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Not yet recruiting NCT07602959

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

No phase Interventional Obesity & Overweight Morbid Obesity Morbid Obesity Requiring Bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resistance Training, Whole Body Vibration, Control Group.
Who it may be relevant to
Registry conditions: Obesity & Overweight, Morbid Obesity, Morbid Obesity Requiring Bariatric Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Other Resistance Training
    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.
  • Other Whole Body Vibration
    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 as
  • Other Control Group
    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 outcome measures

  • Muscle Ultrasound [Time frame: 6 weeks]
  • Muscle Strength Measurement [Time frame: 6 weeks]
  • Elasticity Evaluation of Muscle [Time frame: 6 weeks]
  • Respiratory Muscle Strength Assessment [Time frame: 6 weeks]
  • Respiratory Muscle Endurance [Time frame: 6 weeks]
  • Pulmonary Function Test [Time frame: 6 weeks]
  • Cardiopulmonary Exercise Test [Time frame: 6 weeks]
  • Stiffness of Muscle [Time frame: 6 weeks]
  • Tonus Evaluation of Muscle [Time frame: 6 weeks]
Secondary outcome measures (3)
  • Biochemical Analyses [Time frame: 6 weeks]
  • Body Composition Analysis [Time frame: 6 weeks]
  • Assessment of Quality of Life [Time frame: 6 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Keller C, Steensberg A, Pilegaard H, Osada T, Saltin B, Pedersen BK, Neufer PD. Transcriptional activation of the IL-6 gene in human contracting skeletal muscle: influence of muscle glycogen content. FASEB J. 2001 Dec;15(14):2748-50. doi: 10.1096/fj.01-0507fje. Epub 2001 Oct 29. PMID 11687509
  • Necking LE, Lundstrom R, Lundborg G, Thornell LE, Friden J. Skeletal muscle changes after short term vibration. Scand J Plast Reconstr Surg Hand Surg. 1996 Jun;30(2):99-103. doi: 10.3109/02844319609056390. PMID 8815978
  • Roelants M, Delecluse C, Goris M, Verschueren S. Effects of 24 weeks of whole body vibration training on body composition and muscle strength in untrained females. Int J Sports Med. 2004 Jan;25(1):1-5. doi: 10.1055/s-2003-45238. PMID 14750005
  • Sheng B, Truong K, Spitler H, Zhang L, Tong X, Chen L. The Long-Term Effects of Bariatric Surgery on Type 2 Diabetes Remission, Microvascular and Macrovascular Complications, and Mortality: a Systematic Review and Meta-Analysis. Obes Surg. 2017 Oct;27(10):2724-2732. doi: 10.1007/s11695-017-2866-4. PMID 28801703
  • Vissers D, Verrijken A, Mertens I, Van Gils C, Van de Sompel A, Truijen S, Van Gaal L. Effect of long-term whole body vibration training on visceral adipose tissue: a preliminary report. Obes Facts. 2010;3(2):93-100. doi: 10.1159/000301785. Epub 2010 Apr 7. PMID 20484941
  • Zaki ME. Effects of whole body vibration and resistance training on bone mineral density and anthropometry in obese postmenopausal women. J Osteoporos. 2014;2014:702589. doi: 10.1155/2014/702589. Epub 2014 Jun 18. PMID 25136473
  • Huck CJ. Effects of supervised resistance training on fitness and functional strength in patients succeeding bariatric surgery. J Strength Cond Res. 2015 Mar;29(3):589-95. doi: 10.1519/JSC.0000000000000667. PMID 25226310
  • Hong SH, Choi KM. Sarcopenic Obesity, Insulin Resistance, and Their Implications in Cardiovascular and Metabolic Consequences. Int J Mol Sci. 2020 Jan 13;21(2):494. doi: 10.3390/ijms21020494. PMID 31941015

Identifiers

NCT: NCT07602959 · IstinyeU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