A Pilot Feasibility Study of a Physiotherapy-based Tailored Intervention for Long COVID.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Feasibility (patient recruitment and retention rate)
研究概览
简要总结
The purpose of this study is to determine the benefits and feasibility of physiotherapy in the recovery of ongoing symptoms after COVID-19 illness. Long COVID Syndrome (Long COVID) is defined by persistent symptoms (including breathlessness, chest pain and fatigue) after COVID-19 illness that continue for more than 12 weeks and cannot be explained by another diagnosis. The goal of this project is to explore physiotherapy as treatment for patients suffering from Long COVID.
详细描述
The global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 [COVID-19] has resulted in catastrophic loss of life and significant morbidity in survivors. It is now recognized that a significant number of patients have symptoms lasting for weeks to months after initial infection, a clinical entity termed "Long COVID". For many patients, this has led to an unexpectedly long recovery and has negatively impacted health-related quality of life (QOL). Persisting breathlessness, fatigue and exercise limitation were among the most common patient-reported symptoms after COVID-19 infection, affecting approximately 50% of individuals. Given the heterogeneity in the causes of breathlessness post-COVID, there are no specific medications that can be broadly recommended to alleviate dyspnea among these patients. Breathing retraining, combined with supervised exercise, improves QOL and exercise capacity among patients with various chronic lung diseases and is an important potential strategy that could reduce dyspnea and regain physical function among those with Long COVID. The benefits of physiotherapy are recognized in hospitalized, and critically ill patients, and physiotherapy interventions have been studied among hospitalized patients with acute COVID-19 pneumonia. Physiotherapy may also play an instrumental role in the recovery of ambulatory patients with Long COVID, but few data currently exist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has English language fluency (approximately grade 8-10 reading level) and is able to provide informed consent.
- •Participant is an adult (aged ≥ 18 years).
- •Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.
- •Persistent symptoms lasting ≥12 weeks since the first positive test, including dyspnea (new or increased from baseline as measured by modified Medical Research Council (mMRC) score ≥1).
- •Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.
- •Participant owns a smart phone, tablet, or computer, and has or is willing to create an email address (for links to REDCap and Zoom).
排除标准
- •Abnormal pulmonary function testing (FEV1/FVC ratio <70, total lung capacity <80% predicted, or diffusing capacity <70% predicted).
- •Pre-existing diagnosis chronic lung disease (Interstitial lung disease, COPD, bronchiectasis, or moderate to severe asthma).
- •Pulmonary embolism.
- •Parenchymal abnormalities on chest radiograph, deemed clinically significant by the pulmonologist.
- •Acute or chronic cardiac disease by medical history (myocardial infarction, myocarditis, cardiomyopathy, arrhythmia, moderate or severe valve disease, ventricular dysfunction).
- •Syncope at rest or exertion (which could indicate clinically significant cardiac disease).
- •Pre-existing diagnosis of a post-viral fatigue syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia.
结局指标
主要结局
Feasibility (patient recruitment and retention rate)
时间窗: 120 days
Feasibility will be determined by recruitment of 12 participants within 3 months, retention of \>70% of participants and mean completion of \>70% of all supervised physiotherapy sessions.
次要结局
- Self-efficacy for symptom management(120 days)
- Six-minute walk test(120 days)
- Quality of life (QOL)(120 days)
- Self-reported functional status(120 days)
- One-minute sit-to-stand test(120 days)