Back to resultsExamining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
Primary Purpose
Migraine Headache
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Kiko exercises-combines breathing and movement
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Headache focused on measuring Migraine, Kiko, Qigong, Relaxation, Exercise
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:
- Subject has any cardiac condition, as determined by the investigator, that would preclude safe participation in a low level exercise program.
- Uncontrolled hypertension at screening (sitting systolic pressure >160 mmHg, diastolic pressure >95 mmHg.)
- Subject has had tension-type headaches, >15 days/month in any of the 3 months prior to screening.
- Subject has more than 8 migraines per month, or more than 16 days of migraine per month.
- Subject is pregnant or expects to become pregnant during the course of the trial.
- 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.
- 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.
- Subject has participated in an investigational drug trial within the previous 4 weeks.
- 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.
- Subject is unable to differentiate between migraine and non-migraine headaches.
Sites / Locations
- Endwell Family Physicians
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pilot Trial
Arm Description
Behavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group
Outcomes
Primary Outcome Measures
Change in Migraine Frequency and Severity from Baseline
Change in Migraine Frequency and Severity from Baseline on LIkert Scale 1-4
Secondary Outcome Measures
Change in number of headache free days
Change in number of headache free days from baseline based on Diary Data
Change in number of migraine free days
Change in number of Migraine free days from baseline based on diary data
Change in overall quality of life
Change in quality of life from baseline based on LIkert scale 1-2
Subject satisfaction with Kiko training
Satisfaction measurement of training based on LIkert scale 1-5
Full Information
NCT ID
NCT03651583
First Posted
November 5, 2014
Last Updated
August 27, 2018
Sponsor
Regional Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT03651583
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Migraine, Kiko, Qigong, Relaxation, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot Trial
Arm Type
Other
Arm Description
Behavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group
Intervention Type
Behavioral
Intervention Name(s)
Kiko exercises-combines breathing and movement
Primary Outcome Measure Information:
Title
Change in Migraine Frequency and Severity from Baseline
Description
Change in Migraine Frequency and Severity from Baseline on LIkert Scale 1-4
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in number of headache free days
Description
Change in number of headache free days from baseline based on Diary Data
Time Frame
3 months
Title
Change in number of migraine free days
Description
Change in number of Migraine free days from baseline based on diary data
Time Frame
3 months
Title
Change in overall quality of life
Description
Change in quality of life from baseline based on LIkert scale 1-2
Time Frame
3 month
Title
Subject satisfaction with Kiko training
Description
Satisfaction measurement of training based on LIkert scale 1-5
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Subject has any cardiac condition, as determined by the investigator, that would preclude safe participation in a low level exercise program.
Uncontrolled hypertension at screening (sitting systolic pressure >160 mmHg, diastolic pressure >95 mmHg.)
Subject has had tension-type headaches, >15 days/month in any of the 3 months prior to screening.
Subject has more than 8 migraines per month, or more than 16 days of migraine per month.
Subject is pregnant or expects to become pregnant during the course of the trial.
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.
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.
Subject has participated in an investigational drug trial within the previous 4 weeks.
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.
Subject is unable to differentiate between migraine and non-migraine headaches.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Elinoff, MD
Organizational Affiliation
Regional Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endwell Family Physicians
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
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