Definition of Respiratory Training Protocols in Obese Patients (PROALRESPIOB)

NCT05759611 | Completed

• 1 other identifier: 01C024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The project is aimed at investigating the effectiveness of respiratory training protocols in relieving exercise dyspnea, improving respiratory efficiency and the ability to perform physical activity, even daily, in obese patients. Therefore, some respiratory exercises with different characteristics and mechanisms of action will be introduced into the standard program of integrated metabolic rehabilitation implemented at the Istituto Auxologico Italiano, Piancavallo, Italy (Division of Auxology and Division of Metabolic Diseases) in order to identify a suitable training protocol for this population, the development of which can be carried out over time by patients even autonomously (Sheel and Dominelli 2019). The definition of the protocols will be 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 will be adapted to the obese patient.

Conditions

Obesity

Keywords

Obesity; Respiratory training; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• V'O2 peak during physical exercise protocol

  Change in V'O2 peak

  Baseline and at the end of the training program (21 days)

• Arterial saturation of O2 during physical exercise protocol

  Change in arterial saturation of O2

  Baseline and at the end of the training program (21 days)

Secondary Outcomes (1)

• Heart rate during physical exercise protocol

  Baseline and at the end of the training program (21 days)

Study Arms (2)

Control group (CTRL)

OTHER

Other: Standard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises

Experimental group (RMT)

EXPERIMENTAL

Other: Standard integrated metabolic rehabilitation protocol + specific respiratory muscle training program

Interventions

Standard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises OTHER

Physical exercise protocol before and after 12 sessions of standard integrated metabolic rehabilitation protocol + guided spontaneous breathing exercises lasting about 20 minutes per session

Control group (CTRL)

Standard integrated metabolic rehabilitation protocol + specific respiratory muscle training program OTHER

Physical exercise protocol before and after 12 sessions of standard integrated metabolic rehabilitation protocol + a 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 patients aged \< 18 years and BMI \> 35 for patients aged \> 18 years;
• absence of structured physical activity programs (regular activity for more than 120 min/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:

• presence of structured physical activity programs (regular activity for more than 120 min/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: July 21, 2021
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

IT (1)