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Effect of Exercise training of different intensities on headache symptoms, physical fitness, cerebral capacity, endocrine function and pain perception in migraineurs

Organizational Data

DRKS-ID:
DRKS00008015
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2015-04-16
Last update in DRKS:
2015-04-16
Registration type:
Retrospective

Acronym/abbreviation of the study

MIGSPO

URL of the study

No Entry

Brief summary in lay language

Migraine is a debilitating brain disorder with repeated attacks of head pain and sensory misperception. Preliminary aerobic exercise training studies suggested positive effects on migraine symptomatology, such as attack frequency, duration, and intensity. Moderate endurance training increases physical fitness, cerebral and cognitive function as well as pain perception. We aim at investigating the effects of different exercise-training regimes (high-intensity interval vs. moderate-intensity continuous training) on pain perception, quality of life, aerobic capacity, brain structure, endocrine, vascular and cognitive function, and migraine symptomatology in patients suffering from migraine.

Brief summary in scientific language

A three-armed randomized controlled intervention trial (RCT, including a run-in and follow-up period, 4 weeks each) is applied. Patients will be randomly assigned (minimization method; strata: age, gender, BMI, physical activity, migraine frequency, and cardio-respiratory fitness) to either a continuous aerobic training group (CAT), high intensity interval training group (HIIT) or the control group (CON). HIIT comprises 4 x 4 minute intervals at 90% of maximal heart rate (HRmax) with in-between breaks of 3 minutes at 70% of HRmax. CAT is performed continuously at 70% of HRmax for 45 minutes. Training is given twice a week for 12 weeks. Changes of migraine symptoms, quality of life, physical fitness, baseline beta-endorphin levels, pain perception, cognitive function, and exercise-induced plasticity in pain-processing cerebral areas as well as resting state brain networks will be examined prior to and after the intervention period.

Health condition or problem studied

ICD10:
G43.0 - Migraine without aura [common migraine]
ICD10:
G43.1 - Migraine with aura [classical migraine]
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
High-intensity interval training: running training 2x/week for 12 weeks, with 4x4 minute intervals at 90% maximum heart rate with 3 minutes active recovery in between intervals at 70% maximum heart rate. The high-intensity interval training and the continuous training are isocaloric.
Arm 2:
Continuous aerobic training: running training 2/week for 12 weeks for 45 minutes at 70% maximum heart rate. The high-intensity interval training and the continuous training are isocaloric.
Arm 3:
Control group, i.e. no training intervention but other behaviour and medication as usual

Endpoints

Primary outcome:
The number of days with headache will be measured using a headache diary during run-in, intervention and follow up.
Secondary outcome:
Headache intensity and number of days with migraine is measured during run-in, intervention and follow up using a diary. Headache associated disability (MIDAS questionnaire), cerebral (fMRI), endocrine (serum B-Endorphin), kognitive (Mini-Mental-State test, Trail Making Test, SWITCH Test, Tower of London Test, Regensburger Wortflüssigkeitstest, Frontal Assessment Batttery), and vascular function (retinal vessel diameter, SVA-T), cardio-respiratory fitness (spiroergometry), pain thresholds (thermode), and quality of life (WHO-QoL, BREF) are measured before and after the intervention phase.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Neurologische Poliklinik, Universitätsspital Basel Basel

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2014-03-21
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
38
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
50 Years
Additional Inclusion Criteria:
Diagnosis of migraine by an experienced neurologist according to the International Classification of Headache Disorders, second edition (ICHD-II).

Exclusion Criteria

(a) current medical preventive therapy (patients can be included if preventive medication was stopped at least 8 weeks before study entry), (b) other internal or neurological diseases, (c) regular exercise experiences (>2h of moderate to vigorous exercise per week) within the last 6 months, (d) patients with coronary heart disease, (e) chronic heart failure, (f) hypertension, (g) current use of antihypertensive medication or (h) peripheral arterial disease.

Addresses

Primary Sponsor

Departement für Sport, Bewegung und GesundheitUniversität Basel
Dr. Lars Donath
Birsstrasse 320 B
4052 Basel
Switzerland
Telephone:
+41 (0)61377 87 38
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Departement für Sport, Bewegung und GesundheitUniversität Basel
Dr. Lars Donath
Birsstrasse 320 B
4052 Basel
Switzerland
Telephone:
+ 41 (0)61 377 87 38
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Departement für Sport, Bewegung und GesundheitUniversität Basel
cand. MSc Gavin Brupbacher
Birsstrasse 320 B
4052 Basel
Switzerland
Telephone:
+41 (0)61 377 87 51
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Departement für Sport, Bewegung und GesundheitUniversität Basel
Dr. Lars Donath
Birsstrasse 320 B
4052 Basel
Switzerland
Telephone:
+ 41 (0)61 377 87 38
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Universität Basel Vizerektorat Forschung Petersgraben 35, Postfach
Petersgraben 35
4001 Basel
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission Nordwest- und Zentralschweiz (EKNZ) [Ethikkommission Nordwest- und Zentralschweiz]
Hebelstr. 53
4056 Basel
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://eknz.ch/

Vote of leading Ethics Committee

Date of ethics committee application:
2013-07-11
Ethics committee number:
194/13
Vote of the Ethics Committee:
Approved
Date of the vote:
2013-08-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry