Clinical Trials Logo

Clinical Trial Summary

The purpose of this clinical trial is to study the effects of resistance training program on physical-functional fitness, muscle mass and strength, endothelial function, blood pressure, biochemical markers of cardiovascular risk and bone metabolism, density and microstructure and quality of life of post-bariatric patients (Study 1). To compare the bone and muscle changes in post-bariatric patients by Roux-en-Y Gastric Bypass Surgery with non-bariatric controls, as well as to correlate these health indicators with surgery time and weight loss (Study 2).


Clinical Trial Description

Randomized controlled trial (Study 1) will feature post-bariatric patients in outpatient care at the public health unit. The post-bariatric patients will be randomized through a random code generator software (www.randomization.com) at a ratio of 1:1, into two groups: a) Intervention group - that will perform a supervised RT program for 6-months or b) Non-exercised control group - that will receive the standard clinical follow-up and shall not change their physical activity behavior. The exercise sessions will include: a) 10-min specific warm-up, consisting of one set of 20 repetitions with loads corresponding to 50% of the resistance used in the first exercise of the training session; b) 45-min of resistance exercises for the upper and lower body (8 single and multi-joint exercises with free weights and machines, including seated rowing, leg press, bench press, leg flexion, pull down, leg extension, shoulder press, and abdominal exercises), performed with 2-3 sets of 8 to 12 repetitions with loads ≥ 70% of one-repetition maximum (1RM) interspersed with 2 min intervals between sets; c) 5-min recovery with stretch and cool-down exercises. During six months, all training sessions will occur three times a week on nonconsecutive days. The outcomes will be assessed by dual energy X-ray emission densitometry (DXA); high resolution peripheral quantitative computed tomography (HR-pQCT), repetition maximum, handgrip strength; biochemical analysis (blood lipid profile, blood glucose and biomarkers of bone formation and absorption and calcium metabolism); venous occlusion plethysmography and nailfold videocapillaroscopy; blood pressure measurement and 36-Item Short-form Health Survey. The cross-sectional study (Study 2) will have 2 groups: post-bariatric patients group (BG) and control group (CG) - non-bariatric controls. Outcomes will be assessed by DXA; HR-pQCT; handgrip strength and biochemical analysis (blood lipid profile, blood glucose and biomarkers of bone formation and absorption and calcium metabolism). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04193397
Study type Interventional
Source Rio de Janeiro State University
Contact
Status Completed
Phase N/A
Start date December 1, 2022
Completion date March 31, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04433338 - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery N/A
Completed NCT05854875 - Diabetes Remission After RYGBP and RYGBP With Fundus Resection N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Enrolling by invitation NCT02552433 - Complications in Body Contouring Surgery
Completed NCT02525016 - Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery Phase 3
Recruiting NCT01984762 - Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. N/A
Not yet recruiting NCT01652105 - Randomized Trial of Preoperative Diets Before Bariatric Surgery N/A
Completed NCT00989157 - Effects of Gastric Bypass on Blood Levels of Duloxetine Phase 3
Completed NCT03609632 - Understanding Hypoglycaemia After Bariatric Surgery N/A
Completed NCT05454696 - Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery N/A
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Recruiting NCT04297306 - Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery N/A
Recruiting NCT05428618 - Mobile Application for Bariatric Surgery Patients N/A
Not yet recruiting NCT03975244 - Semi-supervised Exercise Program Before Bariatric Surgery N/A
Not yet recruiting NCT03900481 - Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity N/A
Recruiting NCT06170749 - Prediction Model for Anemia After Bariatric Surgery