Investigation of the Effects of Whole Body Vibration Application on Muscle Functional Level, Physical Fitness and Respiratory Parameters After Bariatric Surgery

NCT07602959 | Not Yet Recruiting

• 1 other identifier: IstinyeU
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to investigate the effects of whole body vibration on muscle functional level, physical fitness and respiratory parameters after bariatric surgery. Hypotheses of the study: H1: TVV after bariatric surgery has an effect on the functional level of the muscle. H2: TVV after bariatric surgery has an effect on physical fitness. H3: TVV after bariatric surgery has an effect on respiratory parameters. H4: TVV after bariatric surgery has an effect on quality of life. H5: TVV after bariatric surgery has an effect on body composition. H6: TVV after bariatric surgery has an effect on biochemical parameters. Patients will be divided into 3 randomized controlled groups. Whole body vibration application group, resistance exercise group and control group. The whole body vibration group will exercise on the device 3 days a week. Resistance exercise group will exercise with resistance band 3 days a week. All exercises will last 6 weeks. The whole body vibration, resistance exercise and control groups will be recommended to walk 7 days a week.

Conditions

Obesity & Overweight; Morbid Obesity; Morbid Obesity Requiring Bariatric Surgery

Keywords

bariatric surgery; whole body vibration; resistance exercise; physical fitness; respiration; functional level of muscle

Outcome Measures

Primary Outcomes (9)

• Muscle Ultrasound

  Measurements will be made using a 5-12 MHz probe. Muscle fascicle lengths, muscle thickness and pennate angles are measured. Sarcopenia mainly affects the lower extremity muscles more. Quadriceps muscle is one of the basic muscles that enable us to perform daily life activities such as walking and standing. The functionality of the quadriceps muscle allows us to have information about the quality of life of individuals. The gastrocnemius muscle is also one of the methods used to determine sarcopenic obesity by ultrasound (Deniz et al., 2020; Minetto et al., 2016; Perkisas et al., 2021). In a study conducted by Li et al. in 2020 with 179 geriatric individuals, the biceps brachii muscles of the participants were measured by ultrasound. In the study, it was observed that the cross-sectional area of the biceps brachii muscle was significantly reduced in sarcopenic elderly compared to non-sarcopenic elderly (Li et al., 2020).

  6 weeks

• Muscle Strength Measurement

  Peripheral muscle strength of shoulder abductor and adductor, shoulder flexor, extensor, elbow flexor and extensor, hip flexor, extensor, abductor and adductor, knee flexor and extensor muscles will be measured with a portable myometer (Model 01165, Lafayette, IN, USA). Hand grip strength will be measured with a hand dynamometer (Jamar, Nottinghamshire, England) in a sitting position, elbow flexed 90 degrees, wrist neutral. The measurements will be repeated three times for the right and left side and the best of the values obtained will be recorded in Newton (N) (Hébert et al., 2011).

  6 weeks

• Elasticity Evaluation of Muscle

  The tonus of quadriceps, gastrocnemius and biceps brachii muscles will be measured with MyotonPro™ device (Myoton AS, Talin, Estonia). The most bulging part of the muscle will be marked with a skin marker pen and the device will be placed perpendicular to the muscle. During the test, a 0.4N impulse is applied from the device to the skin with a force of 0.18N and a duration of 15 msec. Elasticity values (ms) of the muscle will be recorded on the screen of the device (Aird et al., 2012). The assessment point and position of the muscles will be measured according to the positions and criteria recommended on the Myoton®PRO official website (https://www.myoton.com/applications).

  6 weeks

• Respiratory Muscle Strength Assessment

  In the respiratory muscle strength assessment, the maximum inspiratory intraoral pressure (IMP) and maximum expiratory intraoral pressure (MEP) of the patients will be measured using a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O. MIP is the intraoral pressure measured during maximum inspiration against a valve closing the airway. For measurement, the subject is made to expire maximally and at the end of this, the airway is closed with a valve and the subject is asked to inspire maximally and maintain this for '1-3' seconds. MEP is the intraoral pressure measured during maximal expiration against a valve closing the airway. In MEP measurement, after the person performs maximal inspiration, the person is asked to perform maximal expiration for '1-3' seconds against the closed airway. The best of the three measurements will be selected. It will be expressed as a percentage of normal reference values calculated according to age and gender.

