Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty

NCT07868562 | Not Yet Recruiting

• 2 other identifiers: 0197112640000520801971126.4.0000.5208
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to compare parameters of diaphragmatic mechanics, respiratory muscle function, and thoracoabdominal kinematics among women with gastroesophageal reflux disease (GERD) and a history of abdominoplasty, women with a history of abdominoplasty alone, and women with GERD alone, seeking to understand whether the association between these conditions is linked to greater impairment of respiratory function and thoracoabdominal dynamics. The main question the study aims to answer is: Do women with GERD and a history of abdominoplasty exhibit greater impairment of diaphragmatic mechanics compared to those with a history of abdominoplasty alone and those with GERD alone? Researchers will compare three groups of participants: women with GERD and a history of abdominoplasty, women with a history of abdominoplasty alone, and women with GERD alone to determine whether the coexistence of GERD and abdominoplasty is associated with greater alterations in diaphragmatic mobility and thickness, respiratory muscle strength and endurance, thoracoabdominal kinematics, abdominal core and sternocleidomastoid muscle thickness, and body composition, as well as worse GERD-related symptoms and quality of life. Participants will undergo an initial clinical assessment, including medical history, anthropometric measurements, and body composition analysis via bioimpedance. They will also complete questionnaires regarding GERD symptoms, quality of life, and physical activity levels. Subsequently, assessments will be performed, including ultrasound of the diaphragm, abdominal muscles, and sternocleidomastoid muscle; spirometry; evaluation of thoracoabdominal kinematics; measurement of respiratory muscle strength via manovacuometry; and a respiratory muscle endurance test. When necessary for the diagnostic confirmation of GERD, 24-hour ambulatory esophageal impedance-pH monitoring will be performed. Upon completion of the assessments, the results obtained will be compared across the three groups to identify potential differences related to the association between GERD and abdominoplasty.

Conditions

Abdominoplasty; Diaphragm; Respiratory Mechanics; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (3)

• Diaphragmatic mobility

  1 day

• Diaphragmatic Thickness

  1 day

• Diaphragmatic contraction velocity

  1 day

Secondary Outcomes (43)

• Diaphragmatic Thickening Fraction (DTF)

  1 day

• Forced expiratory volume in the first second (FEV1)

  1

• Forced vital capacity (FVC)

  1 day

• FEV1/FVC ratio

  1 day

• Physical activity level

  1 day

Study Arms (3)

DRGE + AP Group

Individuals with a diagnosis of GERD confirmed by 24-hour impedance-pH monitoring and a history of abdominoplasty at least 10 years ago.

Other: Assessment of anthropometric and sociodemographic data and clinical history; Other: Assessment of Symptoms, Quality of Life, and Physical Activity; Other: Spirometric assessment; Other: Manovacuometry assessment; Other: Ultrasound Assessment of the Diaphragm, Abdominal Core, and Sternocleidomastoid; Other: Assessment of respiratory muscle endurance; Other: Thoracoabdominal kinematics; Other: Body bioimpedance assessment

DRGE Group

Individuals with a diagnosis of GERD confirmed by 24-hour impedance-pH monitoring, without a history of abdominoplasty.

Other: Assessment of anthropometric and sociodemographic data and clinical history; Other: Assessment of Symptoms, Quality of Life, and Physical Activity; Other: Spirometric assessment; Other: Manovacuometry assessment; Other: Ultrasound Assessment of the Diaphragm, Abdominal Core, and Sternocleidomastoid; Other: Assessment of respiratory muscle endurance; Other: Thoracoabdominal kinematics; Other: Body bioimpedance assessment

AP Group

Individuals with a history of abdominoplasty at least 10 years ago, without suggestive symptoms and with no diagnosis of GERD.

