aerobic Exercise Group | Aerobic Capacity Measurement V02 Max | Week 20 (follow up) | 31.1 mililiter/kilogram/minute | Standard Deviation 2 |
| Control Group | Aerobic Capacity Measurement V02 Max | Baseline | 28 mililiter/kilogram/minute | Standard Deviation 1.6 |
| Control Group | Aerobic Capacity Measurement V02 Max | Week 20 (follow up) | 28.1 mililiter/kilogram/minute | Standard Deviation 1.9 |
| Control Group | Aerobic Capacity Measurement V02 Max | Week 12 (post intervention) | 28.1 mililiter/kilogram/minute | Standard Deviation 1.7 |
Comparison: Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over timep-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.747ANOVA
Secondary
Anxiety
Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscale . Higher points are associated with worse anxiety or depression
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Anxiety | Week 12 (post intervention) | 8.5 score on a scale | Standard Deviation 2.6 |
| Combined Exercise Group | Anxiety | Baseline | 10.3 score on a scale | Standard Deviation 3.5 |
| Combined Exercise Group | Anxiety | Week 20 (follow up) | 8.3 score on a scale | Standard Deviation 2.4 |
| Aerobic Exercise Group | Anxiety | Week 12 (post intervention) | 6 score on a scale | Standard Deviation 2.6 |
| Aerobic Exercise Group | Anxiety | Baseline | 7.8 score on a scale | Standard Deviation 3.9 |
| Aerobic Exercise Group | Anxiety | Week 20 (follow up) | 6.5 score on a scale | Standard Deviation 2.4 |
| Control Group | Anxiety | Baseline | 6.3 score on a scale | Standard Deviation 3.9 |
| Control Group | Anxiety | Week 20 (follow up) | 5.8 score on a scale | Standard Deviation 3.4 |
| Control Group | Anxiety | Week 12 (post intervention) | 6.3 score on a scale | Standard Deviation 3.3 |
Comparison: Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over timep-value: 0.018ANOVA
p-value: 0.152ANOVA
p-value: 0.438ANOVA
Secondary
Average Intensity of Headache
A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Average Intensity of Headache | Week 12(Post intervention) | 6.3 score on a scale | Standard Deviation 1.2 |
| Combined Exercise Group | Average Intensity of Headache | Baseline | 7 score on a scale | Standard Deviation 0.9 |
| Combined Exercise Group | Average Intensity of Headache | Week 20(follow up) | 6.6 score on a scale | Standard Deviation 0.9 |
| Aerobic Exercise Group | Average Intensity of Headache | Week 12(Post intervention) | 6.8 score on a scale | Standard Deviation 1 |
| Aerobic Exercise Group | Average Intensity of Headache | Baseline | 7.5 score on a scale | Standard Deviation 1.2 |
| Aerobic Exercise Group | Average Intensity of Headache | Week 20(follow up) | 6.6 score on a scale | Standard Deviation 1.1 |
| Control Group | Average Intensity of Headache | Baseline | 7.4 score on a scale | Standard Deviation 0.5 |
| Control Group | Average Intensity of Headache | Week 20(follow up) | 7.1 score on a scale | Standard Deviation 0.8 |
| Control Group | Average Intensity of Headache | Week 12(Post intervention) | 7 score on a scale | Standard Deviation 0.9 |
Comparison: Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over timep-value: 0.074ANOVA
p-value: 0.074ANOVA
p-value: 0.311ANOVA
Secondary
Change in Physical Activity Level
The International Physical Activity Questionnaires (IPAQ) short form will be used. Scoring is not classical numerical type. For activity type and duration are important for scoring. Higher points means more physical activity
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Change in Physical Activity Level | Week 12 (post intervention) | 1338.4 metabolic equivalent /week | Standard Deviation 156.3 |
| Combined Exercise Group | Change in Physical Activity Level | Baseline | 565.1 metabolic equivalent /week | Standard Deviation 328.9 |
| Combined Exercise Group | Change in Physical Activity Level | Week 20 (follow up) | 854.8 metabolic equivalent /week | Standard Deviation 301.7 |
| Aerobic Exercise Group | Change in Physical Activity Level | Week 12 (post intervention) | 1542.4 metabolic equivalent /week | Standard Deviation 379.9 |