  6 weeks

• Respiratory Muscle Endurance

  In the dynamic method, peak inspiratory flow rate (PIF) and respiratory muscle strength index (S-index) will be assessed using the portable POWERbreathe K5 device (PowerBreathe K5, HaB International Ltd, Warwickshire, UK). Patients will perform at least 10 consecutive speed-dependent maneuvers (4.5 seconds between inspirations) in two different phases of the assessment sequence. Respiratory muscle endurance will be assessed using the POWERbreathe Classic respiratory muscle training device (PowerBreathe International Ltd, Warwickshire, UK) with an increasing workload test. The test will start with 30% of the MIP and the patient will be asked to breathe deeply with this workload for 2 minutes. For patients who have completed 2 minutes, the workload will be increased by 10% per minute. The final workload sustained for at least 1 minute will be recorded (Woszezenki et al., 2017, Silva et al., 2018).

  6 weeks

• Pulmonary Function Test

  In the pulmonary function test, patients' forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC), peak flow rate (PEF) will be measured with a portable spirometer. Pulmonary function test parameters will be expressed in liters and as a percentage of the expected value. Pulmonary function test will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Against the risk of infection, appropriate sterilization method recommended by the guideline, disposable, personalized mouthpieces and filters will be used (Ucok et al., 2010).

  6 weeks

• Cardiopulmonary Exercise Test

  In our study, CPET will be performed with a treadmill. Modified Bruce protocol will be applied. All participants will be informed about the device before starting the test. Situations that may require people to terminate the test will be explained. During the test, people will breathe in and out with a mask with a gas analyzer attached at the end so that the amount of oxygen they take in and carbon dioxide they exhale can be measured. Ventilation parameters will be obtained by analyzing and measuring the gases collected by gas analyzers and flow meters in each breath. Heart rate and ECG will be monitored during KPET. The test will be terminated if the person states that he/she cannot continue the exercise for any reason or if there are indications to terminate the exercise. During the test, VO2max, RER, HR, VO2/HR, maximum time, VE/VO2, VE/VCO2, VD/VT, VE, BF, BR, paCO2, VO2/kg, values will be recorded.

  6 weeks

• Stiffness of Muscle

  Description: The tonus of quadriceps, gastrocnemius and biceps brachii muscles will be measured with MyotonPro™ device (Myoton AS, Talin, Estonia). The most bulging part of the muscle will be marked with a skin marker pen and the device will be placed perpendicular to the muscle. During the test, a 0.4N impulse is applied from the device to the skin with a force of 0.18N and a duration of 15 msec. Stiffness (N/m) value of the muscle will be recorded on the screen of the device (Aird et al., 2012). The assessment point and position of the muscles will be measured according to the positions and criteria recommended on the Myoton®PRO official website (https://www.myoton.com/applications). Time Frame: 6 weeks

  6 weeks

• Tonus Evaluation of Muscle

  Description: The tonus of quadriceps, gastrocnemius and biceps brachii muscles will be measured with MyotonPro™ device (Myoton AS, Talin, Estonia). The most bulging part of the muscle will be marked with a skin marker pen and the device will be placed perpendicular to the muscle. During the test, a 0.4N impulse is applied from the device to the skin with a force of 0.18N and a duration of 15 msec. Tonus (Hz) value of the muscle will be recorded on the screen of the device (Aird et al., 2012). The assessment point and position of the muscles will be measured according to the positions and criteria recommended on the Myoton®PRO official website (https://www.myoton.com/applications). Time Frame: 6 weeks

  6 weeks

Secondary Outcomes (3)

• Biochemical Analyses

  6 weeks

• Body Composition Analysis

  6 weeks

• Assessment of Quality of Life

  6 weeks

Study Arms (3)

intervention group- resistance exercise

EXPERIMENTAL

The resistance exercise training group will be given resistance exercise with theraband for 6 weeks in addition to the conventional physiotherapy program. The exercise protocol will be performed 3 days a week, 1 time a day, 1 day supervised. The evaluation sessions of the individuals will be face to face. Sessions will start with a 5-minute warm-up exercise, resistance exercise protocol will be applied, and will end with a 5-minute cool-down exercise. Rest periods of 2-3 minutes will be given between sets. Before and after each exercise, heart rate, blood pressure, SpO2, dyspnea and fatigue values will be measured according to the Modified Borg Scale. They will be asked to be between 4-6 (moderate) according to the scale during the exercise. After finding 1 RM of the individuals, 50% of this value will be taken for exercise loads between 0-2 weeks. According to the corresponding value of this value in the elastic resistance band, the appropriate band color will be selected and the per

