The Effect of Whole Body Vibration Training in Individuals With Post COVID - 19

April 22, 2025 updated by: Nihal Sakalli, Istanbul University - Cerrahpasa
COVID -19 survivors need rehabilitatition for recovery. Our study aims to examine the effect of Whole Body Vibration Training in COVID-19 survivors

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey
        • İstanbul University Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: case group
patients will receive whole body vibration training 3 days in a week for 8 weeks
Other: whole body vibration training
participants will receive whole body vibration training 3 days in a week and for 8 weeks
Other Names:
  • exercise training
Other: home based exercises
participants will receive a home based exercise program for 8 weeks
Active Comparator: control group
participants will receive a home based exercise program
Other: home based exercises
participants will receive a home based exercise program for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 minutes walking test
Time Frame: 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.
8 weeks
6 minutes pegboard and ring test
Time Frame: 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).
8 weeks
International Physical Activity Form (IPAQ)
Time Frame: 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
8 weeks
activity monitoring with Actigraf GT3X
Time Frame: 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.
8 weeks
peripheral muscle strength measurement
Time Frame: 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.
8 weeks
pulmonary function test
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery
Time Frame: 8 weeks
it will be used to measure physical performance. The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function. The scores range from 0 (worst performance) to 12 (best performance).
8 weeks
Post-COVID-19 Functional Status Scale
Time Frame: 8 weeks
it monitors the course of symptoms and their impact on the functional status of patients. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death, D), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle
8 weeks
Chalder Fatigue Questionnaire
Time Frame: 8 weeks
Fatigue will be assessed using the Chalder fatigue scale (CFQ-11). It contains 11 items on an ordinal 0 to 3 scale, which are summed to a total score (range 0-33; 33 denotes maximal symptoms) and two subscales: physical fatigue (seven items, range 0-21) and mental fatigue (four items, range 0-12). The CFQ-11 also has an alternative scoring algorithm, bimodal scoring, where each item response is dichotomized; 0 (0 to 1) or 1 (2 to 3) and summed to a 0-11 scale. Conventionally, fatigue case-status (fatigued vs. non-fatigued) is defined using this scale with a cut-off at <4 vs. ≥4
8 weeks
Clinical Frailty Scale
Time Frame: 8 weeks
It is a method in which activities of daily living and comorbid conditions are evaluated, where 1 point denotes very fit individuals and 9 points denotes highly fragile individuals (terminal patients, individuals with a life expectancy of less than 6 months) and clinical decision is effective. In many studies, clinical frailty scale has been shown to be effective in predicting outcomes such as mortality and length of stay in hospitalized patients.
8 weeks
EuroQol- 5 Dimension
Time Frame: 8 weeks
The EQ-5D is a validated, generic, preference-based, health-status measure consisting of five descriptive questions concerning five domains of HRQoL (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression). Each question is answered with one of the three potential responses as follows: (1) 'no problems', (2) 'moderate problems' and (3) 'severe problems.' An index score ranging from -0.59 to 1 is calculated from the 5 dimensions of the scale. In the score function, a value of 0 indicates death, a value of 1 indicates perfect health, while negative values indicate conditions such as unconsciousness and being confined to a bed.
8 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 8 weeks
The Hospital Anxiety and Depression Scale (HADS) is a brief and widely used instrument to measure psychological distress. It provides a HADS-depression (HADS-D) and a HADS-anxiety (HADS-A) score. Both total scores range from 0 to 21. At the end of the validity study conducted in Turkey, the cut-off score for the anxiety subscale was found to be 10/11 and 7/8 for the depression subscale. Accordingly, those who score above these points are considered as a risk group.
8 weeks
Impact of Events Scale (IES-R)
Time Frame: 8 weeks
The scale consists of 22 items that measure the subjective stress levels of individuals exposed to traumatic life events. Each item is evaluated on a 5-point Likert-type scale (0 = Never, 4 = Always). The scale consists of three subscales: hyperarousal, avoidance, and intrusion. The IES-R subscores were categorized as normal (0-23 IES-R points), mild (24-32 IES-R points), moderate (33-36 IES-R points), and severe psychological impact of events (>37 IES-R points).
8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 weeks
