The Effect of Whole Body Vibration Training in Individuals With Post COVID - 19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 6 minutes walking test
研究概览
简要总结
COVID -19 survivors need rehabilitatition for recovery. Our study aims to examine the effect of Whole Body Vibration Training in COVID-19 survivors
详细描述
COVID - 19 is an infectious disease caused by sars-CoV-2 that mainly affects the respiratory system. Most people experience mild to moderate respiratory illness and recover without special treatment. However, the need for hospitalization and mechanical ventilation is also quite high. Symptoms such as respiratory failure, dry cough, dyspnea, fatigue, weakness after exertion, headache, stress, depression, insomnia are frequently seen and require rehabilitation. Appropriate and tailored exercise stands as a promising, effective treatment to alleviate post-COVID-19 symptoms and help people recover faster and improve their autonomy, functionality and quality of life. In this context, Whole Body Vibration Training, which has been successfully applied to treat symptoms in many diseases such as COPD, can be used. Our study also aims to examine the effect of Whole Body Vibration Training in post COVID-19 patients. For this purpose, post COVID - 19 (≥12 weeks) patients aged 18 and over who applied to Cerrahpasa Medical Faculty, Department of Chest Diseases will be recruited. Lack of clinical stability, active respiratory infection, any clinical condition that interferes with the performance of working procedures, advanced cancer, active infectious disease, pregnancy or breastfeeding, osteoarticular pathology that reduces mobility, severe neurological disease (Parkinson's disease, dementia, amyotrophic lateral sclerosis, aphasia, ischemic stroke with significant sequelae), symptomatic psychiatric disease, hearing or visual impairment, myocardial infarction within 4 months, acute endocarditis/pericarditis, uncontrolled high blood pressure (>180/100 mmHg), other cardiovascular morbidity that may limit exercise tolerance (heart failure, patients with abnormal blood pressure responses or ST segment depression > 2mm, symptomatic aortic stenosis, complex arrhythmias), acute thromboembolism, recent upper abdominal or thoracic surgery (≤ 3 months) will not be included in the study. This study will be a double blind randomized controlled trial. Another clinican will coach patients and the researcher will have no idea about groups. There will be two groups in the study. Vibration at 25-40 Hz (with a total of 15-30 minutes and ≥3 minutes rest periods) will be applied to the case group 3 days a week for 8 weeks. The control group will do the determined exercises as a home based program. In this study, respiratory functions (with spirometry), dyspnea (with Modified Medical Research Council (MMRC) dyspnea scale, Modified Borg Dyspnea Scale), functional capacity (with 6 minutes walking test, 6 minutes pegboard and ring test, Post-COVID-19 Functional Status Scale- 19 (PCFS), fatigue (with Chalder Fatigue Questionnaire (CFQ-11), VAS), quality of life (with EuroQol-5D), anxiety and depression (Hospital Anxiety and Depression Scale (HADS), and Impact of Events Scale (IES) -R), frailty (with Clinical Frailty Scale (CFS), activities of daily living (with Lawton-Brody Instrumental Activities of Daily Living (iADL) scale and Barthel index), balance (with static posturography device (TETRAX®) and sit to stand test), peripheral muscle strength (with Portable Hand Dynamometer), physical activity (with Actigraf GT3X Device and International Physical Activity Form (IPAQ), sleep (with Pittsburgh Sleep Quality Index), pain (with NORDIC scale), symptoms ( Charlson Comorbidity Index, COVID - 19 Yorkshire Rehab Screen Tool and patients' self-report), physical performance (with Short Physical Performance Battery) will be evaluated.
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 (Participant, 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
- •positive PCR result
- •post covid (≥12 weeks) patients aged 18 and over
排除标准
- •Unstable chronic illness (unstable angina, unstable heart failure, uncontrolled arrhythmia, hypertension, and diabetes)
- •Recent history of myocardial infarction (<3 months)
- •Active oncological disease
- •Pregnancy or lactation status
- •Major surgical history (<3 months)
- •Orthopedic, neurological, or psychiatric disorders that would hinder participation in an exercise program
- •Hearing or visual impairment
研究组 & 干预措施
case group
patients will receive whole body vibration training 3 days in a week for 8 weeks
干预措施: whole body vibration training (Other)
case group
patients will receive whole body vibration training 3 days in a week for 8 weeks
干预措施: home based exercises (Other)
control group
participants will receive a home based exercise program
干预措施: home based exercises (Other)
结局指标
主要结局
6 minutes walking test
时间窗: 8 weeks
it evaluates submaximal aerobic capacity. The participants are asked to walk as far as possible in a 30-meter corridor in 6 minutes. Higher walking distance shows better outcome. Minimal clinical difference will be accepted 20-30 meter. Before and after the test, heart rate and blood pressure will be noticed and pulse oximeter will measure O2 saturation and heart rate during the test.According to Borg scale, dyspnea and fatigue level will be determined before and after teh test. Oxygen will be provided immediately following exercise for patients who desaturate (SpO2 \<88%), or as needed.
