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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00008015
• Date of registration: 16/04/2015
• Prospective Registration: No
• Primary sponsor: Departement für Sport, Bewegung und GesundheitUniversität Basel
• Public title: Effect of Exercise training of different intensities on headache symptoms, physical fitness, cerebral capacity, endocrine function and pain perception in migraineurs
• Scientific title: Effect of Exercise training of different intensities on headache symptoms, physical fitness, cerebral capacity, endocrine function and pain perception in migraineurs - MIGSPO
• Date of first enrolment: 21/03/2014
• Target sample size: 38
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00008015
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Lars Donath
• Affiliation: Departement für Sport, Bewegung und GesundheitUniversität Basel

• Name: Gavin Brupbacher
• Affiliation: Departement für Sport, Bewegung und GesundheitUniversität Basel

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

G43.0

G43.1

Migraine without aura [common migraine]

G43.0
G43.1

Migraine with aura [classical migraine]

Intervention(s)

Group 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.
Group 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.
Group 3: Control group, i.e. no training intervention but other behaviour and medication as usual

Primary Outcome(s)

The number of days with headache will be measured using a headache diary during run-in, intervention and follow up.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Universität Basel Vizerektorat Forschung Petersgraben 35, Postfach

Ethics review

Status: Approved
Approval date: 13/08/2013
Contact:

Ethikkommission Nordwest- und Zentralschweiz (EKNZ) [Ethikkommission Nordwest- und Zentralschweiz]

Results

• URL: http://drks.de/search/en/trial/DRKS00008015#studyResults