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

Bariatric Surgery Clinical Trial

— Obesity  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193397
• Other study ID #: BARexe
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Behavioral:
• Exercise training
Resistance training program performed during 6 months, 3 sessions per week

Locations

Country	Name	City	State
Brazil	Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University	Rio De Janeiro	Rio De Janeiro, Brazil

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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