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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Shi, MD, PhD | GlobalMD Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tim Shi | Ellicott City | Maryland | 21042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35296042 | Background | 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. | |
| 33830208 | 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. |
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the multi-domain Tai Chi Digital Therapy for Long Covid survivors
within 12 months
the public
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D004417 | Dyspnea |
| D060825 | Cognitive Dysfunction |
| D063806 | Myalgia |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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.
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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.
| 34643720 | 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. |
| 35320385 | Result | 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. |
| D012818 | Signs and Symptoms, Respiratory |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |