TaiChi-DTx for Treating Long Covid Symptoms

NCT05419219 | Unknown FDA Device

• 1 other identifier: TaiChi-DTx_for Long Covid
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Fatigue; Dyspnea; Cognitive Impairment; Muscle Pain

Keywords

Long Covid, Tai Chi, Digital Therapeutics

Outcome Measures

Primary Outcomes (3)

• 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.

  4 weeks

• 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.

  4 weeks

• 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).

  4-6 weeks

Secondary Outcomes (1)

• 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)

  4-6 weeks

Study Arms (2)

The Multi-domain Tai Chi Digital Therapy Group

ACTIVE COMPARATOR

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

The regular Tai Chi Exercise Group

PLACEBO COMPARATOR

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

Interventions

the multi-domain Tai Chi Digital therapy Software Application DEVICE

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

The Multi-domain Tai Chi Digital Therapy Group; The regular Tai Chi Exercise Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tim Shi: lead

Study Sites (1)

Tim Shi

Ellicott City, Maryland, 21042, United States

Location

Related Publications (4)

• 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.

  PMID: 35296042 BACKGROUND

• 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.

  PMID: 33830208 BACKGROUND

• 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.

  PMID: 34643720 BACKGROUND

• 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.

  PMID: 35320385 RESULT

MeSH Terms

Conditions

Fatigue; Dyspnea; Cognitive Dysfunction; Myalgia; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Tim Shi, MD, PhD

  GlobalMD Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: June 15, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: within 12 months
• Access Criteria: the public

Locations

US (1)