TaiChi-DTx for Treating Long Covid Symptoms (TaiChi-DTx)

February 13, 2023 updated by: Tim Shi

Effectiveness of Multi-domain Tai Chi Digital Therapy for Survivors Affected by the Sequelae of Covid-19 (TaiChi-DTx and Long Covid)

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Ellicott City, Maryland, United States, 21042
        • Tim Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: the multi-domain Tai Chi Digital therapy Software Application
regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise
Placebo Comparator: 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).
Device: the multi-domain Tai Chi Digital therapy Software Application
regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)
Time Frame: 4 weeks
The 6-min walk test (6 MWT), a recognized norm by American Thoracic Society, is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-min walk distance (6 MWD) in a 30 meter or 100 foot walkway provides a measure for the integrated response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
4 weeks
Overall respiratory relief measured by the Post-COVID-19 Functional Status (PCFS) Scale
Time Frame: 4 weeks
The PCFS scale covers the entire range of functional limitations, including changes in lifestyle, sports, and social activities, and has been widely used as a standard tool to assess recovery after COVID-19 infections (Garout, M.A, 2022). The assignment of a PCFS scale grade concerns the average situation of the past week. The symptoms included in PCFS are dyspnea, pain, fatigue, muscle weakness, memory loss, depression, and anxiety.
4 weeks
Cognitive impairment improvement measured by the well-validated neuropsychological measurement tests
Time Frame: 4-6 weeks
Assessment tools including Number Span forward (attention) and backward (working memory) (Becker et al. 2021), and Trail Making Test (processing speed and executive functioning), etc (Douaud, G, et al. 2022).
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of hours/days absent from work related to Long COVID symptoms survey by web-based questionnaires (time frame 6 months after SARS-CoV-2 infection)
Time Frame: 4-6 weeks
The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tim Shi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaiChi-DTx_for Long Covid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the multi-domain Tai Chi Digital Therapy for Long Covid survivors

IPD Sharing Time Frame

within 12 months

IPD Sharing Access Criteria

the public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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