A Prospective Study: Tai-chi and Post-COVID Insomnia

Not Applicable

Completed

• Conditions: COVID - 19; Insomnia

• Registration Number: NCT06776276
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-20
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-25
• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-01-11
• Last Update Submitted: 2025-01-11
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	from enrollment to the end of treatment at 2 weeks follow up timestamp	The ISI measures the frequency of various insomnia symptoms, including prolonged sleep latency, difficulty maintain sleep, early awakening, satisfaction with sleep, interference with the daily activities, if it is noticed by others and if it is causing distress. Each of the seven items is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), resulting in a total score that can range from 0 to 28.

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt