Temporal, Environmental, and Genetic Factors Regulating Exercise and Migraine
NCT04553445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2022-11-28
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
Interventions
- BEHAVIORAL
-
Chronotype
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.
- BEHAVIORAL
-
Green exercise
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.
Sponsors & Collaborators
-
University of Nevada, Las Vegas
lead OTHER
Principal Investigators
-
James W Navalta, PhD · University of Nevada, Las Vegas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-11-23
- Primary Completion
- 2022-03-31
- Completion
- 2022-05-31
Countries
- United States
Study Locations
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