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

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ClinicalTrials.gov Identifier: NCT03651583
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Victor Elinoff MD, Regional Clinical Research

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.

Condition or disease Intervention/treatment Phase
Migraine Headache Behavioral: Kiko exercises-combines breathing and movement Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
Study Start Date : January 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in Migraine Frequency and Severity from Baseline [ Time Frame: 3 months ]
    Change in Migraine Frequency and Severity from Baseline on LIkert Scale 1-4


Secondary Outcome Measures :
  1. Change in number of headache free days [ Time Frame: 3 months ]
    Change in number of headache free days from baseline based on Diary Data

  2. Change in number of migraine free days [ Time Frame: 3 months ]
    Change in number of Migraine free days from baseline based on diary data

  3. Change in overall quality of life [ Time Frame: 3 month ]
    Change in quality of life from baseline based on LIkert scale 1-2

  4. Subject satisfaction with Kiko training [ Time Frame: 3 months ]
    Satisfaction measurement of training based on LIkert scale 1-5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651583


Locations
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United States, New York
Endwell Family Physicians
Endwell, New York, United States, 13760
Sponsors and Collaborators
Regional Clinical Research
Investigators
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Principal Investigator: Victor Elinoff, MD Regional Clinical Research

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Responsible Party: Victor Elinoff MD, Principal Investegator, Regional Clinical Research
ClinicalTrials.gov Identifier: NCT03651583     History of Changes
Other Study ID Numbers: Kiko Protocol 01
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Victor Elinoff MD, Regional Clinical Research:
Migraine
Kiko
Qigong
Relaxation
Exercise

Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms