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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04193397
Other study ID # BARexe
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date March 31, 2024

Study information

Verified date April 2024
Source Rio de Janeiro State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Patients subjected to Roux-en-Y gastric bypass - Aging 18 to 50-years - At least 12 months from surgery Exclusion criteria: - Smoking - Alcoholism - Gestation - Cardiovascular disease - Respiratory disease - Neurological disease - Infectious disease - Endocrine disease - Musculoskeletal impairments - Use of hormonal replacement therapy that influence bone metabolism - Use of medications that influence bone metabolism - Start some physical exercise program during the study - Excess weight loss <50% - Use drugs that interfere with weight - Revisional bariatric surgery - Regular physical exercise

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise training
Resistance training program performed during 6 months, 3 sessions per week

Locations

Country Name City State
Brazil Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University Rio De Janeiro Rio De Janeiro, Brazil

Sponsors (1)

Lead Sponsor Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline body composition at 6 months Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry Baseline and 6 months of follow-up
Primary Changes from baseline bone microarchitecture at 6 months Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography Baseline and 6 months of follow-up
Primary Changes from baseline muscle strength at 6 months Muscle strength will be evaluated by one repetition maximum test and handgrip strength Baseline and 6 months of follow-up
Primary Changes from baseline blood biomarkers at 6 months Bone formation and reabsorption biomarkers will be evaluated by blood sample collection Baseline and 6 months of follow-up
Primary Changes from baseline blood biomarkers at 6 months Metabolic profile will be evaluated by blood sample collection Baseline and 6 months of follow-up
Secondary Changes from baseline quality of life indicators at 6 months Quality of life indicators will be evaluated by 36-Item Short-form Health Survey Baseline and 6 months of follow-up
Secondary Changes from baseline cardiovascular risk factors at 6 months Cardiovascular risk factors will be evaluated by body mass index, waist circumference, blood pressure, triglycerides, HDL-c, LDL-c, total cholesterol, and fasting glycemia Baseline and 6 months of follow-up
Secondary Changes from baseline anthropometric markers at 6 months Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer Baseline and 6 months of follow-up
Secondary Changes from baseline hemodynamic measurement at 6 months Blood pressure and heart rate will be assessed by a digital sphygmomanometer Baseline and 6 months of follow-up
Secondary Changes from baseline endothelial function at 6 months Endothelial function will be evaluated by venous occlusion plethysmography and periungual videocapilaroscopy Baseline and 6 months of follow-up
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