TaiChi-DTx for Treating Long Covid Symptoms

Not Applicable

• Conditions: Dyspnea; Cognitive Impairment; Muscle Pain; Fatigue
• Interventions: Device: the multi-domain Tai Chi Digital therapy Software Application

• Registration Number: NCT05419219
• Lead Sponsor: Tim Shi

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.

Study Timeline

• Study First Submitted: 2022-05-03
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Multi-domain Tai Chi Digital Therapy Group	the multi-domain Tai Chi Digital therapy Software Application	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.
The regular Tai Chi Exercise Group	the multi-domain Tai Chi Digital therapy Software Application	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tim Shi; 🇺🇸 Ellicott City, Maryland, United States