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Effect of Respiratory Training Protocols on GH Secretion in Obesity (ALRESPGHOB)

NCT05759598 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-03-09

No results posted yet for this study

Summary

The study's primary objective is to evaluate the acute and chronic (3 weeks) effects of two respiratory training protocols in obese adolescents (performed during a period of hospitalization for a body weight reduction program), with different characteristics and mechanisms of action, on GH and IGF-I secretion. The definition of the protocols is based on what has been observed by recent studies conducted on healthy people (Wuthrich et al., 2015; Schaer et al., 2018) and on patient populations in which respiratory dysfunction is a primary or secondary component of the pathology (Calcaterra et al., 2014; Pomidori et al., 2009). All planned interventions are safe and are adapted to the obese patient.

Project objectives are:

* assessment of GH-IGF-I responses (baseline), during the first training session of the respiratory muscles conducted in the first days of hospitalization of the patients in the clinic
* assessment of GH-IGF-I responses (post), during the last training session of the respiratory muscles conducted at the end of the three weeks of each training session

Conditions

Interventions

OTHER

Rehabilitation protocol + guided spontaneous breathing exercises

Standard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises

OTHER

Rehabilitation protocol + specific respiratory muscle training program

Standard integrated metabolic rehabilitation protocol + specific respiratory muscle training program according to the protocol recently proposed by Spengler et al. (Wuthrich et al., 2015; Schaer et al., 2018), adapted according to the baseline characteristics of the respiratory function of the subjects

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2022-06-08
Completion
2022-06-08

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759598 on ClinicalTrials.gov