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

Primary Purpose

Fatigue, Dyspnea, Cognitive Impairment

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
the multi-domain Tai Chi Digital therapy Software Application
Sponsored by
Tim Shi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Long Covid, Tai Chi, Digital Therapeutics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tim Shi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

The Multi-domain Tai Chi Digital Therapy Group

The regular Tai Chi Exercise Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)
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.
Overall respiratory relief measured by the Post-COVID-19 Functional Status (PCFS) Scale
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.
Cognitive impairment improvement measured by the well-validated neuropsychological measurement tests
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).

Secondary Outcome Measures

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)
The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)

Full Information

First Posted
May 3, 2022
Last Updated
February 13, 2023
Sponsor
Tim Shi
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1. Study Identification

Unique Protocol Identification Number
NCT05419219
Brief Title
TaiChi-DTx for Treating Long Covid Symptoms
Acronym
TaiChi-DTx
Official Title
Effectiveness of Multi-domain Tai Chi Digital Therapy for Survivors Affected by the Sequelae of Covid-19 (TaiChi-DTx and Long Covid)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tim Shi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Dyspnea, Cognitive Impairment, Muscle Pain
Keywords
Long Covid, Tai Chi, Digital Therapeutics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Multi-domain Tai Chi Digital Therapy Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The regular Tai Chi Exercise Group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
the multi-domain Tai Chi Digital therapy Software Application
Intervention Description
regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise
Primary Outcome Measure Information:
Title
Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)
Description
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.
Time Frame
4 weeks
Title
Overall respiratory relief measured by the Post-COVID-19 Functional Status (PCFS) Scale
Description
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.
Time Frame
4 weeks
Title
Cognitive impairment improvement measured by the well-validated neuropsychological measurement tests
Description
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).
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
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)
Description
The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)
Time Frame
4-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis with SARS-CoV2 infection via PCR during the past 3 to 6 months Must be Grade 2 and Grade 3 assessed by the Post-COVID-19 Functional Status (PCFS) Scale Exclusion Criteria: Admitted in the Intensive Care Unit due to SARS-COV2 infection or any other serve illness Psychiatric diseases and somatic co-morbidities COVID-19 infections or co-morbidities started or exacerbated during the same time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Shi, MD, PhD
Organizational Affiliation
GlobalMD Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tim Shi
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21042
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35296042
Citation
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.
Results Reference
background
PubMed Identifier
33830208
Citation
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.
Results Reference
background
PubMed Identifier
34643720
Citation
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.
Results Reference
background
PubMed Identifier
35320385
Citation
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.
Results Reference
result

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TaiChi-DTx for Treating Long Covid Symptoms

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