TaiChi-DTx for Treating Long Covid Symptoms

Fatigue Clinical Trial

— 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05419219
• Other study ID #: TaiChi-DTx_for Long Covid
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: GlobalMD Organization Network Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Dyspnea
• Fatigue
• Muscle Pain
• Myalgia

Intervention

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

Locations

Country	Name	City	State
United States	Tim Shi	Ellicott City	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Tim Shi

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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/s0025 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)	4-6 weeks