Other: Assessment of anthropometric and sociodemographic data and clinical history; Other: Assessment of Symptoms, Quality of Life, and Physical Activity; Other: Spirometric assessment; Other: Manovacuometry assessment; Other: Ultrasound Assessment of the Diaphragm, Abdominal Core, and Sternocleidomastoid; Other: Assessment of respiratory muscle endurance; Other: Thoracoabdominal kinematics; Other: Body bioimpedance assessment

Interventions

Assessment of anthropometric and sociodemographic data and clinical history OTHER

The initial assessment will be conducted using a standardized form developed by the researchers, covering sociodemographic data (age, sex, ethnicity, education level, occupation), anthropometric data (weight, height, body mass index, waist circumference), a clinical history of symptoms (onset, weekly frequency, time of peak occurrence, triggering factors, use of antacids, psychosocial factors, alarm symptoms, presence of comorbidities, smoking, alcohol consumption, and history of thoracoabdominal surgeries), and a physical examination.

AP Group; DRGE + AP Group; DRGE Group

Assessment of Symptoms, Quality of Life, and Physical Activity OTHER

GERD-related symptoms will be assessed using the Gastroesophageal Reflux Disease Symptom Questionnaire (QS-DRGE), which has been validated for the Portuguese language. Disease-related quality of life will be assessed using the GERD-HRQL questionnaire (Appendix B), translated into Portuguese. Physical activity levels will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ), validated for the Portuguese language. Both instruments will be administered individually by a previously trained researcher in a private setting during the initial assessment. Participants will complete the questionnaires via a structured interview, with any questions clarified without influencing the responses.

AP Group; DRGE + AP Group; DRGE Group

Spirometric assessment OTHER

Pulmonary function will be assessed via spirometry using a Micro Medical MicroLoop MK8 spirometer (England), calibrated daily with a 3-liter syringe in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) recommendations. The following parameters will be measured: slow vital capacity (SVC), inspiratory capacity (IC), forced vital capacity (FVC), forced expiratory volume in the first second (FEV₁), FEV₁/FVC ratio, and peak expiratory flow (PEF). Tests will be conducted in a suitable environment by a trained evaluator, with participants seated and wearing a nose clip, following instructions and a prior demonstration of the maneuvers. At least three acceptable and reproducible forced expiratory maneuvers will be performed, and the best values obtained will be used. Interpretation will be based on reference equations for the Brazilian population, with biosafety measures implemented throughout the procedure.

AP Group; DRGE + AP Group; DRGE Group

Manovacuometry assessment OTHER

Respiratory muscle strength will be assessed via manovacuometry using the MVD 300 U HOMED device, in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) recommendations. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured. Participants will remain seated without back support, with the trunk upright, head in a neutral position, and feet resting on the floor, while using a nose clip and a mouthpiece with an adequate seal. MIP will be obtained following maximal expiration to residual volume, followed by maximal inspiration against an occluded airway, whereas MEP will be measured following maximal inspiration to total lung capacity, followed by forced expiration against the occluded mouthpiece. Three to five acceptable and reproducible maneuvers will be performed, and the highest value obtained will be recorded. Interpretation will be based on reference equations for the Brazilian population.

AP Group; DRGE + AP Group; DRGE Group

Ultrasound Assessment of the Diaphragm, Abdominal Core, and Sternocleidomastoid OTHER

Diaphragmatic mechanics and the thickness of the abdominal core muscles and sternocleidomastoid will be assessed via ultrasound using a LOGIQ-V2 (General Electric) system. Participants will be positioned in a semi-reclined supine position (30°-45°). A convex transducer (3.5 MHz) will be used to measure diaphragmatic mobility in M-mode, while a linear transducer (7 MHz) will be used to assess diaphragmatic thickness, the thickening fraction, and the thickness of the rectus abdominis, internal and external obliques, transversus abdominis, and sternocleidomastoid muscles in B-mode. Mobility will be recorded during quiet breathing and deep inspiration, whereas muscle thickness will be measured at the end of expiration and at maximal inspiration. At least three consecutive measurements will be performed for each variable, and the mean value will be used. All procedures will follow previously validated protocols and standardized verbal commands to ensure measurement reproducibility.