Other: Resistance Training

intervention group- whole body vibration

EXPERIMENTAL

The WBV training group will be given exercises on the WBV device in addition to the conventional physiotherapy program. The exercise protocol will be performed face to face, 3 days a week, 1 time a day for 6 weeks. Individuals will be evaluated and exercise sessions will be conducted face to face. Exercise sessions will be performed under the control of a physiotherapist and each patient's heart rate, fatigue perception, dyspnea perception and saturation will be monitored. Individuals will be asked to report any negative experiences during or after the application. Exercises will be practiced before the application on the device. Before and after each exercise, heart rate, blood pressure, SpO2, dyspnea and fatigue values will be measured according to the Modified Borg Scale. They will be asked to be between 4-6 (moderate level) according to the scale during the exercise. At the end of the 2nd and 4th week, if dyspnea and fatigue do not develop in the person and the measured values are

Other: Whole Body Vibration

control group

ACTIVE COMPARATOR

Individuals will be informed about what they should do after bariatric surgery, what they should do during the treatment process and physical activity, they will be advised to walk regularly for 30 minutes a day, 7 days a week and they will be informed about the things to pay attention during walking. Patients in the control group will be asked to keep a diary, write down their vital signs and the extent to which they perform the exercise recommendation of 30 minutes a day, 7 days a week on a weekly basis. Patients in this group will be called regularly on a weekly basis and the information they keep in the diary will be requested and recorded.

Other: Control Group

Interventions

Resistance Training OTHER

The resistance exercise training group will be given resistance exercise with theraband for 6 weeks in addition to the conventional physiotherapy program. The exercise protocol will be performed 3 days a week, 1 time a day, 1 day supervised. The evaluation sessions of the individuals will be face to face. Sessions will start with a 5-minute warm-up exercise, resistance exercise protocol will be applied, and will end with a 5-minute cool-down exercise.

intervention group- resistance exercise

Whole Body Vibration OTHER

The WBV training group will be given exercises on the WBV device in addition to the conventional physiotherapy program. The exercise protocol will be performed face to face, 3 days a week, 1 time a day for 6 weeks. Individuals will be evaluated and exercise sessions will be conducted face to face. Exercise sessions will be performed under the control of a physiotherapist and each patient's heart rate, fatigue perception, dyspnea perception and saturation will be monitored. Individuals will be asked to report any negative experiences during or after the application.

intervention group- whole body vibration

Control Group OTHER

Individuals will be informed about what they should do after bariatric surgery, what they should do during the treatment process and physical activity, they will be advised to walk regularly for 30 minutes a day, 7 days a week and they will be informed about the things to pay attention during walking.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having undergone bariatric surgery, At least 6 weeks have passed since bariatric surgery, Being between the ages of 18-65, Being diagnosed with obesity and having a BMI\>35, There is no obstacle that restricts exercise

You may not qualify if:

• Acute hernia, Thromboembolism, Steroid use, Cardiovascular, neurological, orthopedic disease, Presence of knee or hip prosthesis, History of non-traumatic fracture, Presence of pacemaker, Malignancy, Presence of kidney, liver or thyroid disease, Presence of arrhythmia, Pregnancy status, Presence of kidney stones, Presence of epilepsy, Presence of migraine, Presence of organ failure, Presence of acute infection, History of smoking, Presence of respiratory system disease

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead
• Istinye University: collaborator

Related Publications (19)

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• https://www.researchgate.net/publication/367638746_THE_EFFECT_OF_6-WEEKS_WHOLE_BODY_VIBRATION_ON_MUSCULAR_PERFORMANCE_ON_YOUNG_NON-COMPETITIVE_FEMALE_ARTISTIC_GYMNASTS

  RESULT

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Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Overweight; Obesity, Morbid; Respiratory Aspiration

Interventions

Resistance Training; Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

büşra terim, PT, MSc

CONTACT

+90 5462131307; fztbusraterim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: May 22, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share