Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07602959

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

Sarcopenic obesity (SO) is the coexistence of obesity characterized by excess fat mass and sarcopenia and is a functional and clinical condition. Sarcopenia, defined as low mass and reduced function of skeletal muscle, has a multifactorial etiology and its prevalence increases with age The development of sarcopenia in obese individuals can occur at any age. Obesity can lead to both muscle mass and functional losses as it causes many conditions that negatively affect muscle mass such as inflammation, insulin resistance, oxidative stress, In addition, individuals with obesity have a high likelihood of non-communicable, chronic diseases that negatively affect muscle metabolism (catabolism and anabolism). Attempts to reduce high amounts of fat lead to losses in skeletal muscle mass. This is especially common after bariatric surgery and long-term unbalanced dietary regimens. However, fat accumulation in the abdominal and thoracic cavity and mediastinal area directly affects the mechanical properties of the lung and chest wall. Increased body fat deposition causes the diaphragm to remain in an upward position, thus limiting its downward movements, increasing pleural pressure, and decreasing functional residual capacity. However, fat accumulation in the abdominal and thoracic cavity and mediastinal area directly affects the mechanical properties of the lung and chest wall. Increased body fat deposition causes the diaphragm to remain in an upward position, thus limiting its downward movements, increasing pleural pressure and decreasing functional residual capacity. This reduction is 22% in obese people and 33% in severely obese people. The most important reason for the decrease in functional residual capacity in obese patients is the decrease in expiratory reserve volume. Expiratory residual volume decreases with increasing body mass index. Respiratory muscle weakness accompanies the picture due to both impaired length-tension relationship and decreased functional mobility of the diaphragm.

Bariatric surgery is a series of surgical methods for the treatment of morbid obesity. This procedure, which has recently gained popularity, is generally considered effective and safe. Bariatric surgery has significant health benefits, such as normalizing blood glucose levels, reducing hyperglycemia, lowering cholesterol and blood pressure, improving diabetes-related micro- and macrovascular complications and obstructive sleep apnea. However, like any other surgical procedure, this procedure has complications, some of which are life-threatening. However, like any other surgical procedure, this procedure has complications, some of which are life-threatening. Often after this surgery, people develop anemia and lose calcium and vitamins, which must be compensated by taking supplements for the rest of their lives. Some of the potentially serious complications of bariatric surgery include macro- and micronutrient deficiencies.

Bariatric surgery also has some adverse effects on the musculoskeletal system. In addition to low-calorie nutrition and surgery-induced malabsorption after surgery, it also causes weight loss through other mechanisms. Bariatric surgery alters the production of bile acids, pancreatic secretions and some hormones. There is an increase in the production of anorexigenic hormones and a decrease in the production of orexigenic hormones. Ghrelin is considered an orexigenic hormone as well as a growth hormone secretagogue and promotes muscle protein anabolism. After bariatric surgery, there is a significant increase in the level of cortisol, which promotes muscle protein catabolism. This is attributed to the hypocaloric diet and post-surgical stress. Bariatric surgery has been proven to reduce not only fat mass but also muscle mass and strength (16-40%). Therefore, implementing tailored exercise programs for people after bariatric surgery may help this population to increase weight loss while maintaining lean mass, bone mass and muscle strength in the long term.