AP Group; DRGE + AP Group; DRGE Group

Assessment of respiratory muscle endurance OTHER

Inspiratory muscle endurance will be assessed using the POWERbreathe® KH2 (Powerbreathe International Ltd.) with a load set at 60% of the maximal inspiratory pressure (MIP) previously determined via manovacuometry. The test will be conducted in a controlled environment using calibrated equipment and administered by a trained evaluator, following instructions and a demonstration of the technique. Participants will remain seated with their trunks upright, heads in a neutral position, and feet resting on the floor, while using a nose clip and a mouthpiece with a proper seal. Cycles of rapid, vigorous inspiration against resistance,followed by passive expiration,will be performed for up to 10 minutes or until the limit of tolerance is reached. Heart rate and peripheral oxygen saturation will be measured before and after the test. The device will automatically record inspiratory power, energy, inspiratory volume and flow, endurance time, S-Index, peak inspiratory flow, and the number of bre

AP Group; DRGE + AP Group; DRGE Group

Thoracoabdominal kinematics OTHER

Thoracoabdominal kinematics will be assessed using optoelectronic plethysmography (OEP BTS Bioengineering®, Milan, Italy) in a room equipped with a system of pre-calibrated, synchronized infrared cameras. Participants will remain seated with an upright trunk and the head in a neutral position, while 89 reflective markers are attached to standardized anatomical landmarks on the chest and abdominal walls. The system will perform a three-dimensional reconstruction of the thoracoabdominal surface and calculate respiratory volumes via mathematical integration. During data acquisition, participants will breathe quietly for 3 minutes. The following parameters will be analyzed: total chest wall volume (Vcw); the volumes of the pulmonary rib cage (Vrc,p), abdominal rib cage (Vrc,a), and abdominal (VAb) compartments; their relative contributions to tidal volume (%Rc and %Ab); and the absolute change in abdominal volume (ΔVAb).

AP Group; DRGE + AP Group; DRGE Group

Body bioimpedance assessment OTHER

Body composition will be assessed via multifrequency electrical bioimpedance using the InBody 120® to characterize the sample and control for confounding factors. Participants will be instructed to fast for at least four hours; avoid alcohol for the preceding 48 hours; avoid intense physical activity, caffeine, and thermogenic supplements for the preceding 24 hours; maintain their usual hydration; empty their bladder before the test; remove metal objects; and wear light clothing. Assessments will follow the manufacturer's recommendations, with the participant standing barefoot, maintaining proper contact with the electrodes, and resting for five minutes beforehand. Tests involving movement or loss of contact will be repeated. The following variables will be obtained: body fat index, skeletal muscle mass, fat-free mass index, total fat mass, total and segmental body fat percentage, segmental lean mass, waist-to-hip ratio, total body water, and estimated ideal weight.

AP Group; DRGE + AP Group; DRGE Group

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult women, with and without a diagnosis of GERD and with and without a history of abdominoplasty. After confirmation of eligibility criteria, participants will be assigned to three study groups based on their clinical and surgical characteristics: GERD + abdominoplasty group (GERD+AP), GERD group (GERD), and abdominoplasty group (AP).

You may qualify if:

• Female individuals aged ≥ 60 years with a body mass index (BMI) ≥ 30 kg/m² who meet the following criteria, according to the allocation group, will be included:
• GERD + AP Group: individuals with a diagnosis of GERD confirmed by 24-hour impedance-pH monitoring and a history of abdominoplasty at least 10 years prior.
• GERD Group: individuals with a diagnosis of GERD confirmed by 24-hour impedance-pH monitoring, without a history of abdominoplasty.
• AP Group: individuals with a history of abdominoplasty at least 10 years prior, without symptoms suggestive of GERD and with no diagnosis of GERD.

You may not qualify if:

• Participants will be excluded if they have a hiatal hernia larger than 3 cm; chronic respiratory diseases capable of interfering with ventilatory mechanics (such as Chronic Obstructive Pulmonary Disease - COPD, Interstitial Lung Diseases - ILD, or severe asthma); a history of other thoracoabdominal surgeries; neuromuscular diseases; acute respiratory diseases within the last 30 days; an inability to perform the proposed tests; or if they are pregnant.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Departamento de Fisioterapia - UNIVERSIDADE FEDERAL DE PERNAMBUCO (UFPE)

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Quality of Life; Exercise

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

BR (1)