Effects of Rehabilitation Combined With a 12-week Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19 - a Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from baseline quality of life assessed by Short-Form 12 questionnaire at week 4 and week 19
研究概览
简要总结
Infection with SARS-CoV-2 virus leads to persistent symptoms for more than 12 weeks in 15% of cases ("post-COVID syndrome"). Symptoms like fatigue, dyspnoea, limitations in physical performance and activities, head ache, anxiety symptoms, and depression are heterogenous which limit physical health and participation in daily life activities.
In the last years, multidisciplinary rehabilitation programs showed benefits in quality of life and symptom intensity in patients with post-COVID. Therefore, rehabilitation programs are recommended for individuals with Post-COVID by official sites like the German Society of Pulmonology and the European Respiratory Society.
Own first data (published at the ERS conference 2023) revealed that one the one hand, inpatient rehabilitation is effective, however, on the other hand, it is challenging to maintain these effects after completing the program. Therefore, the aim of this study is to sustain these benefits by using a digital maintenance program following the rehabilitation program compared to usual care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-COVID-syndrome (Definition WHO)
- •Entered the rehabilitation process at the Schoen Klinik Berchtesgadener Land
排除标准
- •No internet access
研究组 & 干预措施
Rehabilitation maintenance program
干预措施: Rehabilitation combined to a digital maintenance program (Procedure)
No Rehabilitation maintenance program
干预措施: Rehabilitation without maintenance program (Procedure)
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 19
时间窗: Baseline, week 4, week 19
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 exercise capacity at week 4 and week 19(Baseline, week 4, week 19)
- Change from the use of health care service at week 4 and week 19(Baseline, week 4, week 19)
- Change from rate of sickness at week 4 and week 19(Baseline, week 4, week 19)
- Change from baseline quality of life at week 4 and week 19(Baseline, week 4, week 19)
- Change from the use of medications at week 4 and week 19(Baseline, week 4, week 19)
- Change from workability at week 4 and week 19(Baseline, week 4, week 19)
- Change from ICF functionality at week 4 and week 19(Baseline, week 4, week 19)
- Change from cognition at week 4 and week 19(Baseline, week 4, week 19)
- Change from baseline post-COVID-related symptoms at week 4 and week 19(Baseline, week 4, week 19)
- Change from depression symptoms at week 4 and week 19(Baseline, week 4, week 19)
- Change from baseline physical activity at week 4 and week 19(Baseline, week 4, week 19)
- Change from anxiety symptoms at week 4 and week 19(Baseline, week 4, week 19)
- Change from resilience at week 4 and week 19(Baseline, week 4, week 19)
- Change from baseline lung function at week 4 and week 19(Baseline, week 4, week 19)
- Change from baseline fatigue symptoms at week 4 and week 19(Baseline, week 4, week 19)
- Change from sleep quality at week 4 and week 19(Baseline, week 4, week 19)
- Change from cognitive impairment at week 4 and week 19(Baseline, week 4, week 19)
研究者
Prof. Dr. Andreas Rembert Koczulla
Head of pulmonology, head of institute for pulmonary rehabilitation research
Schön Klinik Berchtesgadener Land