Trial Outcomes & Findings for The Effect of Different Exercise Types on Migraine Frequency in Individuals With Migraine (NCT NCT05568004)
NCT ID: NCT05568004
Last Updated: 2025-03-10
Results Overview
Defined as the number of days with a migraine headache in a month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and Week 12 and Week 20
Results posted on
2025-03-10
Participant Flow
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.
Of 32 enrolled participants , 24 participants filled out baseline headache diaries regularly and were randomized to groups
Participant milestones
| Measure |
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.
|
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
|
Control Group
no intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 13 • n=8 Participants
|
36 years
STANDARD_DEVIATION 11 • n=8 Participants
|
44 years
STANDARD_DEVIATION 5 • n=8 Participants
|
39.8 years
STANDARD_DEVIATION 10.3 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body weight
|
74 kilogram
STANDARD_DEVIATION 14 • n=8 Participants
|
68 kilogram
STANDARD_DEVIATION 10 • n=8 Participants
|
75 kilogram
STANDARD_DEVIATION 12 • n=8 Participants
|
71.9 kilogram
STANDARD_DEVIATION 12.12 • n=24 Participants
|
|
Height
|
166 centimeter
STANDARD_DEVIATION 10 • n=8 Participants
|
163 centimeter
STANDARD_DEVIATION 5 • n=8 Participants
|
162 centimeter
STANDARD_DEVIATION 2 • n=8 Participants
|
163.5 centimeter
STANDARD_DEVIATION 6.35 • n=24 Participants
|
|
Body mass index
|
26.60 kilogram/square meter
STANDARD_DEVIATION 3.46 • n=8 Participants
|
25.50 kilogram/square meter
STANDARD_DEVIATION 3.84 • n=8 Participants
|
28.45 kilogram/square meter
STANDARD_DEVIATION 5.15 • n=8 Participants
|
26.85 kilogram/square meter
STANDARD_DEVIATION 4.21 • n=24 Participants
|
|
Migraine duration
|
13.2 years
STANDARD_DEVIATION 12.9 • n=8 Participants
|
8.5 years
STANDARD_DEVIATION 10 • n=8 Participants
|
16.8 years
STANDARD_DEVIATION 7.8 • n=8 Participants
|
12.8 years
STANDARD_DEVIATION 10.5 • n=24 Participants
|
|
Number of Participants with Migraine Aura
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Preventive drugs number
|
1 mean number of medication used
STANDARD_DEVIATION 1 • n=8 Participants
|
1 mean number of medication used
STANDARD_DEVIATION 1 • n=8 Participants
|
1 mean number of medication used
STANDARD_DEVIATION 0 • n=8 Participants
|
1 mean number of medication used
STANDARD_DEVIATION 0.48 • n=24 Participants
|
|
Beta blocker use
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
|
Serotonin and norepinephrine reuptake inhibitors (SNRIs) use
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Tricyclic antidepressants (TCAs)
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Number of participants using medication for migraine attack treatment(triptan)
|
5 participants
n=8 Participants
|
7 participants
n=8 Participants
|
7 participants
n=8 Participants
|
19 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
Defined as the number of days with a migraine headache in a month
Outcome measures
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
|---|---|---|---|
|
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
|
8.8 days/month
Standard Deviation 4.1
|
10.6 days/month
Standard Deviation 3.2
|
|
Change in the Number of Days With Migraine (in Migraine Frequency)
Baseline
|
9.9 days/month
Standard Deviation 4.2
|
12.4 days/month
Standard Deviation 4.5
|
11.8 days/month
Standard Deviation 3.4
|
|
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
|
8 days/month
Standard Deviation 4.5
|
10.6 days/month
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
A categorical, 11 points visual analogue scale will be used to rate each headache between 0-10. Higher scores mean higher severity headache
Outcome measures
| Measure |
Combined Exercise Group
n=43 headaches
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.
