Migraine HeadacheEarly Phase 1NCT03651583
Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
A Early Phase 1 study testing Kiko exercises-combines breathing and movement in people with Migraine Headache, run by Regional Clinical Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Kiko exercises-combines breathing and movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2006
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Kiko exercises-combines breathing and movement
- Keywords
- Migraine, Kiko, Qigong, Relaxation, Exercise
- Medical subject headings
- Migraine Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiko exercises-combines breathing and movementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pilot Trial | Other | Behavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group Receives: Behavioral: Kiko exercises-combines breathing and movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Migraine Frequency and Severity from Baseline
Change in Migraine Frequency and Severity from Baseline on LIkert Scale 1-4
Measured: 3 months
Secondary outcomes (4)
Change in number of headache free days
Change in number of headache free days from baseline based on Diary Data
Measured: 3 months
Change in number of migraine free days
Change in number of Migraine free days from baseline based on diary data
Measured: 3 months
Change in overall quality of life
Change in quality of life from baseline based on LIkert scale 1-2
Measured: 3 month
Subject satisfaction with Kiko training
Satisfaction measurement of training based on LIkert scale 1-5
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startJan 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Elinoff MD, Regional Clinical Research
- Investigators
- Victor Elinoff, MD, Principal investigator, Regional Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651583
- Sponsor's protocol ID
- Kiko Protocol 01
- Status last verified
- Aug 2018
- First submitted
- 5 Nov 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
- ClinicalTrials.gov ID
- NCT03651583
- Acronym / sponsor ID
- Kiko Protocol 01
- Conditions
- Migraine Headache
- Keywords
- Migraine, Kiko, Qigong, Relaxation, Exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Regional Clinical ResearchUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Trial | Other | Behavioral: Kiko exercises-combines breathing and movementBehavioral Intervention Kiko exercises-combines breathing and movement all study subjects no placebo or control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kiko exercises-combines breathing and movement | Behavioural | Pilot Trial |
Primary outcome
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
4 secondary outcomes
Change in number of headache free days
Time frame: 3 months
Change in number of migraine free days
Time frame: 3 months
Change in overall quality of life
Time frame: 3 month
Subject satisfaction with Kiko training
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Elinoff, MD principal investigator
Regional Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Kiko exercises-combines breathing and movement in people with Migraine Headache, run by Regional Clinical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Migraine Frequency and Severity from Baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.