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

NCT ID: NCT04193397

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-03-31

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).

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).

Conditions

Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise training

Post-bariatric patients - Intervention group

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

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

No intervention

Post-bariatric patients - Non-exercised control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luiz Guilherme K De Aguiar, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Rio de Janeiro, Rio de Janeiro, Brazil, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 36056396 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35320489 (View on PubMed)

Other Identifiers

BARexe

Identifier Type: -

Identifier Source: org_study_id