Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

NCT07289958 | Recruiting

• 1 other identifier: 2025-IMTObes
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a health condition caused by excessive accumulation of body fat. This condition is linked to the development of chronic diseases and also places increased stress on the respiratory system, leading to respiratory disorders, exacerbation of preexisting respiratory conditions, and a decline in physical capacity and exercise tolerance. Respiratory muscle training has been shown to have beneficial effects on respiratory function in these patients, although the effects this strategy has on other metabolic and physiological aspects related to exercise and obesity that are affected remain unclear.

Conditions

Bariatric Surgery

Keywords

Bariatric Surgery; Inspiratory muscle training; Therapeutic exercise

Outcome Measures

Primary Outcomes (4)

• Maximum inspiratory pressure (MIP)

  Maximum inspiratory pressure (MIP) is the maximum level of pressure applied to the lungs during inhalation. In normal breathing, this value reflects a negative pressure in centimeters of water (cm H₂O).

  Before and after intervention (12 weeks)

• Sleep Apnea

  Sleep apnea is a potentially serious sleep disorder in which breathing stops and starts repeatedly. They are measured with sleep tests that measure heart rate, oxygen levels, airflow, and breathing patterns. The Apnea-Hypopnea Index (AHI) is a measure of the number of times a person stops breathing (apnea) or has shallow breathing (hypopnea) per hour of sleep. A higher AHI indicates greater severity, with typical ranges classifying the condition as mild (5-15 events/hour), moderate (16-30 events/hour), or severe (more than 30 events/hour).

  Before and after intervention (12 weeks)

• 1-minute Sit-to-Stand test

  Number of sit-to- stand repetitions done in 1 minute (STS-1m). A 46-cm high chair will be used.

  Before and after intervention (12 weeks)

• Walking distance

  The six-minute walking test (6MWT) will be used to determine walking distance, in meters (m), covered during six minutes. A 20-meter indoor corridor will be used and patients will be encouraged to walk as much as possible during that time.

  Before and after intervention (12 weeks)

Secondary Outcomes (12)

• Sleep quality

  Before and after intervention (12 weeks)

• Resting heart rate

  Before and after intervention (12 weeks)

• Blood pressure

  Before and after intervention (12 weeks)

• Glycosylated hemoglobin

  Before and after intervention (12 weeks)

• Lipid Profile

  Before and after intervention (12 weeks)

Study Arms (4)

Control Group

SHAM COMPARATOR

The control group will perform inspiratory muscle training with a simulated device 5 times a week for 12 weeks and usual care.

Other: simulated inspiratory muscle

Inspiratory muscle training

EXPERIMENTAL

Inspiratory muscle training with intensities of 30% to 60% of maximum inspiratory performing 30 repetitions 5 times a week for 12 weeks and usual care.

Behavioral: Inspiratory muscle training

Institutionalized therapeutic exercise + simulated inspiratory muscle training

EXPERIMENTAL

Aerobic training with intensities of 50 to 65% of the Reserve Heart Rate, neuromuscular training with intensities of 40 to 70% of 1RM and Inspiratory muscle training with simulated inspiratory muscle training, 5 times a week for 12 weeks.

Behavioral: Inspiratory muscle training; Other: simulated inspiratory muscle

Institutionalized therapeutic exercise + inspiratory muscle training

EXPERIMENTAL

Aerobic training with intensities of 50 to 65% of the Reserve Heart Rate, neuromuscular training with intensities of 40 to 70% of 1RM and Inspiratory muscle training with intensities of 30% to 60% of maximum inspiratory pressure performing 30 repetitions, 5 times a week for 12 weeks.

Behavioral: Institutionalized therapeutic exercise; Behavioral: Inspiratory muscle training

Interventions

Institutionalized therapeutic exercise BEHAVIORAL

Physical exercise program for cardiometabolic rehabilitation (institutionalized) with aerobic training starting with intensities of 50% to 54% of Heart Rate Reserve from week 1 to 4, increasing from 54% to 60% from week 5 to 8 and from 60% to 65% from week 9 to 12, with volumes of 10 minutes the first week and 20 minutes from week 2 to 12, neuromuscular training with intensities of 40% to 70% of 1RM estimated by OMNI RES scale with volumes of 10 to 15 repetitions 3 to 4 sets, 3 times per week.

Institutionalized therapeutic exercise + inspiratory muscle training

Inspiratory muscle training BEHAVIORAL

Inspiratory muscle training using a pressure threshold system exerciser with an initial intensity of 30% of maximum inspiratory pressure, increasing the pressure by 10% every 2 weeks until reaching 60% with a volume of 3 sets of 10 repetitions, 5 times per week for 12 weeks.

Inspiratory muscle training; Institutionalized therapeutic exercise + inspiratory muscle training; Institutionalized therapeutic exercise + simulated inspiratory muscle training

simulated inspiratory muscle OTHER

Inspiratory muscle training with sham device, 5 times a week for 12 weeks.

Control Group; Institutionalized therapeutic exercise + simulated inspiratory muscle training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with obesity within 1 month of bariatric surgery
• Both sexes
• Ages 18 to 60

You may not qualify if:

• Patients with respiratory conditions that contraindicate physical exercise
• Patients with diagnosed heart disease
• Patients with psychiatric conditions
• Patients with osteoarticular conditions that make physical exercise difficult

Sponsors & Collaborators

• University Ramon Llull: lead

Study Sites (1)

Carlos Andrade Marín Hospital

Quito, Pichincha, 08025, Ecuador

RECRUITING

Study Officials

• Jordi Vilaro, Phd

  University Ramon Llull

  STUDY CHAIR

Central Study Contacts

Jordi Vilaro, Phd

CONTACT

+34 666580946; jordivc@blanquerna.url.edu

Saúl Caicedo, Msc

CONTACT

+593980290110; saulalejandroct@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The randomization system will be carried out by a researcher who is not involved in the evaluation, intervention and data analysis. This researcher will be responsible for providing the respiratory muscle training devices for the different subject groups, delivering them in opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)