Clinical trial NCT05119634: The Effect of Whole Body Vibration Training in Individuals With Post COVID - 19
Official title: The Effect of Whole Body Vibration Training in Individuals With Post COVID - 19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: post COVID -19
whole body vibration
exercise
physical performance
physical activity
muscle strength
pulmonary function
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: there will be two groups: control and case. case group will recepe whole body vibration and control group will recepe only breathing exercise and some physical exercises
Primary purpose: TREATMENT

Brief summary: COVID -19 survivors need rehabilitatition for recovery. Our study aims to examine the effect of Whole Body Vibration Training in COVID-19 survivors

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* positive PCR result
* post covid (≥12 weeks) patients aged 18 and over

Exclusion Criteria:

* 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

Primary outcomes:
measure: 6 minutes walking test
timeFrame: 8 weeks
measure: 6 minutes pegboard and ring test
timeFrame: 8 weeks
measure: International Physical Activity Form (IPAQ)
timeFrame: 8 weeks
measure: activity monitoring with Actigraf GT3X
timeFrame: 8 weeks
measure: peripheral muscle strength measurement
timeFrame: 8 weeks
measure: pulmonary function test
timeFrame: 8 weeks
Secondary outcomes:
measure: Post-COVID-19 Functional Status Scale
timeFrame: 8 weeks
measure: Chalder Fatigue Questionnaire
timeFrame: 8 weeks
measure: Clinical Frailty Scale
timeFrame: 8 weeks
measure: EuroQol- 5 Dimension
timeFrame: 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 8 weeks
measure: Impact of Events Scale (IES-R)
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
measure: static posturography device (TETRAX®)
timeFrame: 8 weeks
measure: sit to stand test
timeFrame: 8 weeks
measure: Visual Analog Scale
timeFrame: 8 weeks
measure: Nordic scale
timeFrame: 8 weeks
measure: Charlson Comorbidity Index
timeFrame: 8 weeks
measure: COVID - 19 Yorkshire Rehab Screen Tool ( The C19- YRS)
timeFrame: 8 weeks
measure: Modified Medical Research Council dyspnea scale
timeFrame: 8 weeks
measure: Modified Borg Dyspnea Scale
timeFrame: 8 weeks
measure: The Lawton-Brody Instrumental Activities of Daily Living
timeFrame: 8 weeks
measure: Barthel index
timeFrame: 8 weeks
measure: Short Physical Performance Battery
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
state: Fatih
Study officials:
References:
citation: Sanudo B, Seixas A, Gloeckl R, Rittweger J, Rawer R, Taiar R, van der Zee EA, van Heuvelen MJG, Lacerda AC, Sartorio A, Bemben M, Cochrane D, Furness T, de Sa-Caputo D, Bernardo-Filho M. Potential Application of Whole Body Vibration Exercise For Improving The Clinical Conditions of COVID-19 Infected Individuals: A Narrative Review From the World Association of Vibration Exercise Experts (WAVex) Panel. Int J Environ Res Public Health. 2020 May 22;17(10):3650. doi: 10.3390/ijerph17103650.