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Completed

NCT Number: NCT04193397

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

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).

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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

Primary outcomes

  1. Changes from baseline body composition at 6 months

    Time frame: Baseline and 6 months of follow-up

    Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry

  2. Changes from baseline bone microarchitecture at 6 months

    Time frame: Baseline and 6 months of follow-up

    Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography

  3. Changes from baseline muscle strength at 6 months

    Time frame: Baseline and 6 months of follow-up

    Muscle strength will be evaluated by one repetition maximum test and handgrip strength

  4. Changes from baseline blood biomarkers at 6 months

    Time frame: Baseline and 6 months of follow-up

    Bone formation and reabsorption biomarkers will be evaluated by blood sample collection

  5. Changes from baseline blood biomarkers at 6 months

    Time frame: Baseline and 6 months of follow-up

    Metabolic profile will be evaluated by blood sample collection

Secondary outcomes

  1. Changes from baseline quality of life indicators at 6 months

    Time frame: Baseline and 6 months of follow-up

    Quality of life indicators will be evaluated by 36-Item Short-form Health Survey

  2. Changes from baseline cardiovascular risk factors at 6 months

    Time frame: Baseline and 6 months of follow-up

    Cardiovascular risk factors will be evaluated by body mass index, waist circumference, blood pressure, triglycerides, HDL-c, LDL-c, total cholesterol, and fasting glycemia

  3. Changes from baseline anthropometric markers at 6 months

    Time frame: Baseline and 6 months of follow-up

    Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer

  4. Changes from baseline hemodynamic measurement at 6 months

    Time frame: Baseline and 6 months of follow-up

    Blood pressure and heart rate will be assessed by a digital sphygmomanometer

  5. Changes from baseline endothelial function at 6 months

    Time frame: Baseline and 6 months of follow-up

    Endothelial function will be evaluated by venous occlusion plethysmography and periungual videocapilaroscopy

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

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

Acronym: Obesity

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 10, 2019
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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