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

R

Rio de Janeiro State University

Status

Completed

Conditions

Bariatric Surgery

Treatments

Behavioral: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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).

Enrollment

100 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Exercise training
Experimental group
Description:
Post-bariatric patients - Intervention group
Treatment:
Behavioral: Exercise training
No intervention
No Intervention group
Description:
Post-bariatric patients - Non-exercised control group

Trial contacts and locations

1

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Central trial contact

Luiz Guilherme K De Aguiar, PhD; Karynne G Lisboa Lopes dos Santos, PhD

Data sourced from clinicaltrials.gov

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