The PSQI allows evaluating the quality and disturbances of sleep over one month. The questionnaire consists of 19 self-assessed questions that are categorized into 7 components: 1) sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disorders, 6) medication use to sleep, and 7) daytime sleepiness. Each component is classified in a score ranging from 0 to 3. The sum of the scores for these 7 components produces a score ranging from 0 to 21. It presents a cutoff point where it considers good sleep quality if PSQI≤5 and poor sleep quality if PSQI>5
8 weeks
static posturography device (TETRAX®)
Time Frame: 8 weeks
Static posturography formed with four separate plates and each force plate measures the perpendicular pressure of the anterior and posterior feet. Participants took off their shoes, positioned their feet on the plates, and stood in a comfortable position. Eight different postures were evaluated for the test and each posture was measured for 32 seconds. For the postural variable factors, the stability index (ST), Fourier index, weight distribution index (WDI), and the synchronization index (SI) are measured.
8 weeks
sit to stand test
Time Frame: 8 weeks
this will be used for both balance and Short Physical Performance Battery. It is a test based on crossing the patient's hands at the chest and making the most repetition possible by sitting and lifting continuously for 30 seconds. The number of sit down and stand up is recorded by the physiotherapist.
8 weeks
Visual Analog Scale
Time Frame: 8 weeks
The Visual Analog Scale is frequently used in many clinical and epidemiological studies to evaluate the intensity and frequency of symptoms, especially pain, in patients. It is a table that evaluates between 0-10 or 0-100, which is used to convert these values that cannot be measured numerically. we will use this for pain and fatşgue assessment
8 weeks
Nordic scale
Time Frame: 8 weeks
This scale questions the location and localization of pain on a body chart. The Standardized Nordic Questionnaire is a standardized international tool used to assess musculoskeletal complaints. The presence of musculoskeletal symptoms was defined as pain, soreness, or discomfort in one of nine areas of the body. These regions; neck, shoulder, upper back, elbow, wrist, lower back, hip, knee and ankle.
8 weeks
Charlson Comorbidity Index
Time Frame: 8 weeks
It was developed by M. E. Charlson in 1987 for the long-term prognosis of patients. The Charlson comorbidity index has been a useful tool for researchers in studies of measuring comorbidity in health databases. 19 comorbid diseases are scored based on the relative risk of one-year mortality. The patient's age is then added to the comorbidity score. In conclusion, the index score sum has been shown to be an indicator of disease burden and useful in predicting mortality for COVID-19 patients.
8 weeks
COVID - 19 Yorkshire Rehab Screen Tool ( The C19- YRS)
Time Frame: 8 weeks
The C19-YRS was used to record patients' symptoms, functioning, and disability. A global health question was used to measure the overall impact of Post COVID syndrome on health.
8 weeks
Modified Medical Research Council dyspnea scale
Time Frame: 8 weeks
It is a scale developed to evaluate patients' degree of dyspnea more objectively. It includes activities that provoke the feeling of breathlessness, such as walking and climbing stairs with 5 points. In less than a minute, the patient will select a score from the MMRC scale based on their degree of dyspnea. The MMRC scale is defined as a differential tool that categorizes patients according to their disease level.
8 weeks
Modified Borg Dyspnea Scale
Time Frame: 8 weeks
It is a scale that is frequently used to evaluate the severity of dyspnea on exertion and the severity of dyspnea at rest. It consists of ten items describing the severity of dyspnea according to their degrees.
8 weeks
The Lawton-Brody Instrumental Activities of Daily Living
Time Frame: 8 weeks
The Lawton-Brody Instrumental Activities of Daily Living is an appropriate tool for assessing independent living skills. The function measured with this scale has 8 fields. These include the ability to use the telephone, shopping, preparing meals, housekeeping, laundry, mode of transportation, medication responsibility, and financial management. The maximum score that can be obtained from the scale is 17, and the minimum score is 0.
8 weeks
Barthel index
Time Frame: 8 weeks
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel includes 10 personal activities: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. The possible score is between 0-100 (0-20 points fully dependent, 21-61 points highly dependent, 62-90 points moderately dependent, 91-99 points mildly dependent, 100 points fully independent).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSakalli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

outcomes and method will be share

IPD Sharing Time Frame

the data will become available by 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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