Temporal, Environmental, and Genetic Factors Regulating Exercise and Migraine

NCT04553445 | Completed

• 1 other identifier: 1607166
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain, of which migraine is among the most common, affects 100 million US adults and costs between $560 to $635 billion dollars annually. There is a need for effective, low-cost non-pharmacological strategies to reduce migraine load in migraineurs (based on International Headache Society classification International Classification of Headache Disorders \[ICHD\]-3; experience headache \[migraine-like or tension-type-like\] on 15+ days/month for 3+ months, and have migraine headaches \[either with aura or without aura\] on 8+ days/month). This represents an area of interest, as common migraine medications induce central nervous system side-effects including aphasia, ataxia, somnolescence, and vertigo; and 79% of suffers have an interest in trying novel treatment strategies with lower adverse effects than medications. Exercise has been shown to be a non-pharmacological intervention to reduce migraine burden. However, how environmental (i.e. - time-of-day, exposure to nature) and genetic factors (i.e. - polymorphisms in circadian and migraine associated genes) impact the laudatory effects of exercise remains unknown. There are independently established heritable components to migraine frequency (65%), circadian rhythm (70%), and aerobic power during exercise (66%). Thus, the central hypothesis is that an optimal environment can improve the exercise-induced reduction in migraine load, which is influenced by genetic heritability of migraine related gene polymorphisms.

Conditions

Migraine Disorders

Keywords

Chronotype; Green exercise

Outcome Measures

Primary Outcomes (4)

• Migraine load difference (evaluated by MIDAS) when exercising in sync with chronotype versus not in sync

  The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.

  Three months

• Migraine load difference (evaluated by HIT-6) when exercising in sync with chronotype versus not in sync

  The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in sync with chronotype, and before and after exercise is completed not in sync with chronotype. A one month wash out period will separate these months of exercise.

  Three months

• Migraine load difference (evaluated by MIDAS) when exercising in nature versus indoors

  The Migraine Disability Assessment (MIDAS) is a 5 question assessment which asks participants to recall the number of days activities were affected due to migraine: 1) days of work or school missed, 2) days where productivity at work or school was affected, 3) days not completing housework, 4) days where housework productivity was affected by more than half, 5) days missed family, social, or leisure activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.

  Three months

• Migraine load difference (evaluated by HIT-6) when exercising in nature versus indoors

  The Headache Impact Test (HIT-6) is a 6 question assessment which asks participants to rate on a Likert-type scale (Never, Rarely, Sometimes, Very Often, Always) how activities were affected due to migraine: 1) how often headache pain is severe, 2) how often headache limits usual daily activities, 3) how often you wish you could lie down due to headache, 4) how often you felt too tired due to headaches, 5) how often you felt fed up or irritated due to headache, 6) how often headache limited ability to concentrate on work or daily activities. The assessment will be completed before and after one month of exercise completed in natural environments, and before and after exercise is completed indoors. A one month wash out period will separate these months of exercise.

  Three months

Study Arms (2)

Chronotype

EXPERIMENTAL

Determination whether monthly migraine load is affected by exercise in sync with chronotype

Behavioral: Chronotype

Green exercise

EXPERIMENTAL

Determination whether monthly migraine load is affected by exercise in a natural environment

Behavioral: Green exercise

Interventions

Chronotype BEHAVIORAL

Participants screened using the Morningness/Eveningness Questionnaire. Chronotype categorized as either Definite Morning/Morning, or Evening/Definite Evening. Participant will exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) either in sync or not in sync with chronotype for one month in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in the alternate chronotype for one month.

Chronotype

Green exercise BEHAVIORAL

Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in alternate environment for one month.

Green exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be classified as a chronic migraineur: based on the International Headache Society classification ICHD-3; experience headache (migraine-like or tension-type-like) on 15+ days/month for 3+ months, and have migraine headaches (either with aura or without aura) on 8+ days/month.
• Participants also must also be classified into a discrepant chronotype: screened using the Morningness/Eveningness Questionnaire, into Definite Morning and Morning types; and Definite Evening and Evening types.

You may not qualify if:

• Not classified as a chronic migraineur.
• Not classified into a discrepant chronotype.
• Not classified as low health risk.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Chronotype

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Circadian Rhythm; Periodicity; Chronobiology Phenomena; Physiological Phenomena

Study Officials

• James W Navalta, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover design

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 17, 2020
• Study Start: November 23, 2020
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be available at https://dataverse.harvard.edu/

Locations

US (1)