跳至主要内容
临床试验/NCT05094622
NCT05094622进行中(未招募)不适用

Physical Exercise in Patients With Postural Orthostatic Tachycardia Syndrome (POTS) After Covid-19.

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Change in Health-Related Quality of Life (HRQoL)

研究概览

简要总结

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 may need specialized rehabilitation to be able to meet the complex symptoms and problems that may arise. A more specific syndrome that seems to occur more frequently than expected in the group of non-hospitalized patients who have had Covid-19 is the postural orthostatic tachycardia syndrome (POTS).

To evaluate the effects of physical training in patients with POTS after Covid-19 a single subject design will be used (the patient is their own control). Inidividual semistructured interviews will be performed to explore and describe the patients´ experiences of the rehabilitation intervention.

Participants: Patients diagnosed with POTS after Covid-19 (N=30) will be included.

Procedure and outcomes: The primary outcomes are physical activity and health-related quality of life. Secondary outcomes are: physical capacity, active standing test, Malmö-POTS-questionnaire, Anxiety and depression, fatigue, self-reported outcome measure of physical function and work ability.

Initially measurements will be performed several times during a period of 2-4 weeks to obtain a baseline before the intervention starts. Then the included participants will undergo a specially designed physical training program that will be performed 3 times /week during a period of 12 weeks. The intervention of physical training will consist of different exercises to enhance muscle strength and endurance. The intervention will be individually adjusted with a progression in dose, intensity, and position. The exercise is based on a program used in a previous study. Measurements will then be repeated after completion of the intervention period.

A qualitative approach, with semistructured interviews, will be used to explore the patients´ experiences of the intervention, after commence of the interventional trial.

详细描述

Introduction:

Covid-19 was declared a global pandemic in March 2020 by the World Health Organization (WHO). In August 2021, in Sweden, over 1 100 000 cases were confirmed and over 14 000 deaths. 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 more specific syndrome that seems to occur more frequently than expected in persons who have had Covid-19 is the postural orthostatic tachycardia syndrome (POTS). It is a form of chronic orthostatic intolerance in which upright posture is associated with an excessive increase in heart rate (HR) with a >6-month history of symptoms. Patients with POTS may have problems associated to the diagnoses, such as palpitation exercise intolerance, hypermobile joints, exercise intolerance, migraine headaches, brain-fog, sleep disturbances, and fatigue. Symptoms that can be exacerbated by simple activities of daily life and exercise. Consequently, patients seem to reduce their physical activity, which might reduce their physical capacity and function and thus limit activities in daily living.

Nevertheless, supervised individual tailored physical exercises, is a recommended non-pharmacological treatment of POTS. However, few studies have investigated the effect of physical exercise in POTS, and to date, no studies have evaluated the effect of individually tailored rehabilitation in persons with POTS after Covid-19.

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

入选标准

  • Adult patients (>18 years) diagnosed with postural orthostatic tachycardia syndrome after Covid-19.

排除标准

  • Patient not able to perform the intervention due to cognitive or physical dysfunction, Already on-going physical intervention.

研究组 & 干预措施

Physical exercise

Experimental

Physical exercise program

干预措施: Physical exercise program (Other)

结局指标

主要结局

Change in Health-Related Quality of Life (HRQoL)

时间窗: Measured before and after the intervention period of 12-16 weeks to detect a change

Measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL.

Change in time in upright position and steps per day

时间窗: Measured before and after the intervention period of 12-16 weeks to detect a change

Measured with two accelerometers attached to upper and lower limbs to measure time (hours, minutes) in upright position during 7 consecutive days

次要结局

  • Change in walking distance during 6 minute walk test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in oxygen desaturation during 6 minute walk test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in oxygen saturation during 6 minute walk test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in leg fatigue during 6 minute walk test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in heart rate during 6 minute walk test(Measured before and after the intervention period of 12-16weeks to detect a change)
  • Change in Anxiety - Generalised Anxiety Disorder 7-item scale(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in Depression - Patient Health Questionnaire-9(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in Work ability(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in orthostatic symptoms(Measured before and after the intervention period of 12-16 weekt to detect a change)
  • Change in dyspnea during 6 minute walk test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in exertion during 6 minute walk test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in Self-reported outcome measure of physical function(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in oxygen saturation during Active standing test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in Self-reported POTS-symptoms(Measured before and after the intervention period of 20 weeks to detect a change)
  • Change in heart rate response during Active standing test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in dyspnea during Active standing test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in exertion during Active standing test(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in Physical activity(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in Fatigue(Measured before and after the intervention period of 12-16 weeks to detect a change)
  • Change in blood pressure during Active standing test(Measured before and after the intervention period of 12-16 weeks to detect a change)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Malin Nygren-Bonnier

Physiotherapist, Senior lecturer and Associate Professor

Karolinska Institutet

研究点 (2)

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