Evidence for various exercise approaches is presented in the literature. With the addition of exercise to the weight loss induced by surgery, adaptations develop in muscle insulin sensitivity that will form the basis for recovery. Capillary density increased angiogenesis, angiogenesis and adaptations that increase insulin and glucose delivery to muscle. Exercise also improves mitochondrial function in skeletal muscle, metabolic flexibility, fat oxidation, and reduces lipotoxic species thought to underlie insulin resistance. Although the physiological mechanism of vibration application has not been clearly explained, it occurs with the activation of the tonic vibration reflex. With whole body vibration (TVV) or local vibration application, the change in muscle length is perceived, increasing the activation of the golgi tendon organ and muscle spindle, which are responsible for transmitting this change to the central nervous system. Ia afferent fibers that form the primary terminations of the muscle spindle, which is sensitive to changes in muscle length, activate the alpha motor neuron through monosynaptic connections, and tonic reflexive contractions occur. Increasing alpha motor neuron activation of the muscle spindle, which becomes more sensitive to tension with vibration application; It has been observed to increase the number of cross bridges established, the amount of motor units, motor unit synchronization, and firing frequency.. The application of vibration is also perceived by the ruffini corpuscles, paccini corpuscles, skin and joint receptors, golgi tendon organ. TVV application can increase the efficiency of the proprioceptive feedback loop. During isometric contractions, proprioceptive pathways are used to generate force. A more efficient proprioceptive feedback loop caused by vibration application may lead to increases in force production. The proposed mechanisms for improvements in body composition (decrease in fat mass, increase in muscle mass) caused by TVV are the same as the proposed mechanisms for improvements after resistance exercise. The additional gravitational loading experienced by individuals when exposed to TVV has been shown to elicit an anabolic response. This is comparable to studies using resistance exercise. Both TVV application and resistance training cause an increase in testosterone and growth hormone levels. Studies have shown that repetitive muscle contractions and changes in the hormonal system caused by vibration application elicit some metabolic responses. This application increases the oxygen uptake of tissues and blood flow of skin and subcutaneous tissues. A decrease in arterial stiffness was observed after application. It also stimulates lipolysis by increasing lipolytic hormones.

The literature on TVV application shows that it significantly improves muscle strength and physical activity of participants performing unloaded exercise . It has also been found to be effective in alleviating conditions such as decreased muscle mass, muscle strength, and bone density, and has similar benefits to resistance training, especially in terms of increasing muscle performance ). Resistance exercises alone or in combination with aerobic exercises prevent the loss of muscle strength associated with bariatric surgery). In particular, resistance training has been shown to increase muscle strength and reduce muscle atrophy in obese individuals who adhere to calorie restriction for weight loss. In a study involving 12 weeks of resistance exercises with 19 participants, a decrease in body weight and waist circumference was observed. There was a significant increase in hand grip strength. Significant improvements were observed in lower and upper extremity muscle strength. People's moderate-to-vigorous physical activity levels increased significantly.

People who have undergone bariatric surgery are recommended to exercise, but the recommended guidelines are not specific to people who have undergone surgery. The American College of Sports Medicine recommends the same amount of physical activity for both individuals who have undergone bariatric surgery and those with obesity. Initiation of exercise interventions after bariatric surgery ranges from 1 to 3 months, depending on the type of exercise. It is observed that resistance exercises are started at the 6th week after surThe aim of this study was to demonstrate the feasibility of whole body vibration application after bariatric surgery.gery and the duration is prolonged in different studies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Muscle Ultrasound

    Time frame: 6 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-sarcopenic elderly (Li et al., 2020).

  2. Muscle Strength Measurement

    Time frame: 6 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).

  3. Elasticity Evaluation of Muscle

    Time frame: 6 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).

  4. Respiratory Muscle Strength Assessment

    Time frame: 6 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 will be expressed as a percentage of normal reference values calculated according to age and gender.

  5. Respiratory Muscle Endurance

    Time frame: 6 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., 2018).

  6. Pulmonary Function Test

    Time frame: 6 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).

  7. Cardiopulmonary Exercise Test

    Time frame: 6 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 will be recorded.

  8. Stiffness of Muscle

    Time frame: 6 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

  9. Tonus Evaluation of Muscle

    Time frame: 6 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. 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

Secondary outcomes

  1. Biochemical Analyses

    Time frame: 6 weeks

    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.

  2. Body Composition Analysis

    Time frame: 6 weeks

    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.

  3. Assessment of Quality of Life

    Time frame: 6 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

büşra terim, PT, MSc

CONTACT

[email protected]

+90 5462131307

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Collaborators

  • Istinye University

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.