About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Resistance Training
Other interventionThe 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 interventionThe 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 interventionIndividuals 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
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.
Secondary outcomes
Biochemical Analyses
Blood will be collected in gel biochemistry tubes in Istinye University laboratories before and after 6 weeks of exercise training and serum samples will be obtained after centrifugation for 10 minutes. Serum samples will be kept frozen at -80 degrees Celsius until the day of the experiment. The concentrations of TNF-alpha, interleukin 6, interleukin 4, interleukin 12, CK-MM, CK-MB parameters in serum samples will be measured by commercially available ELISA-based kits.
Body Composition Analysis
Participants' body weights, body fat percentages and torso summer percentages will be measured with Tanita-BC 418 device. Situations that may affect the measurement will be specified and people will come to the measurement by following the instructions. Before the application, people are asked to stand on the device platform by selecting their age, height and body type.
Assessment of Quality of Life
The Impact of Weight on Quality of Life (IWQOL) scale was developed by Kolotkin in 1995. In 2001, the short version of the scale, IWQOL-Lite, was created. The short form of the scale consists of 5 groups and 31 items: self-confidence (7 items), bodily functions (11 items), work (4 items), sexual life (4 items), social pressure (5 items). A maximum score of 100 and a minimum score of 0 is obtained from the scale. A high score indicates a high quality of life and a low score indicates a low quality of life. Çömlekçi et al. The questionnaire, whose Turkish validity and reliability was performed by Çömlekçi et al. consists of 29 items. Work 3 and Work 4 items were removed (Necmiye, 2010). In our study, this test will be used to measure the quality of life of individuals
Locations
Sponsors and contacts
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Kirsehir Ahi Evran Universitesi
Lead sponsor
Istinye University
Collaborator
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