Clinical trial NCT05419219: TaiChi-DTx for Treating Long Covid Symptoms
Official title: Effectiveness of Multi-domain Tai Chi Digital Therapy for Survivors Affected by the Sequelae of Covid-19 (TaiChi-DTx and Long Covid)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Dyspnea
Cognitive Impairment
Muscle Pain
Keywords: Long Covid, Tai Chi, Digital Therapeutics
Lead sponsor: GlobalMD Organization Network Corp
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)
timeFrame: 4 weeks
measure: Overall respiratory relief measured by the Post-COVID-19 Functional Status (PCFS) Scale
timeFrame: 4 weeks
measure: Cognitive impairment improvement measured by the well-validated neuropsychological measurement tests
timeFrame: 4-6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Ellicott City
country: United States
facility: Tim Shi
state: Maryland
Study officials:
affiliation: GlobalMD Organization
name: Tim Shi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.