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Bariatric SurgeryObesityNCT04193397

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

A study testing Exercise training in people with Bariatric Surgery, run by Rio de Janeiro State University at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Bariatric Surgery
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBrazil
Study dates
1 Dec 2022to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Smoking
  • Alcoholism
  • Gestation
  • Cardiovascular disease
  • Respiratory disease
  • Neurological disease
Show all 16Show fewer
  • 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 locations and contacts

1 site in 1 country.

Brazil1 site

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

    Rio de Janeiro, Rio de Janeiro, Brazil, 20550013

Other trials in Brazil

About this study

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

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).

Read the 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).

Being tested
Exercise training
Keywords
Obesity, Muscle mass, Muscle strength, Bone mineral density, Bone microarchitecture
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise trainingBehavioural

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

Study groups in NCT04193397
Study groupRoleWhat they receive
Exercise trainingExperimentalPost-bariatric patients - Intervention group
Receives: Behavioral: Exercise training
No interventionNo interventionPost-bariatric patients - Non-exercised control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline body composition at 6 months

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

    Measured: Baseline and 6 months of follow-up

  2. Changes from baseline bone microarchitecture at 6 months

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

    Measured: Baseline and 6 months of follow-up

  3. Changes from baseline muscle strength at 6 months

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

    Measured: Baseline and 6 months of follow-up

  4. Changes from baseline blood biomarkers at 6 months

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

    Measured: Baseline and 6 months of follow-up

  5. Changes from baseline blood biomarkers at 6 months

    Metabolic profile will be evaluated by blood sample collection

    Measured: Baseline and 6 months of follow-up

Secondary outcomes (5)

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

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

    Measured: Baseline and 6 months of follow-up

  2. 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

    Measured: Baseline and 6 months of follow-up

  3. Changes from baseline anthropometric markers at 6 months

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

    Measured: Baseline and 6 months of follow-up

  4. Changes from baseline hemodynamic measurement at 6 months

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

    Measured: Baseline and 6 months of follow-up

  5. Changes from baseline endothelial function at 6 months

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

    Measured: Baseline and 6 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start1 Dec 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193397
Sponsor's protocol ID
BARexe
Acronym
Obesity
Status last verified
Apr 2024
First submitted
4 Dec 2019
Last updated
16 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Almeida CM, Lopes KG, da Costa Tavares Bezerra M, Leal PRF, Bouskela E, da Gama EMF, de Farias MLF, Madeira M, Kraemer-Aguiar LG. Bone Health After Metabolic and Bariatric Surgery: Osteometabolism Biomarkers, Bone Mineral Density, and Microarchitecture. Obesity (Silver Spring). 2026 Mar;34(3):598-607. doi: 10.1002/oby.70132. Epub 2026 Feb 17.

    PubMed 41703971

  • 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.

    PubMed 36056396

  • 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.

    PubMed 35320489

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Bariatric Surgery, run by Rio de Janeiro State University at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline body composition at 6 months (time frame: Baseline and 6 months of follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04193397, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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