| Aerobic Exercise Group | Change in Physical Activity Level | Baseline | 585.1 metabolic equivalent /week | Standard Deviation 427.9 |
| Aerobic Exercise Group | Change in Physical Activity Level | Week 20 (follow up) | 867 metabolic equivalent /week | Standard Deviation 438.5 |
| Control Group | Change in Physical Activity Level | Baseline | 415.1 metabolic equivalent /week | Standard Deviation 272.9 |
| Control Group | Change in Physical Activity Level | Week 20 (follow up) | 552.1 metabolic equivalent /week | Standard Deviation 359.7 |
| Control Group | Change in Physical Activity Level | Week 12 (post intervention) | 660.8 metabolic equivalent /week | Standard Deviation 514.6 |
Comparison: Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over timep-value: 0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.05ANOVA
Secondary
Depression
Hospital Anxiety and Depression Scale (HADS) will be used. Score could score between 0 and 21 for either anxiety or depression subscales . Higher points are associated with worse anxiety or depression
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Depression | Week 12 (post intervention) | 5.6 score on a scale | Standard Deviation 4.4 |
| Combined Exercise Group | Depression | Baseline | 7 score on a scale | Standard Deviation 5.8 |
| Combined Exercise Group | Depression | Week 20 (follow up) | 5.5 score on a scale | Standard Deviation 4.3 |
| Aerobic Exercise Group | Depression | Week 12 (post intervention) | 5.8 score on a scale | Standard Deviation 2.9 |
| Aerobic Exercise Group | Depression | Baseline | 6.8 score on a scale | Standard Deviation 3.1 |
| Aerobic Exercise Group | Depression | Week 20 (follow up) | 6.1 score on a scale | Standard Deviation 3.3 |
| Control Group | Depression | Baseline | 5.4 score on a scale | Standard Deviation 2.8 |
| Control Group | Depression | Week 20 (follow up) | 5.3 score on a scale | Standard Deviation 1.9 |
| Control Group | Depression | Week 12 (post intervention) | 4.9 score on a scale | Standard Deviation 2.1 |
Comparison: Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over timep-value: 0.135ANOVA
p-value: 0.203ANOVA
p-value: 0.593ANOVA
Secondary
Migraine Specific Quality of Life
Migraine Disability Assessment (MIDAS) questionnaire will be used . There is no upper or lower limit on scoring. More than 21 points show severe disability. Higher points mean more disability.MIDAS Grade/ MIDAS Score: Little or No Disability 0-5 , Mild Disability 6-10 , Moderate Disability 11-20 , Severe Disability 21+
Time frame: Baseline and Week 12 and Week 20
Population: all participants who were assigned to the arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Exercise Group | Migraine Specific Quality of Life | Week 12 (post intervention) | 32.1 score on a scale | Standard Deviation 14.8 |
| Combined Exercise Group | Migraine Specific Quality of Life | Week 20 (follow up) | 35.1 score on a scale | Standard Deviation 15.4 |
| Combined Exercise Group | Migraine Specific Quality of Life | Baseline | 49 score on a scale | Standard Deviation 17.8 |
| Aerobic Exercise Group | Migraine Specific Quality of Life | Week 20 (follow up) | 32.4 score on a scale | Standard Deviation 26.4 |
| Aerobic Exercise Group | Migraine Specific Quality of Life | Baseline | 46.8 score on a scale | Standard Deviation 37 |
| Aerobic Exercise Group | Migraine Specific Quality of Life | Week 12 (post intervention) | 30.6 score on a scale | Standard Deviation 25.2 |
| Control Group | Migraine Specific Quality of Life | Week 12 (post intervention) | 39.5 score on a scale | Standard Deviation 19.3 |
| Control Group | Migraine Specific Quality of Life | Baseline | 42.8 score on a scale | Standard Deviation 23.1 |
| Control Group | Migraine Specific Quality of Life | Week 20 (follow up) | 40 score on a scale | Standard Deviation 19.7 |
Comparison: Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over timep-value: 0.001ANOVA
p-value: 0.021ANOVA
p-value: 0.081ANOVA