Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT07602959

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity & Overweight, Morbid Obesity, Morbid Obesity Requiring Bariatric Surgery

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

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.

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.

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.

Primary outcomes

Muscle Ultrasound6 weeks

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-sa…

Muscle Strength Measurement6 weeks

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).

Elasticity Evaluation of Muscle6 weeks

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).

Respiratory Muscle Strength Assessment6 weeks

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…

Respiratory Muscle Endurance6 weeks

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…

Pulmonary Function Test6 weeks

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).

Cardiopulmonary Exercise Test6 weeks

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…

Stiffness of Muscle6 weeks

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

Study locations

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