Clinical trial NCT03737630: Inspiratory Muscle Training in Individuals With Cystic Fibrosis
Official title: Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
quality of life
posture
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Posture at 4 weeks
timeFrame: Baseline and after 4 weeks of training
measure: Change from baseline Health-related quality of life at 4 weeks
timeFrame: Baseline and after 4 weeks of training
Secondary outcomes:
measure: Change from baseline Respiratory muscle strength at 4 weeks
timeFrame: Baseline and after 4 weeks of training
measure: Change from baseline Pulmonary function at 4 weeks
timeFrame: Baseline and after 4 weeks of training
measure: Change from baseline Functional capacity at 4 weeks
timeFrame: Baseline and after 4 weeks of training
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte
state: Rio Grande Do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Victor Oliveira, Master
role: STUDY_CHAIR
References:
citation: 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.