Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches

NCT ID: NCT03651583

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-05-31

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.

Conditions

Migraine Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pilot Trial

Behavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group

Group Type: OTHER

Kiko exercises-combines breathing and movement

Intervention Type: BEHAVIORAL

Interventions

Kiko exercises-combines breathing and movement

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regional Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Victor Elinoff MD

Principal Investegator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Elinoff, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Clinical Research

Locations

Endwell Family Physicians

Endwell, New York, United States

Countries

United States

Other Identifiers

Kiko Protocol 01

Identifier Type: -

Identifier Source: org_study_id