Effectiveness of a Multimodal Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Modified Borg scale.
研究概览
简要总结
The evolution of Coronavirus disease 2019 (COVID-19) pandemic makes it more necessary the intervention of Primary Health Care Physiotherapy Units in patients with respiratory and/or functional sequelae after suffering from SARS-CoV-2 (acute respiratory sindrome by coronavirus) virus infection.
Since some months ago, Primary Health Care use telerehabilitation tools to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing physical therapy interventions to patients' complications after COVID-19 by using a videoconferencing method. The aim of this study is to evaluate the effectiveness of a multimodal Physical Therapy telerehabilitation program in persistent post COVID-19 symptoms in Primary Health Care.
详细描述
Coronavirus disease 2019 (COVID-19), is a multisystem infectious disease which has led to a global pandemic. The evolution of COVID-19 disease makes it more necessary the intervention of Primary Health Care Physiotherapy Units in patients with respiratory and /or functional sequelae after suffering from SARS-CoV-2 infection. Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with persistent post COVID-19.
Since some months ago, Primary Health Care use telerehabilitation tools to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing physical therapy interventions to patients' complications after COVID-19 by using a videoconferencing method. The aim of this study is to evaluate the effectiveness of a multimodal Physical Therapy telerehabilitation program in persistent post COVID-19 symptoms in Primary Health 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
- Double (Investigator, Outcomes Assessor)
盲法说明
The Principal Investigator and the assessor will be blinded to the randomization and allocation. The assessor will have not access to patients' medical record. Patients will be also asked to do not explain about their procedure to the assessor.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with long post-COVID symptoms (from week 12 to week 24).
- •Patients between 25 and 70 years old.
- •Patients with moderate respiratory and/or functional affectation with long post COVID-19 symptoms, belonging to four Physiotherapy Units of primary Health Care in Madrid (Spain).
- •Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.
- •Persistent symptoms lasting ≥12 weeks since the first positive test, including dyspnea (new or increased from baseline as measured by modified Medical Research Council (mMRC) score ≥1).
- •Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.
- •Participant owns a smart phone, tablet, or computer to access on-line sessions.
排除标准
- •People with symptoms such as fever, cough, upper respiratory distress, diarrhea, vomiting, anosmia or ageusia.
- •Temperature greater than 37.2 degrees Celsius.
- •Patients with multimorbidity. Multimorbidity will be considered when the patient is diagnosed with two or more diseases among the following: diabetes, dyslipidaemia, cardiovascular disease (arterial hypertension, ischemic heart disease, valvular heart disease, heart failure), osteoarthritis, respiratory disease (asthma, chronic bronchitis), digestive disease ( gastric or duodenal ulcers, inflammatory bowel disease, liver disease), psychiatric pathology or tumor pathology.
- •Patients with previous pathologies: ischemic heart disease, dementia, lung failure, lung cancer, cystic fibrosis, pulmonary fibrosis, chronic kidney failure, liver diseases, myocardial arrhythmias, deep vein thrombosis, severe aortic stenosis, liver diseases.
- •Patients with weakened immune systems: in cancer treatment, organ or marrow transplant patients, HIV/AIDS, prolonged use of prednisone or similar medication.
- •Patients with functional limitations to carry out their basic activities of daily living. Barthel index greater than
- •Patients with cognitive problems. Mini-Cognitive Lobo exam greater than 23 points
- •Active bleeding.
- •Unstable fractures.
结局指标
主要结局
Modified Borg scale.
时间窗: 14 weeks.
Modified Borg scale, or scale of perceived exertion, is a subjective scale to measure the intensity of a physical effort, quantifying the respiratory distress. The modified Borg Scale is averaged from 0 to 10. Perceived effort will be measured as 0-2 (light effort), 3-4 (moderate effort), 5-6 (hard effort), 7-9 (very hard effort) and 10 (maximum effort).
次要结局
- Saint George Respiratory Questionnaire.(14 weeks.)
- Modified Medical Research Council Dyspnea Score.(14 weeks.)
- 6-Minute Walk Test (6MWT).(14 weeks.)
研究者
MARIA JOSE DIAZ ARRIBAS
University Professor
Universidad Complutense de Madrid