Effects of physical training on physical and functional fitness, physical activity level, endothelial function, hemodynamic variables, bone metabolism, and quality of life of post-bariatric patients: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2022-09, Vol.23 (1), p.733-733, Article 733
• Main Authors: Lopes, Karynne Grutter, das Graças Coelho de Souza, Maria, da Costa Tavares Bezerra, Michelle, Bessa, Lucas Miranda, Farinatti, Paulo, Bouskela, Eliete, Madeira, Miguel, Kraemer-Aguiar, Luiz Guilherme
• Format: Article
• Language: English
• Subjects: Bariatric surgery; Biomarkers; Bone health; Bones; Clinical trials; Data collection; Density; Evaluation; Exercise; Gastrointestinal surgery; Health aspects; Health promotion; Hemodynamics; Influence; Intervention; Isometric exercise; Laboratories; Metabolism; Mortality; Muscle mass; Muscle strength; Obesity; Physical fitness; Physiological aspects; Quality of life; Randomized controlled trials; Risk factors; Study Protocol; Surgery; Weight control
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06677-z

Background Evidence of the benefits induced from resistance exercise on health markers of post-bariatric patients is limited. The study will investigate the effects of a resistance training (RT) program on muscle mass and strength, bone metabolism biomarkers, bone mineral density (BMD), bone microarchitecture, and endothelial function of patients subjected to Roux-en-Y gastric bypass. Methods/design This randomized controlled trial will include 60 post-bariatric patients, physically inactive, aging 18 to 50 years, with a post-surgery period [greater than or equal to] 12 months. They will be randomly assigned into two groups: (i) the non-exercised control group, which will receive the standard clinical follow-up, or (ii) the intervention group which will consist of RT (60 min/session; 3 times/week, for 6 months). The primary outcomes will include muscle mass and strength, bone metabolism biomarkers, BMD, and bone microarchitecture. The secondary outcomes will be anthropometry, hemodynamic measurements, cardiovascular risk factors, health-related quality of life (QoL), and endothelial function. Outcomes will be assessed by blood biomarkers of bone formation and reabsorption, dual X-ray absorptiometry, repetition maximum and handgrip strength tests, high-resolution peripheral quantitative computed tomography, 36-Item Short-Form Health Survey, venous occlusion plethysmography, and nailfold videocapillaroscopy. Discussion It is expected that there are greater benefits from the RT program, possibly improving muscle mass and strength, bone metabolism, density and microarchitecture, QoL, and cardiovascular risk. Trial registration ClinicalTrials.gov NCT04193397. Registered on 7 December 2019. Keywords: Obesity, Bariatric surgery, Muscle mass, Muscle strength, Bone health, Randomized controlled trials