NCT03015753

The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women

A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility, acceptability, compliance and maintenance of Tai Chi exercise among this population.

Detailed description

Migraine is a disabling neurological condition, characterized by attacks of headache and associated symptoms such as photophobia, nausea, and vomiting. In Hong Kong, the overall prevalence is around 12.5%. People with repeated migraine attacks are pain and personal suffering, have impaired social and personal life, and increased financial cost of medication. More nonpharmacologic prophylactic treatments are needed to reduce the high disease burden. As a body-mind exercise, Tai Chi's potential therapeutic efficacy on the prophylaxis of migraine has caught our attention. The investigators propose to conduct a two-arm individual level randomized controlled trial. Local women diagnosed with episodic migraine between 18-65 years will be randomly assigned to one of two groups: 1) a Tai Chi training ("TC"); or 2) a waiting list control group ("control"). The control group will receive a "delayed" Tai Chi training at the end of the trial. A total of 60 participants will be randomized and the intervention period will be 12 weeks with another 12-week follow-up. Number of attacks per month (frequency of attack), intensity and duration of headache, stress, sleep quality and quantity, fatigue, HRQoL, and body composition will be measured at baseline and at 12 weeks and 24 weeks. The primary outcomes are the difference in frequency of attack from baseline to the 12 weeks after randomization, and the proportion of patients with at least a 50% reduction of the number of attacks per month. The intervention effect will be estimated by calculating the differences of outcomes from baseline to the end of the trial between the intervention and control groups using intention-to-treat analysis.

Conditions

• Migraine Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Tai Chi training	The 12-week Tai Chi training will be prescribed with three 1-hour instructor-led sessions and two 1-hour self-practice sessions per week. A modified 32-short form Yang-style Tai Chi Chuan will be adopted. The instructor-led sessions will be operated by qualified Tai Chi masters. The training activity will be delivered in group. The group size is 15 to 18 persons.
OTHER	Waiting list control group	At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2017-01-10
• Last updated: 2022-05-19

Locations

1 site across 1 country: Hong Kong