Primary objective is firstly to test the feasibility and the desirability of an intervention including coaching sessions and a pedometer both to improve the level of physical activity of patients with migraine, secondly to explore the difference in…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the feasibility and desirability of the
intervention (experience of the patients with migraine, the neurologists and
the coach with the intervention; drop-out rates, costs of the coaching) and
secondary effects on the level of physical activity, the migraine status, and
the healthcare costs).
Secondary outcome
Migraine status (frequency, duration & intensity of the migraine attacks,
Headache Impact Test (HIT-6, Yang et al. 2011)), level of physical activity
(Activ8, (Horemans et al) & SQUASH (Wendel * Vos et al. 2003)),self-perceived
fitness (International FItness Scale (IFIS, Ortega et al. 2011), self-efficacy
(HMSE, French et al. 2000; Merelle et al. 2008) and quality of life (SF-36,
Aaronson et al 1998).
Background summary
Migraine is a huge health problem, with a high prevalence worldwide and high
socio-economic and personal impacts. There might be positive effects of being
more physical active (PA) on migraine, but the evidence to support this
statement is limited and the mechanism for this effect is unknown. Our
hypothesis is that PA coaching plus objective PA feedback has a positive effect
on the level of physical activity and that physical activity has a positive
effect on the migraine status.
Study objective
Primary objective is firstly to test the feasibility and the desirability of an
intervention including coaching sessions and a pedometer both to improve the
level of physical activity of patients with migraine, secondly to explore the
difference in migraine attack reduction between the experimental and control
group, in order to calculate the sample size for the main study.
Secondary objective is to compare the effect of the intervention between the
experimental group and the control group (who will receive care as usual).
Study design
Pilot randomized intervention study
Intervention
The participants will be 1:1 randomized to the experimental and control group.
Patients in the experimental group (15) will have 1 face-to-face introductory
meeting (45-60 minutes) and 9 telephone conversations (30-45 minutes) with a
coach during 6 months. Furthermore, patients will make use of a pedometer.
Patients in the control group will receive care as usual (medication and once
the advice of a physical therapist to become more physical active).
Study burden and risks
The introductory meeting will be scheduled before or after a consult with the
neurologist; the other coaching sessions will be carried out by phone. Patients
will be asked to wear an accelerometer for one week twice (just before and
right after the intervention) and they will be wearing a pedometer during the
intervention. Furthermore, they will receive coaching and they will be asked to
fill out a short questionnaire on their migraine status, level of physical
activity and their quality of life.
There are no risks associated with participating in this study.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed by a neurologist based on the International Classification of Headache
Disorders-II-criteria
- Age between 18 and 65
- Frequency of 2-8 attacks per month
- Unsuccessfully tried at least 2 prophylactic medications for migraine
- Being ready for change (measured with the University of Rhode Island Change Assessment, URICA-E2) (Lerdal et al. 2009)
Exclusion criteria
- Unable to speak, read or write Dutch
- Being pregnant
- A serious psychological or psychiatric disorder
- Taking part in top-class sport
- Migraine attacks 15 or more days a month
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57995.078.16 |