Inspiratory Muscle Training in Individuals With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737630
• Other study ID #: 1a2b3c4d5e
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 31, 2020
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

Inclusion Criteria:

• Diagnosis of cystic fibrosis, confirmed by the sweat test;

• 14 - 25 years;

• Clinical stability;

• Absence of bacterial colonization for 4 weeks;

• Both sexes;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Inspiratory muscle training
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

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Norte	Natal	Rio Grande Do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Posture at 4 weeks	Inclinometer Danoplus®	Baseline and after 4 weeks of training
Primary	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	Change from baseline Respiratory muscle strength at 4 weeks	MVD300®	Baseline and after 4 weeks of training
Secondary	Change from baseline Pulmonary function at 4 weeks	Spirometry test using Koko® device	Baseline and after 4 weeks of training
Secondary	Change from baseline Functional capacity at 4 weeks	three-minute step test	Baseline and after 4 weeks of training