Effectiveness of Multi-domain Tai Chi Digital Therapy for Survivors Affected by the Sequelae of Covid-19 (TaiChi-DTx and Long Covid)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
The Multi-domain Tai Chi Digital Therapy Group
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.
干预措施: the multi-domain Tai Chi Digital therapy Software Application (Device)
The regular Tai Chi Exercise Group
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).
干预措施: the multi-domain Tai Chi Digital therapy Software Application (Device)
结局指标
主要结局
Change in Physical Activity ability measured by 6-minute walking distance measurement (6MWT)
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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)
研究者
Tim Shi
Director
GlobalMD Organization Network Corp