Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 8
- 主要终点
- Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12
研究概览
简要总结
Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients:
- Differentiation of rehabilitation effects from natural recovery after COVID-19.
- Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID
- Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.
Therefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID 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 statistician will be 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
- •Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)
排除标准
- •no walking ability
- •not able to operate smartphone apps
- •rehabilitation program within the previous 6 months
结局指标
主要结局
Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12
时间窗: baseline, week 4, week 12
the scale of the physical and mental Health component summary score ranges from minimum 0 to maximum 100 points with higher scores indicating better quality of life
次要结局
- Change from baseline COVID-related symptoms at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline lung function at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline blood gas analysis at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline Cardiac Doppler echocardiography at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline laboratory parameters at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline exercise performance at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline health care service needs at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline working capability at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline sleep quality at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline Depression status assessed by Patient Health Questionnaire 9(baseline, week 4, week 12)
- Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7(baseline, week 4, week 12)
- Change from baseline resilience assessed by resilience scale 13(baseline, week 4, week 12)
- Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test(baseline, week 4, week 12)
- Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12(baseline, week 12)
- Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline physical activity assessed by Garmin watch at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline blood pressure assessed at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12(baseline, week 4, week 12)
- Change from baseline peak flow assessed by peak flow meter at week 4 and week 12(baseline, week 4, week 12)
研究者
Prof. Dr. Andreas Rembert Koczulla
Professor
Schön Klinik Berchtesgadener Land