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

NCT05759598 | Terminated

• 1 other identifier: 01C020
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Growth hormone; Insulin-like growth factor; Training of respiratory muscles

Outcome Measures

Primary Outcomes (2)

• Growth hormone (GH)

  Change in plasma concentration of growth hormone

  Baseline, 0, 15, 30 and 45 minutes after Intervention and 3 weeks after intervention

• Insulin-like growth factor (IGF-I)

  Change in plasma concentration of insulin-like growth factor

  Baseline and 0 minutes after Intervention

Study Arms (2)

Control group (CTRL)

OTHER

Other: Rehabilitation protocol + guided spontaneous breathing exercises

Experimental group (RMT)

EXPERIMENTAL

Other: Rehabilitation protocol + specific respiratory muscle training program

Interventions

Rehabilitation protocol + guided spontaneous breathing exercises OTHER

Standard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises

Control group (CTRL)

Rehabilitation protocol + specific respiratory muscle training program OTHER

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

Experimental group (RMT)

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI standard deviation score (SDS) \> 2 for subjects aged \< 18 years and BMI \> 35 for patients aged \>18 years;
• absence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
• absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.

You may not qualify if:

• age \< 14 years and \> 30 years;
• presence of structured physical activity programs (regular activity for more than 120 minutes/week) during the 6 months preceding the study;
• presence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal, or musculoskeletal pathologies contraindicated for carrying out the tests.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: October 14, 2021
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

IT (1)