Inspiratory Muscle Training in Individuals With Cystic Fibrosis

NCT03737630 | Completed

• 1 other identifier: 1a2b3c4d5e
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; quality of life; posture

Outcome Measures

Primary Outcomes (2)

• Change from baseline Posture at 4 weeks

  Inclinometer Danoplus®

  Baseline and after 4 weeks of training

• Change from baseline Health-related quality of life at 4 weeks

  Health-related quality of life questionnaire (HRQoL)

  Baseline and after 4 weeks of training

Secondary Outcomes (3)

• Change from baseline Respiratory muscle strength at 4 weeks

  Baseline and after 4 weeks of training

• Change from baseline Pulmonary function at 4 weeks

  Baseline and after 4 weeks of training

• Change from baseline Functional capacity at 4 weeks

  Baseline and after 4 weeks of training

Study Arms (2)

GExp

EXPERIMENTAL

This group will perform the inspiratory muscle training with moderate load

Device: Inspiratory muscle training

GCon

ACTIVE COMPARATOR

This group will initiate inspiratory muscle training with low load

Device: Inspiratory muscle training

Interventions

Inspiratory muscle training DEVICE

This group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training

GCon; GExp

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of cystic fibrosis, confirmed by the sweat test;
• years;
• Clinical stability;
• Absence of bacterial colonization for 4 weeks;
• Both sexes;

You may not qualify if:

• Inability to perform the protocol established by the study;
• Present any intercurrence during data collection;
• Being unable to understand and / or perform procedures.
• Colonization during study participation;
• Patient hospitalization due to worsening of the clinical picture.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Location

Related Publications (1)

• Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5.

  PMID: 33331663 DERIVED

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

• Victor Oliveira, Master

  Universidade Federal do Rio Grande do Norte

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: August 5, 2019
• Primary Completion: October 18, 2019
• Study Completion: January 31, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)