Effects of Physical Training on Health Markers of Post-bariatric Patients (Obesity)

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: a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Behavioral: Exercise training

Detailed 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil
    • Rio De Janeiro, Rio De Janeiro, Brazil, Brazil, 20550013
      • Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training; Post-bariatric patients - Intervention group	Behavioral: Exercise training; Resistance training program performed during 6 months, 3 sessions per week
No Intervention: No intervention; Post-bariatric patients - Non-exercised control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Investigators: Principal Investigator: Luiz Guilherme K De Aguiar, PhD, Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil

Publications and helpful links

General Publications

• Lopes KG, das Gracas Coelho de Souza M, da Costa Tavares Bezerra M, Bessa LM, Farinatti P, Bouskela E, Madeira M, Kraemer-Aguiar LG. 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. Trials. 2022 Sep 2;23(1):733. doi: 10.1186/s13063-022-06677-z.
• Lopes KG, Romagna EC, da Silva DS, da Costa Tavares Bezerra M, Leal PRF, da Silva Soares Pinto JE, Bouskela E, das Gracas Coelho de Souza M, Kraemer-Aguiar LG. Metabolic and Inflammatory Profiles of Post-Bariatric Patients with Weight Recidivism. Obes Surg. 2022 Jun;32(6):1849-1855. doi: 10.1007/s11695-022-06025-9. Epub 2022 Mar 23.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 7, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Muscle strength; Muscle mass; Bone mineral density; Bone microarchitecture
• Other Study ID Numbers: BARexe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No