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OpenTrials
Completed

NCT Number: NCT06776276

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi exercises

Behavioral

Tai-chi (TC) is a kind of CAM Qigong exercises, is a type of classic Chinese martial arts. It entails deliberate, slow-motion physical movements that are done alongside inward concentration, awareness of breathing, and the inherent power or energy in the body. It promotes general purposes of health and spirituality. It is generally accessible and offered to older people in public places.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

The Impact of Adding Tai-chi Training to Pharmacotherapy in Post Covid Insomnia: a Prospective Study.

Acronym: insomnia

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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