TaiChi-DTx for Treating Long Covid Symptoms

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fatigue, Dyspnea, Cognitive Impairment, Muscle Pain

Intervention / Treatment
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* Device: the multi-domain Tai Chi Digital therapy Software Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The Multi-domain Tai Chi Digital Therapy Group<br>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<br>* regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise<br>|
| Placebo Comparator: The regular Tai Chi Exercise Group<br>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<br>* regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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) | The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) | 4-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long Covid, Tai Chi, Digital Therapeutics