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临床试验/NCT04471831
NCT04471831Unknown不适用

Physiotherapy as a Complimentary Treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors With CoViD-19: A Clinical-Controlled Study

University of Lagos, Nigeria0 个研究点目标入组 30 人开始时间: 2020年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Exercise endurance

研究概览

简要总结

Background: Coronavirus (CoViD-19) positive stroke survivors (SSv) with comorbidities faces possibility for mortality. Study reports success of physiotherapy in CoViD-19 positive SSv with multiple comorbidities.

Methods: This clinical controlled study involve a minimum of 30 SSv and 30 age and sex-matched non-stroke individuals with multiple comorbidities with CoViD-19 status confirmed using Real-Time Quantitative-Polymerase Chain Reaction. The Cycle Threshold (CT) and nucleic acid content in the test sample (NA) will be recorded from the virology test results. Their exercise endurance, exercise capacities and quality of life will be assessed using 3-minutes' walk test and 3-meters test and Stroke Specific Quality of Life Questionnaire. Measurements will be taken at every three days intervals from admission to discharge from hospital-isolation. They will receive their normal treatments for CoViD-19 in addition to daily Physiotherapy for the SSv delivered through E-Platform. the Zoom and the WhatsApp video platforms will be used for the interactions between the physiotherapists and the participants. A pre-tested exercise protocol for stroke patients developed by the Stroke and Nervous System Disorders research group of the University of Lagos, Nigeria will be used for the E-exercises. The exercise package will be loaded into the phones of the participants at hospital admission. The Physiotherapists will lead in the exercises through video interaction will the participants watches the video programme. Their risks for respiratory complications (RC), ventilation (RV) and death (RD) will be analysed. Data will be analysed using independent t-test, Analysis of Co-Variance, and multivariate retrogression, survival analyses, Friedman Analysis of Variance and MannWithney U test (95% Confident Interval).

Anticipated Outcomes: It is anticipated that the outcome of this study will provide evidence for inclusion of Physiotherapy in the acute management of individuals tested positive for CoViD-19 most important for the stroke survivors tested positive for CoViD-19 at acute stage to reduce the odds of developing complications expedite discharge and reduce odd of death.

详细描述

Introduction Coronavirus disease 2019 (CoViD-19) is a new pathogen that is highly contagious, can spread quickly, and it is capable of causing enormous health, economic and societal impacts in any setting (WHO-China joint mission on CoViD-19). Although COVID 19 belongs to coronavirinae sub-family and coronaviridae family and different from other previous coronaviruses such as SARS-CoV and influenza Virus with its unique characteristics. Hence, building scenarios and strategies only on the basis of well-known pathogens risks failing to exploit all possible measures to slow transmission of the COVID-19 virus, reduce disease and save lives.

The COVID-19 virus is unique among human coronaviruses in its combination of high transmissibility, substantial fatal outcomes in some high-risk groups, and ability to cause huge societal and economic disruption. The current CoViD-19 pandemic arises from Severe Acute Respiratory Syndrome Voronavirus 2 (SARS CoV-2) which was first detected as pneumonia of unknown cause in Wuhan, China in December, 2019. It was declared as public health emergency of international concern in January, 2020 and global pandemic in February of the same year. Therefore, with the novel nature, and the continuously evolving understanding, of this coronavirus demands a tremendous agility in the capacity to rapidly adapt and change readiness and response planning both for containment and for treatment of the disease and its emerging sequels.

Before the advent of CoViD-19, different types of coronavirus known in human history include the alpha coronaviruses HCoV-229E and HCoV-NL63; the beta coronaviruses HCoV-OC43 and HCoV-HKU1; SARS-CoV, which causes severe acute respiratory syndrome (SARS); MERS-CoV, which causes Middle East respiratory syndrome (MERS). The definitive diagnosis of CoViD-19 is made by analysing respiratory samples (collected by aspiration of the airways or sputum induction) through laboratory tests to identify the virus involved using Real-Time Polymerase Chain Reaction (RT-PCR) techniques.

Although the American and Europe are mostly affected with Africa being the least affected, almost all the African countries have had their fair share of the pandemic both in incidence and in fatality. Although the first fatality was recorded in China, the fatality is now global. There is no gender variation in the global epidemiology of CoViD-19 but the males are experiencing higher fatality rate when controlled for age and the presence of comorbid health problem. However, in Nigeria, the mortality rate is 3.1% with male preponderance (2.2:1 male to female ratio) and affects more people between 31 years and 40 years.

Between 2 days to 14 days post-exposure, individuals with CoViD-19 can have symptoms ranging from mild to severe including but not limited to fever, cough, difficulty in breathing/shortness of breath, sore throat, muscle pain, chills, new loss of taste or smell, nausea, vomiting and diarrhea. Although the disease is fast spreading across the globe, yet there is no known standard cure for it neither is vaccine available against the new virus. However, as the disease manifest its clinical features, various case management/treatment guidelines are being developed and updated periodically by all national and international health organisations and the WHO.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The identification and selection of participants will be done by none of investigators. Allocation into group will also be done by none of the investigators. Outcome assessment will be done by none of the investigators. Participants will not be privy to another group

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Stroke survivors with COVID19
  • •Non-stroke individuals with COVID19

排除标准

  • •Stroke survivors still in inpatient hospital care

研究组 & 干预措施

Stroke survivors with COVID19

Experimental

The active intervention group

干预措施: Rehabilitation exercise protocol (Other)

Non-stroke individuals with COVID19

Placebo Comparator

Matching for age, sex and co-morbid status with the stroke survivors

干预措施: Rehabilitation exercise protocol (Other)

结局指标

主要结局

Exercise endurance

时间窗: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

The maximum length a patient can sustain an exercise procedure, It will be tested using the 3-minutes' walk test This is the distance covered within a 3-minute walk. The unit of measurement is in metres

Cycle Threshold (CT) values as recorded from the series of the qRT-PCR

时间窗: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

The CT value of a reaction is defined as the cycle number when the fluorescence of a PCR product can be detected above the background signal. The CT value is associated with the amount of PCR product in the reaction. The lower the CT value, the more PCR product that is present. It does not have unit of measurement

Nucleic acid values as calculated from the Cycle Threshold recorded from the series of the qRT-PCR

时间窗: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

This is the inverse of the Cycle Threshold. It does not have unit of measurement.

Quality of Life perception

时间窗: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

Perceived life experience by the participants in relation to the present situation. It does not have unit of measurement.

Exercise capacity

时间窗: From date of admission until the date of discharge from the isolation ward or date of death, whichever came first, assessed up to 18 months. Length of hospital stay before discharge/death will be documented

The maximum amount of physical exertion that a patient can sustain. It will be tested using the 3-metre walk test. This is the time taken to complete a 3-metre distance. The unit of measurement is in seconds

次要结局

未报告次要终点

研究者

发起方
University of Lagos, Nigeria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caleb Ademola Omuwa Gbiri

Senior Lecturer and Neurophysiotherapist

University of Lagos, Nigeria

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