NCT06776276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

January 11, 2025

Last Update Submit

January 11, 2025

Conditions

InsomniaCOVID - 19

Keywords

InsomniaCOVID-19Tai Chi exercisesInsomnia severity index

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity Index

    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.

    from enrollment to the end of treatment at 2 weeks follow up timestamp

Study Arms (2)

Post-COVID Insomnia

ACTIVE COMPARATOR
Behavioral: Tai Chi exercises

non-COVID-19-related insomnia

NO INTERVENTION

Interventions

Tai Chi exercisesBEHAVIORAL

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.

Post-COVID Insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 29765313BACKGROUND

  • 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.

    PMID: 36153623BACKGROUND

  • 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.

    PMID: 30186352BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersCOVID-19

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 15, 2025

Study Start

September 20, 2020

Primary Completion

December 30, 2023

Study Completion

January 25, 2024

Last Updated

January 15, 2025

Record last verified: 2020-09

Locations

EG(1)