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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Behavioral: Kiko exercises-combines breathing and movement

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Endwell, New York, United States, 13760
      • Endwell Family Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Pilot Trial; Behavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group	Behavioral: Kiko exercises-combines breathing and movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Migraine Frequency and Severity from Baseline	Change in Migraine Frequency and Severity from Baseline on LIkert Scale 1-4	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of headache free days	Change in number of headache free days from baseline based on Diary Data	3 months
Change in number of migraine free days	Change in number of Migraine free days from baseline based on diary data	3 months
Change in overall quality of life	Change in quality of life from baseline based on LIkert scale 1-2	3 month
Subject satisfaction with Kiko training	Satisfaction measurement of training based on LIkert scale 1-5	3 months

Collaborators and Investigators

• Sponsor: Regional Clinical Research
• Investigators: Principal Investigator: Victor Elinoff, MD, Regional Clinical Research

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): May 1, 2006
• Study Completion (ACTUAL): May 1, 2006

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (ACTUAL): August 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Migraine; Relaxation; Qigong; Kiko
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: Kiko Protocol 01