Self- Applied Acupressure and Online Qigong for Patients Suffering From Chronic Fatigue After Corona Virus Infection 19 (COVID-19) - a Randomized Controlled Mixed-methods Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- SF-36 Physical Function subscale
研究概览
简要总结
International observational studies confirm the high incidence of post-infectious residual syndrome after infection with severe acute respiratory syndrome corona virus 2 (SARS-COV2), which can occur in 10-15% of all infected persons, regardless of the severity of the acute infection. Post corona virus disease 19 (postCOVID-19) patients suffer mostly from symptoms such as fatigue, muscle pain, problems to focus, depression and sleep disturbances.
So far, there are no results of interventional studies for the treatment of chronic fatigue post COVID-19, but there are indicators that post COVID-19 syndrome is a chronic subclinical inflammation, similar to Chronic Fatigue Syndrome / Myalgic Encephalomyelitis CSF/ME, which also often develops from a postviral syndrome. Previously tested and effective strategies for the treatment of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME) will be tested in the treatment of chronic fatigue postCOVID-19, in this randomized controlled trial a combination of acupressure and Qigong.
The aim of this project is to evaluate an acupressure treatment plus a Qigong exercise series specifically tailored for chronic fatigue postCOVID-19 , used daily by the patients themselves and regularly supervised, in comparison to the advice literature on the treatment of PostCOVID-19 syndrome alone.
详细描述
Prospective two-arm (parallel groups) randomised controlled confirmatory intervention study with mixed methods approach in 2x 100 patients (n=200).
Intervention: self-applied acupressure and online Qigong course over 8 weeks and follow up at week 16.
Group 1: Acupressure + Qigong: Massage of the points daily for 3 minutes per point with the finger or an acupuncture pen (some points can be massaged bilaterally, therefore total approx. 20 min). In addition, twice a week an online guided Qigong course with a duration of 30-45 min. The patients should practise Qigong at least 3 times a week (including the course date). In addition, all patients will receive the guidebook literature for the treatment of complaints after SARS-CoV2 infection.
Group 2: Patients will receive advice literature on the treatment of chronic fatigue after SARS-CoV2 infection. After the end of this study the patients of this group will receive written information and video material regarding the acupressure and Qigong exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of chronic fatigue (after SARS-CoV2 infection)
- •with at least 3 of 7 criteria at time of study inclusion: sleeping disorder, headaches, joint pain/muscle pain, anxiety/depression, memory impairment/ concentration problems, anosmia, exercise intolerance.
- •acute SARS-CoV2 infection at least 12 weeks ago
- •age 18-60 years
- •visual analogue scale (0-100 mm) physical resilience of maximum 60 mm
- •SF-36 physical function of maximum 65
- •technically equipped to participate in the online intervention and willing to follow the study procedure, acupressure and Qigong to perform the exercise series at home
- •written informed consent available.
排除标准
- •fatigue already present before the SARS-CoV2 infection
- •other underlying diseases leading to symptoms of chronic fatigue, such as major depression, oncological diseases, multiple sclerosis, fibromyalgia and drug abuse
- •other serious underlying diseases, such as severe pulmonary, cardiac, psychiatric or infectious diseases, which could interfere with study participation or affect the results
- •ongoing opioid therapy or opioid therapy in the week prior to study entry
- •chronic use of cannabinoids before or during the study.
- •start of psychotherapy or interruption of ongoing therapy during study participation
- •female participants: pregnancy or breastfeeding
- •participation in another clinical intervention study during study participation
- •ongoing pension procedure or planned claiming of a pension procedure due to disability
- •planned inpatient rehabilitation measures during study participation due to PostCOVID-19 -
结局指标
主要结局
SF-36 Physical Function subscale
时间窗: week 8
Primary study objective is to assess the changes in the mean score of the SF-36 Physical Function subscale between the two study arms assessing the degree of fatigue.
次要结局
- VAS physical resilience (visual analogue scale)(week 8 and 16)
- Spirometry(week 8 and 16)
- SF36 PFS (Short Form 36 physical function subscale)(week 16)
- PHQ9 (Patient Health Questionnaire 9)(week 8 and 16)
- autonomic dysfunction orthostasis test(week 8 and 16)
- qualitative substudy(week 8 and 16)
- EQ5D (EuroQoL 5 domains)(week 8 and 16)
- Chalder Fatigue-Scale(week 8 and 16)
- VAS pain (visual analogue scale)(week 8 and 16)
- d2- test(week 8 and 16)
- hand grip strength(week 8 and 16)
研究者
Benno Brinkhaus
Principal Investigator
Charite University, Berlin, Germany