Clinical trial NCT06776276: A Prospective Study: Tai-chi and Post-COVID Insomnia
Official title: The Impact of Adding Tai-chi Training to Pharmacotherapy in Post Covid Insomnia: a Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
COVID - 19
Keywords: Insomnia
COVID-19
Tai Chi exercises
Insomnia severity index
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to see if Tai-Chi exercises (a type of Chinese martial arts) can help people suffering from insomnia after COVID-19 when added with cognitive-behavioral therapy (CBT) and drugs compared to CBT and drugs alone. All participants will receive education on sleep hygiene practices, and the principles of cognitive behavioral therapy (CBT). If these approaches were insufficient, they will be given sleep aids, primarily Z-drugs.

All study subjects engaged in a simple Tai Chi training program for two weeks. The Tai Chi training consisted of a series of gentle physical exercises that incorporated elements of meditation, body awareness, imagery, and abdominal breathing.

A professional instructor conducted two training sessions for both patients and controls, ensuring that participants could perform the exercises independently at home during the last hour before sleep. Each session lasted twenty minutes, to be done daily. Participants were given a checklist documenting their sleep and exercise diary to confirm adherence for at least five days each week. After the two-week period, all participants are reassessed using the Insomnia severity index.


Eligibility criteria: Inclusion Criteria:

* COVID-19 infections confirmed by PCR (polymerase chain reaction)
* Over the age of 18 years

Exclusion Criteria:

* Below the age of 18 years
* Severely ill patients
* Patients with chronic respiratory complications
* Individuals with pre-existing and ongoing depression or anxiety

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: from enrollment to the end of treatment at 2 weeks follow up timestamp
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University
Study officials:
References:
citation: Osypiuk K, Thompson E, Wayne PM. Can Tai Chi and Qigong Postures Shape Our Mood? Toward an Embodied Cognition Framework for Mind-Body Research. Front Hum Neurosci. 2018 May 1;12:174. doi: 10.3389/fnhum.2018.00174. eCollection 2018.
citation: Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4.
citation: Tong Y, Chai L, Lei S, Liu M, Yang L. Effects of Tai Chi on Self-Efficacy: A Systematic Review. Evid Based Complement Alternat Med. 2018 Aug 15;2018:1701372. doi: 10.1155/2018/1701372. eCollection 2018.