An interventional study of the multi-domain Tai Chi Digital therapy Software Application in Fatigue, Dyspnea and Cognitive Impairment, sponsored by Tim Shi. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Tim Shi · Not applicable, Interventional, and Supportive care
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.
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Tim Shi is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise
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.
Time frame: 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.
Time frame: 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).
Time frame: 4-6 weeks
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)
Time frame: 4-6 weeks
Plan to share: Yes — the multi-domain Tai Chi Digital Therapy for Long Covid survivors
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Tim Shi