Clinical trial NCT03651583: Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
Official title: Pilot Study Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Migraine Headache
Keywords: Migraine
Kiko
Qigong
Relaxation
Exercise
Lead sponsor: Regional Clinical Research
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study hopes to show that after 3 months of Kiko training, Kiko naive patients with migraine will have a decrease in the frequency and severity of their migraines.

Detailed description: 3.1 Study Design

Eligible subjects in this pilot study will be taught a series of Kiko exercises. Subjects who meet inclusion and exclusion criteria at the screening visit will be given a diary in which they will document their migraine frequency and severity for one month. Once subject diaries are complete, subjects will meet for a group lesson to learn the background of Kiko and study exercises. A DVD or videotape will be issued for subjects to use during practice at home. Subjects will maintain a diary of their migraine headaches, as well as a diary of their exercise routines. Subjects will meet weekly to reinforce training and encourage training continuation. Diaries will be collected at the end of the first, second, and third months.

Eligibility criteria: Inclusion Criteria:

* Males or females, 18 to 70 years of age, with at least a 1-year history of migraine headaches
* With or without aura, (IHS criteria 1.1 and 1.2), who have experienced at least 4 migraines a month, or 2-3 migraines a month that last 2-3 days per attack in each of the 3 months prior to screening.
* The subjects must be naïve to Kiko and Qigong training.

Exclusion Criteria:

1. Subject has any cardiac condition, as determined by the investigator, that would preclude safe participation in a low level exercise program.
2. Uncontrolled hypertension at screening (sitting systolic pressure \>160 mmHg, diastolic pressure \>95 mmHg.)
3. Subject has had tension-type headaches, \>15 days/month in any of the 3 months prior to screening.
4. Subject has more than 8 migraines per month, or more than 16 days of migraine per month.
5. Subject is pregnant or expects to become pregnant during the course of the trial.
6. Subject has substance or alcohol abuse within the the last year which, in the investigator's judgement, will interfere with the study conduct, cooperation or evaluation and interpretation of the study results.
7. Subject has any concurrent medical or psychological condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in the trial.
8. Subject has participated in an investigational drug trial within the previous 4 weeks.
9. Subject uses pain medication in excess of 40 doses of over the counter medication and/or prescription pain medication per month to treat headaches of any type.
10. Subject is unable to differentiate between migraine and non-migraine headaches.

Primary outcomes:
measure: Change in Migraine Frequency and Severity from Baseline
timeFrame: 3 months
Secondary outcomes:
measure: Change in number of headache free days
timeFrame: 3 months
measure: Change in number of migraine free days
timeFrame: 3 months
measure: Change in overall quality of life
timeFrame: 3 month
measure: Subject satisfaction with Kiko training
timeFrame: 3 months
Other outcomes:
Locations:
city: Endwell
country: United States
facility: Endwell Family Physicians
state: New York
Study officials:
affiliation: Regional Clinical Research
name: Victor Elinoff, MD
role: PRINCIPAL_INVESTIGATOR
References: