Effects of Physical Training on Health Markers of Post-bariatric Patients

NCT04193397 | Completed

• 1 other identifier: BARexe
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bariatric Surgery

Keywords

Obesity; Muscle mass; Muscle strength; Bone mineral density; Bone microarchitecture

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Changes from baseline quality of life indicators at 6 months

  Baseline and 6 months of follow-up

• Changes from baseline cardiovascular risk factors at 6 months

  Baseline and 6 months of follow-up

• Changes from baseline anthropometric markers at 6 months

  Baseline and 6 months of follow-up

• Changes from baseline hemodynamic measurement at 6 months

  Baseline and 6 months of follow-up

• Changes from baseline endothelial function at 6 months

  Baseline and 6 months of follow-up

Study Arms (2)

Exercise training

EXPERIMENTAL

Post-bariatric patients - Intervention group

Behavioral: Exercise training

No intervention

NO INTERVENTION

Post-bariatric patients - Non-exercised control group

Interventions

Exercise training BEHAVIORAL

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

Exercise training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients subjected to Roux-en-Y gastric bypass
• Aging 18 to 50-years
• At least 12 months from surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil, 20550013, Brazil

Location

Related Publications (2)

• 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.

  PMID: 36056396 DERIVED

• 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.

  PMID: 35320489 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luiz Guilherme K De Aguiar, PhD

  Rio de Janeiro State University, Rio de Janeiro, RJ, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention group will perform a supervised resistance training program, while non-exercised control group will receive the standard clinical follow-up and shall not change their physical activity behavior (Study 1) and Post-bariatric group or non-bariatric control group (Study 2)

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)