Modeling of Chest Physiotherapy Using Impedance Measurements (PHYSIOMOD)

NCT04094441 | Completed

• 1 other identifier: N° IDRCB: 2017-A02426-47
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

"The usefulness of respiratory physiotherapy and its execution modalities remains highly debated even though reviews of the literature show that respiratory physiotherapy is able to improve the drainage of bronchial secretions and pulmonary function tests during cystic fibrosis in periods of stability. Different physiotherapy techniques have been developed but the choice of one or the other facing a patient can not currently be recommended. The VirtualChest project, supported by a grant from the National Agency for Research (ANR), aims to develop and validate a physical model of respiratory physiotherapy (6 stages including model establishment pulmonary: bronchial tree and pulmonary mechanics and parietal \[steps 1 and 3\], a model of mucus \[step 2\] and modeling the effect of physiotherapy \[step 5\]). This project is integrated with stages 3 and 5 of this broad project and aims to get on a limited number of children with cystic fibrosis a proof of concept (prediction of drainage efficiency) and especially to feed the proposed physical models in order to subsequent optimization of the model (step 6). The choice cystic fibrosis of the child was justified by the effect demonstrated respiratory physiotherapy, particularly on respiratory functional criteria, and the fact that the parietal mechanics varies physiologically at this age."

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Impedance measurements will be obtained before and after chest physiotherapy using the Impulse Oscillometry System.

  Impedance of the respiratory system: Z5Hz, Z10Hz, Z20Hz, Z35Hz, R5Hz (respiratory system resistance), X5Hz (respiratory system reactance), R5-20Hz (difference R5 - R20Hz)

  2 hours

Study Arms (1)

additional pulmonary function tests

EXPERIMENTAL

additional pulmonary function tests

Other: chest physiotherapy

Interventions

chest physiotherapy OTHER

chest physiotherapy

additional pulmonary function tests

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of cystic fibrosis
• Physiotherapy session is programmed

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Related Publications (1)

• Bokov P, Gerardin M, Brialix G, Da Costa Noble E, Juif R, Foucher AV, Le Clainche L, Houdouin V, Mauroy B, Delclaux C. Beneficial short-term effect of autogenic drainage on peripheral resistance in childhood cystic fibrosis disease. BMC Pulm Med. 2022 Jun 21;22(1):241. doi: 10.1186/s12890-022-02039-2.

  PMID: 35729620 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Christophe Delclaux, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one arm, the interventional design is related to additional pulmonary function tests

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 19, 2019
• Study Start: January 10, 2019
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: February 3, 2023

Record last verified: 2019-08

Locations

FR (1)