Changes in Functional Exercise Capacity After PUlmonary REhabilitation in Primary Care: a Randomized, Controlled, Multicenter, Pragmatic Trial in 134 Patients With Long COVID (PuRe-COVID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Exercise capacity
研究概览
简要总结
In the PuRe COVID study (a randomized, controlled, multicenter, pragmatic trial) the investigators aim to assess the effect of a pulmonary rehabilitation program in primary care on exercise capacity (6MWT) and daily life physical activity in patients with long COVID.
134 patients with long COVID, defined by self-reported persistent COVID related symptoms ≥6 weeks after COVID-19 infection and a positive symptom score (CAT score ≥10 or mMRC score ≥2 or CIS-fatigue ≥36 or PCFS score of ≥2), will be recruited and divided into an intervention group or a control group. The intervention group will get twelve weeks of primary care pulmonary rehabilitation (PR) including coaching by primary care physiotherapists. The control group consists of usual care, which does not include a pulmonary rehabilitation program.
This study will help determine whether the type of symptoms or affected body system can impact recovery form long covid during rehabilitation and after follow-up. The investigators will analyze determinants and risk factors that characterize non-responders and non-adherers to better understand which patients with long COVID benefit from rehabilitation.
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)
盲法说明
The assessor of the 6MWT (the primary outcome) is blinded. Also the assessor of the lung function, MIP/MEP and hand grip strength is blinded.
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
- •Adult patients with status post COVID-19 (positive COVID-19 PCR or an official pharmacy performed antigen test or a self-performed test confirmed by a physician during the acute COVID-19 ≥ 6 weeks ago or positive antibodies before vaccination or positive antibodies before vaccination).
- •Persistent COVID related symptoms that were not present pre-COVID-19 or were less severe pre-COVID.
- •Symptomatic: quantified by dyspnea on exertion, loss of energy, fatigue or sleep impairment based upon the score of four questionnaires:
- •COPD Assessment Test (CAT) ≥10, and/or
- •modified Medical Research Council dyspnea scale (mMRC) ≥2, and/or
- •CIS-fatigue ≥36, and/or
- •post-COVID-19 Functional Status (PCFS) ≥2.
排除标准
- •Patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation.
- •Prior physiotherapy for long COVID if:
- •patients who have completed ≥9 sessions of physiotherapy in total for long COVID.
- •patients who completed any physiotherapy session in the previous 12 weeks for long COVID (primary care or hospital based; pulmonary or non-pulmonary).
- •Patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study.
- •Patients that are not able to give informed consent or not able to complete questionnaires.
- •Patients who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list.
- •Patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.
结局指标
主要结局
Exercise capacity
时间窗: Baseline - 12 weeks
Change in functional exercise capacity measured by 6-minute walk test (6MWT).
次要结局
- Change in quality of life(Baseline - 12 weeks - 24 weeks - 36 weeks)
- Change in physical activity(Baseline - 12 weeks)
- Change in COVID-19 related symptoms(Baseline - 12 weeks - 24 weeks - 36 weeks)
- Change in dyspnoea(Baseline - 24 weeks - 36 weeks)
- Change in functional status(Baseline - 12 weeks - 24 weeks - 36 weeks)
- Change in exercise capacity(Baseline - 24 weeks)
- Predictors of response in 6- minute walk distance (6MWD)(Post pulmonary rehabilitation)
- Change in fatigue(Baseline - 12 weeks - 24 weeks - 36 weeks)
- Change in work productivity and activity impairment.(Baseline - 24 weeks - 36 weeks)
- Change in anxiety and depression symptoms.(Baseline - 24 weeks - 36 weeks)
- Change in dysfunctional breathing(Baseline - 24 weeks - 36 weeks)