TaiChi-DTx for Treating Long Covid Symptoms

NCT ID: NCT05419219

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

Brief Summary

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The randomized controlled trial will be conducted to evaluate the effectiveness of a Multi-domain Tai Chi Digital Therapy for treating the individuals suffering from the long term COVID-19 syndrome (Long COVID).

Detailed Description

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The randomized controlled trial will be conducted to evaluate the effectiveness of a Multi-domain Tai Chi Digital Therapy for treating the individuals suffering from the long term COVID-19 syndrome (Long COVID).

This intervention will comprise of traditional Tai Chi physical therapy with background music entraining 40 Hz sound wave and respiratory control training. The Multi-domain Tai Chi Digital Therapy will be delivered via a tablet or smart phone to participants for a 4-week therapeutic cycle. Clinical standardized physical tests and self-scored questionnaires will be collected to understand the change in symptoms, including fatigue, dyspnea, and brain fog, as well as absenteeism.

Conditions

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Fatigue Dyspnea Cognitive Impairment Muscle Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To evaluate the effectiveness of Multi-domain Tai Chi Digital Therapy for treating the long term sequalae symptoms among COVID-19 survivors compared with traditional Tai Chi exercise only as control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The Multi-domain Tai Chi-DTx will be provided via a tablet or smart phone. The traditional Tai Chi exercise with background music and respiratory control exercise with 18 BPM metronome, and 40 Hz sound stimulation will be comprised in a 4-week therapeutic session.

A control arm will be designed in this study, which will use the same way to deliver traditional Tai Chi exercise with plain music background only.

Study Groups

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The Multi-domain Tai Chi Digital Therapy Group

participants will be provided via a tablet or smart phone the traditional Tai Chi exercise with background music and respiratory control exercise with 18 BPM metronome, and 40 Hz sound stimulation for 4-week therapeutic session.

Group Type ACTIVE_COMPARATOR

the multi-domain Tai Chi Digital therapy Software Application

Intervention Type DEVICE

regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise

The regular Tai Chi Exercise Group

participants will be provided by the same way to deliver traditional Tai Chi exercise with plain music background, but without respiratory control exercise or 40 Hz sound stimulation. All participants will receive any other routine care or treatment as usual (TAU).

Group Type PLACEBO_COMPARATOR

the multi-domain Tai Chi Digital therapy Software Application

Intervention Type DEVICE

regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise

Interventions

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the multi-domain Tai Chi Digital therapy Software Application

regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis with SARS-CoV2 infection via PCR during the past 3 to 6 months
2. Must be Grade 2 and Grade 3 assessed by the Post-COVID-19 Functional Status (PCFS) Scale

Exclusion Criteria

1. Admitted in the Intensive Care Unit due to SARS-COV2 infection or any other serve illness
2. Psychiatric diseases and somatic co-morbidities
3. COVID-19 infections or co-morbidities started or exacerbated during the same time
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tim Shi

OTHER

Sponsor Role lead

Responsible Party

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Tim Shi

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tim Shi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

GlobalMD Organization

Locations

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Tim Shi

Ellicott City, Maryland, United States

Site Status

Countries

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United States

References

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Castro JP, Kierkegaard M, Zeitelhofer M. A Call to Use the Multicomponent Exercise Tai Chi to Improve Recovery From COVID-19 and Long COVID. Front Public Health. 2022 Feb 28;10:827645. doi: 10.3389/fpubh.2022.827645. eCollection 2022.

Reference Type BACKGROUND
PMID: 35296042 (View on PubMed)

Gaber TAK, Ashish A, Unsworth A. Persistent post-covid symptoms in healthcare workers. Occup Med (Lond). 2021 Jun 16;71(3):144-146. doi: 10.1093/occmed/kqab043.

Reference Type BACKGROUND
PMID: 33830208 (View on PubMed)

Groff D, Sun A, Ssentongo AE, Ba DM, Parsons N, Poudel GR, Lekoubou A, Oh JS, Ericson JE, Ssentongo P, Chinchilli VM. Short-term and Long-term Rates of Postacute Sequelae of SARS-CoV-2 Infection: A Systematic Review. JAMA Netw Open. 2021 Oct 1;4(10):e2128568. doi: 10.1001/jamanetworkopen.2021.28568.

Reference Type BACKGROUND
PMID: 34643720 (View on PubMed)

Verger A, Kas A, Dudouet P, Goehringer F, Salmon-Ceron D, Guedj E. Visual interpretation of brain hypometabolism related to neurological long COVID: a French multicentric experience. Eur J Nucl Med Mol Imaging. 2022 Jul;49(9):3197-3202. doi: 10.1007/s00259-022-05753-5. Epub 2022 Mar 23.

Reference Type RESULT
PMID: 35320385 (View on PubMed)

Other Identifiers

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TaiChi-DTx_for Long Covid

Identifier Type: -

Identifier Source: org_study_id

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