|
Aerobic Exercise Group
n=47 headaches
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
|
Control Group
n=44 headaches
no intervention
|
|---|---|---|---|
|
Average Intensity of Headache
Baseline
|
7 score on a scale
Standard Deviation 0.9
|
7.5 score on a scale
Standard Deviation 1.2
|
7.4 score on a scale
Standard Deviation 0.5
|
|
Average Intensity of Headache
Week 12(Post intervention)
|
6.3 score on a scale
Standard Deviation 1.2
|
6.8 score on a scale
Standard Deviation 1
|
7 score on a scale
Standard Deviation 0.9
|
|
Average Intensity of Headache
Week 20(follow up)
|
6.6 score on a scale
Standard Deviation 0.9
|
6.6 score on a scale
Standard Deviation 1.1
|
7.1 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
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
Outcome measures
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
|---|---|---|---|
|
Anxiety
Week 12 (post intervention)
|
8.5 score on a scale
Standard Deviation 2.6
|
6 score on a scale
Standard Deviation 2.6
|
6.3 score on a scale
Standard Deviation 3.3
|
|
Anxiety
Week 20 (follow up)
|
8.3 score on a scale
Standard Deviation 2.4
|
6.5 score on a scale
Standard Deviation 2.4
|
5.8 score on a scale
Standard Deviation 3.4
|
|
Anxiety
Baseline
|
10.3 score on a scale
Standard Deviation 3.5
|
7.8 score on a scale
Standard Deviation 3.9
|
6.3 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
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
Outcome measures
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
|---|---|---|---|
|
Depression
Baseline
|
7 score on a scale
Standard Deviation 5.8
|
6.8 score on a scale
Standard Deviation 3.1
|
5.4 score on a scale
Standard Deviation 2.8
|
|
Depression
Week 12 (post intervention)
|
5.6 score on a scale
Standard Deviation 4.4
|
5.8 score on a scale
Standard Deviation 2.9
|
4.9 score on a scale
Standard Deviation 2.1
|
|
Depression
Week 20 (follow up)
|
5.5 score on a scale
Standard Deviation 4.3
|
6.1 score on a scale
Standard Deviation 3.3
|
5.3 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
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+
Outcome measures
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
|---|---|---|---|
|
Migraine Specific Quality of Life
Baseline
|
49 score on a scale
Standard Deviation 17.8
|
46.8 score on a scale
Standard Deviation 37
|
42.8 score on a scale
Standard Deviation 23.1
|
|
Migraine Specific Quality of Life
Week 12 (post intervention)
|
32.1 score on a scale
Standard Deviation 14.8
|
30.6 score on a scale
Standard Deviation 25.2
|
39.5 score on a scale
Standard Deviation 19.3
|
|
Migraine Specific Quality of Life
Week 20 (follow up)
|
35.1 score on a scale
Standard Deviation 15.4
|
32.4 score on a scale
Standard Deviation 26.4
|
40 score on a scale
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
Astrand submaximal bicycle ergometer test will be used to measure aerobic capacity.
Outcome measures
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
|---|---|---|---|
|
Aerobic Capacity Measurement V02 Max
Baseline
|
30.1 mililiter/kilogram/minute
Standard Deviation 3
|
29.5 mililiter/kilogram/minute
Standard Deviation 2.1
|
28 mililiter/kilogram/minute
Standard Deviation 1.6
|
|
Aerobic Capacity Measurement V02 Max
Week 12 (post intervention)
|
33.4 mililiter/kilogram/minute
Standard Deviation 3.8
|
32.5 mililiter/kilogram/minute
Standard Deviation 2.2
|
28.1 mililiter/kilogram/minute
Standard Deviation 1.7
|
|
Aerobic Capacity Measurement V02 Max
Week 20 (follow up)
|
32.1 mililiter/kilogram/minute
Standard Deviation 3.6
|
31.1 mililiter/kilogram/minute
Standard Deviation 2
|
28.1 mililiter/kilogram/minute
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: all participants who were assigned to the arm
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
Outcome measures
| Measure |
Combined Exercise Group
n=8 Participants
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.
|
Aerobic Exercise Group
n=8 Participants
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
|
Control Group
n=8 Participants
no intervention
|
|---|---|---|---|
|
Change in Physical Activity Level
Baseline
|
565.1 metabolic equivalent /week
Standard Deviation 328.9
|
585.1 metabolic equivalent /week
Standard Deviation 427.9
|
415.1 metabolic equivalent /week
Standard Deviation 272.9
|
|
Change in Physical Activity Level
Week 12 (post intervention)
|
1338.4 metabolic equivalent /week
Standard Deviation 156.3
|
1542.4 metabolic equivalent /week
Standard Deviation 379.9
|
660.8 metabolic equivalent /week
Standard Deviation 514.6
|
|
Change in Physical Activity Level
Week 20 (follow up)
|
854.8 metabolic equivalent /week
Standard Deviation 301.7
|
867 metabolic equivalent /week
Standard Deviation 438.5
|
552.1 metabolic equivalent /week
Standard Deviation 359.7
|
Adverse Events
Combined Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aerobic Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yunus Emre Meydanal
Ege University Faculty of Medicine Sport Medicine Department
Phone: 905068046512
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place