6 minutes pegboard and ring test
时间窗: 8 weeks
The 6PBRT is a simple, inexpensive test that evaluates both arm function and endurance. the participants moved 10 lightweight wooden rings each of the lower pegs to the upper pegs using both hands simultaneously during 6 minutes. Paticipants are asked to sit straight in a chair and a pegboard with multiple peg positions is placed in front of the subject at arm's length from the body. The final score is the total number of rings moved during the 6-minute period. Participants are permitted to stop and rest during the test if they feel severe dyspnea, fatigue, or other discomfort, and continue moving the pegs as soon as they can. Subjects are asked to score the perceived dyspnea and fatigue after the test by the Borg scale. Each subject performe the PBRT twice. A pulse oximeter is used to monitor heart rate (HR) and arterial oxygen saturation (Sao2), and measure blood pressure (BP).
International Physical Activity Form (IPAQ)
时间窗: 8 weeks
The International Physical Activity Questionnaire (IPAQ) is a commonly used physical activity questionnaire that assesses the amount and intensity of physical activity in daily living. The questionnaire comprises nine items to assess the level of physical activity (PA) at moderate (4 metabolic equivalent task, METS) and vigorous intensities (8 METS), walking (3.3 METS), and sitting times. The score of overall PA will be calculated in (MET)-min/week units, which is the sum of each mode of activity multiplied by the constant level of energy (MET) required for the task, as described above, by number of minutes will be performed per day, and by the amount of time performed per week. Based on questionnaire's manual, 600 METS-min/week (150 min/week \* 4METS of moderate intensity PA) is considered a threshold for meeting the general PA recommendation
activity monitoring with Actigraf GT3X
时间窗: 8 weeks
It is a triaxial accelerometer that measures body acceleration per unit time. It is possible to measure activity at different intensities using defined cut off points for accelerometer counts. Participanys wear the device for seven consecutive days, wearing it on an elastic waistband, and instructed to place it on their dominant side on the anterior axillary line of the hip.
peripheral muscle strength measurement
时间窗: 8 weeks
Quadriceps femoris and biceps brachii isometric muscle strength will be measured by portable hand dynamometer (JTECH, Medical Commander Powertrack II, USA). Isometric muscle strength of Quadriceps femoris and biceps brachii is measured by portable hand dynamometer. Quadriceps femoris muscle force is measured in sitting position, at knee extension, and biceps brachii muscle strength at backrest position, while elbow is flexed. For handgrip strength test, we wiil use a JAMAR dynamometer. Hand grip strength will be measured in an upright position, shoulder adduction, elbow 90° flexion, and wrist with thumb facing up. The measurements are repeated three times in succession and the average is recorded.
pulmonary function test
时间窗: 8 weeks
The pulmonary function test (PFT) will be performed with a portable spirometry device (Spirobank II) with the nose closed and at least three times in the sitting position. After the nose is tightened with a latch, the person breathes normally on the spirometer. After a few normal inspirations and expirations, it is desirable to take a deep breath at the end of the expiration at the level of rest, and to release the air slowly and continuously afterwards. With this application, the volumes and capacities outside the residual volume (RV), functional residual capacity (FRC) and total lung capacity (TLC) are calculated.
次要结局
- sit to stand test(8 weeks)
- Post-COVID-19 Functional Status Scale(8 weeks)
- Modified Borg Dyspnea Scale(8 weeks)
- Chalder Fatigue Questionnaire(8 weeks)
- Clinical Frailty Scale(8 weeks)
- EuroQol- 5 Dimension(8 weeks)
- Hospital Anxiety and Depression Scale (HADS)(8 weeks)
- Impact of Events Scale (IES-R)(8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(8 weeks)
- static posturography device (TETRAX®)(8 weeks)
- Visual Analog Scale(8 weeks)
- Nordic scale(8 weeks)
- Charlson Comorbidity Index(8 weeks)
- COVID - 19 Yorkshire Rehab Screen Tool ( The C19- YRS)(8 weeks)
- Modified Medical Research Council dyspnea scale(8 weeks)
- The Lawton-Brody Instrumental Activities of Daily Living(8 weeks)
- Barthel index(8 weeks)
- Short Physical Performance Battery(8 weeks)
研究者
Nihal Sakalli
principal investigator
Istanbul University - Cerrahpasa
