Effects of Inspiratory Muscle Training After Covid-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
Initially, it was suspected that Covid-19 would primarily affect the airways, but several studies have now shown that it is a disease with multisystem manifestations. Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. The term post-acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection. Patients who have been in hospital for Covid-19 for a long time may need specialized rehabilitation, however, also non-hospitalized patients with mild symptoms may need specific rehabilitation to be able to meet the complex symptoms and problems that may arise. Previous studies on the recovery and rehabilitation after other coronavirus shows the importance to develop tailored interventions so that these patients receive appropriate rehabilitation
The aim of this study is to evaluate the effects of inspiratory muscle training on adult patients with PACS and decreased respiratory muscle strength.
A randomized controlled trial will be used. A total of 90 adult patients with PACS and 80 % or less of predicted value in inspiratory muscle strength (maximal inspiratory pressure) will be eligible for enrollment. Patients will be randomized either to an intervention group or a control group. The intervention will consist of inspiratory muscle training performed twice daily for 8 weeks. This will be combined with an 8-week physical exercise training program. The control group will perform the same physical exercise training according to standard care. All measurements will be performed at baseline and after 8 weeks.
Primary outcome is maximal inspiratory pressure. Secondary outcomes are: Maximal expiratory pressure, pulmonary function, physical capacity, physical activity, respiratory status and symptoms, health-related quality of life, work ability, fatigue, self-reported outcome measure of physical function and voice function.
Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways and lead to a negative impact on quality of life in the long-term perspective. Therefore, development of a rehabilitation program with specific tailored interventions will be necessary to improve physical and psychological function, as well as health-related quality of life and work ability.
详细描述
Introduction:
Covid-19 was declared a global pandemic in March 2020 by the World Health Organization (WHO). So far (August 2021), there are over 1 100 000 confirmed cases and over 14 000 deaths in Sweden. Initially, it was suspected that Covid-19 would primarily affect the airways, but several studies have now shown that it is a disease with multisystem manifestations. The impact of the virus ranges from an asymptomatic infection to a severe and life-threatening disease that can affect the cardiac, renal gastrointestinal, nervous, endocrine, and musculoskeletal systems. Therefore, Covid-19 has the potential to affect physical, cognitive, and psychological functions in multiple ways. It has been clear that a significant proportion of patients with Covid-19 develop long-term symptoms. Signs and symptoms may arise from any system in the body, often with significant overlap, and may develop over time. The term post- acute Covid-19 syndrome (PACS) is now used to describe the wide range of prolonged symptoms following the infection.
Fatigue, decreased physical and psychological function have been reported in the initial recovery phase, but still little is known on the long-term consequences. Patients who have been in hospital for Covid-19 for a long time may need specialized rehabilitation, however, also non-hospitalized patients with mild symptoms may need specific rehabilitation to be able to meet the complex symptoms and problems that may arise. Previous studies on the recovery and rehabilitation after other coronavirus shows the importance to develop tailored interventions so that these patients receive appropriate rehabilitation with a multi-professional approach throughout the whole care chain. Some studies suggest that the rehabilitation should be similar to pulmonary rehabilitation, but since a lot of patients often have symptoms from different organ systems this is not yet fully investigated and needs to be addressed from different perspectives. A study by Liu et al (2020), showed that 6 weeks of physical exercise and respiratory muscle training improved lung function and physical capacity compared to a control group in elderly patients after Covid-19.
At the Karolinska University Hospital there is a specialized multidisciplinary and multi-professional approach aiming to follow up patients who have been hospitalized. However, from mid-2020 and onwards, referrals from primary care have significantly increased. This includes patients who have never been hospitalized but with varying symptoms from several organs that have lasted for more than 3 months.
This study is part of a bigger research project (ReCoV) and is integrated with the clinical follow-up and linked research project of patients who have been hospitalized or referred from primary 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)
盲法说明
The interventions were not possible to mask for participants or health care professionals (physiotherapist leading interventions). The physiotherapists who performed the tests after interventions were blinded to the group allocation. All data were coded and group assignment was blinded for the outcome analyses.
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 (≥18 years) who have undergone Covid-19 and have 80% or less of the lower limit of predicted value in maximal inspiratory pressure (MIP).
排除标准
- •Physical och cognitive dysfunction which makes it impossible to carry out measurements and interventions. Already on-going intervention with inspiratory muscle training.
研究组 & 干预措施
Intervention: inspiratory muscle training + physical exercise
Inspiratory muscle training (IMT) twice a day for 8 weeks combined with a physical exercise program at least two times a week for 8 weeks.
干预措施: Inspiratory muscle training (IMT) (Other)
Intervention: inspiratory muscle training + physical exercise
Inspiratory muscle training (IMT) twice a day for 8 weeks combined with a physical exercise program at least two times a week for 8 weeks.
干预措施: Physical exercise (Other)
Active control: physical exercise
A physical exercise program at least two times a week for 8 weeks.
干预措施: Physical exercise (Other)
结局指标
主要结局
Change in Maximal Inspiratory Pressure (MIP)
时间窗: Measured before and after the intervention period of 8 weeks to detect a change
Change in MIP measured in cmH20, expressed as percentage of predictive value, with a Respiratory Pressure Meter (Micro RPM)
Change in Maximal Inspiratory Pressure (MIP)
时间窗: Measured before and after the intervention period of 8 weeks to detect a change
Change in MIP measured in cmH20, expressed as percentage of predictive value, with a Respiratory Pressure Meter (Micro RPM)
次要结局
- Change in Maximal Expiratory Pressure (MEP)(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Lung function(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in walking distance during 6 minute walk test, expressed as percentage of predictive value,(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen saturation during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen desaturation during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in dyspnea during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in leg fatigue during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in exertion during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in heart rate during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in number of stands in 30 seconds(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in number of stands in 60 seconds, expressed as percentage of predictive value.(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen saturation during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen desaturation during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in dyspnea during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in leg fatigue during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in exertion during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in heart rate during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Dyspnea - mMRC (decrease of >= 1)(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Health-related quality of life (EQ5d-index, EQ VAS)(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Work ability(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Fatigue (FSS-mean score )(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in self-reported outcome measure of physical function(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Voice function(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Respiratory symptoms(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Physical activity (Frändin/Grimby increase of >= 1 level)(Measured before and after the intervention period of 8 weeks to detect a change)
- Clinically meaningful improvements in MIP and EQ VAS(Changes between baseline and post-intervention assessment. Eight week intervention period.)
- Change in dyspnea during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in leg fatigue during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in exertion during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in heart rate during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in number of stands in 30 seconds(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen saturation during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen desaturation during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in dyspnea during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in leg fatigue during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in exertion during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in heart rate during chair stand test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Maximal Expiratory Pressure (MEP)(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in Lung function(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen saturation during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
- Change in oxygen desaturation during 6 minute walk test(Measured before and after the intervention period of 8 weeks to detect a change)
研究者
Malin Nygren-Bonnier
Physiotherapist, Senior lecturer and Associate Professor
Karolinska Institutet