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

NCT05119634 | Completed DMC

• 1 other identifier: NSakalli
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

post COVID -19; whole body vibration; exercise; physical performance; physical activity; muscle strength; pulmonary function

Outcome Measures

Primary Outcomes (6)

• 6 minutes walking test

  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

  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)

  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

  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

  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

  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 Outcomes (18)

• Post-COVID-19 Functional Status 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

Study Arms (2)

case group

EXPERIMENTAL

patients will receive whole body vibration training 3 days in a week for 8 weeks

Other: whole body vibration training; Other: home based exercises

control group

ACTIVE COMPARATOR

participants will receive a home based exercise program

Other: home based exercises

Interventions

whole body vibration training OTHER

participants will receive whole body vibration training 3 days in a week and for 8 weeks

Also known as: exercise training

case group

home based exercises OTHER

participants will receive a home based exercise program for 8 weeks

case group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, fatih, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32455961 BACKGROUND

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: November 15, 2021
• Study Start: September 30, 2021
• Primary Completion: October 21, 2022
• Study Completion: January 10, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: the data will become available by 2022

Locations

TU (1)