Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evaluation of peripheral muscle oxygenation
研究概览
简要总结
This study was carried out in the post-acute period of the telerehabilitation program in individuals with dyspnea who had COVID-19; It will be done to examine the effects on dyspnea, exercise capacity, respiratory functions, activities of daily living, muscle strength, muscle oxygenation, fatigue and quality of life parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75,
- •Do not have any orthopedic or neurological disease that will affect exercise capacity,
- •Individuals who can take and execute verbal orders,
- •Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment,
- •Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house),
- •Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)),
- •Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale.
排除标准
- •Those who have not had COVID-19 or acute period patients who are experiencing COVID-19,
- •Individuals who cannot be contacted,
- •Individuals with chronic heart disease,
- •Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%),
- •Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years),
- •Individuals with cerebrovascular disease in the last 6 months,
- •Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis,
- •Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR),
- •Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months,
- •Individuals who cannot walk independently,
- •Individuals with any mental illness that may prevent them from living independently or receiving treatment,
- •Uncooperative individuals for assessment and rehabilitation programs,
- •Those with alcohol or substance addiction,
- •Those who are pregnant, suspected of pregnancy or considering becoming pregnant,
- •Participants in another study within the last 3 months or currently.
结局指标
主要结局
Evaluation of peripheral muscle oxygenation
时间窗: 6 weeks
"Moxy muscle oxygen monitor" will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle. Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation. A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
Respiratory Muscle Strength
时间窗: 6 weeks
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
Quality of life assessment
时间窗: 6 weeks
The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary. is done. High scores indicate good health.
Pulmonary function (FEV1 / FVC)
时间窗: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Pulmonary function (Peak flow rate (PEF)
时间窗: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.
Physical activity level assessment
时间窗: 6 weeks
The physical activity level of the participants will be evaluated with the Turkish version of the "International Physical Activity Questionnaire" (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned. All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
Severity of dyspnea assessment
时间窗: 6 weeks
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
Activities of daily living assessment
时间窗: 6 weeks
Barthel Index will be used to evaluate activities of daily living.
Perceived fatigue assessment
时间窗: 6 weeks
Participants' perceived fatigue level will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers. consists of corresponding definitions It will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue.
Cardiopulmonary endurance assessment
时间窗: 6 weeks
In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied. The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track. The distance the person walks for 6 minutes is recorded in meters.
Pulmonary function (slow vital capacity)
时间窗: 6 weeks
Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice. It is a measure of how much you can count in your cadence.
Pulmonary function (Forced vital capacity (FVC))
时间窗: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Pulmonary function (Forced expiratory volume in the first second (FEV1))
时间窗: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Muscle strength assessment
时间窗: 6 weeks
Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
General fatigue assessment
时间窗: 6 weeks
Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month. The maximum total score is 33; 4 and above scorers are described as tired.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
时间窗: 6 weeks
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
次要结局
未报告次要终点
研究者
Canan Demir
Research Assistant
Bandırma Onyedi Eylül University