Cognitive Impairment, Dyspnea, Fatigue, Muscle Pain
Conditions
Keywords
Long Covid, Tai Chi, Digital Therapeutics
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.
Interventions
DEVICEthe multi-domain Tai Chi Digital therapy Software Application
regular Tai Chi exercise, 40 Hz gamma sound stimulation and 18 BPM breath control exercise
Sponsors
Tim Shi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed