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Completed

NCT Number: NCT03737630

Inspiratory Muscle Training in Individuals With Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change from baseline Posture at 4 weeks

    Time frame: Baseline and after 4 weeks of training

    Inclinometer Danoplus®

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

    Time frame: Baseline and after 4 weeks of training

    Health-related quality of life questionnaire (HRQoL)

Secondary outcomes

  1. Change from baseline Respiratory muscle strength at 4 weeks

    Time frame: Baseline and after 4 weeks of training

    MVD300®

  2. Change from baseline Pulmonary function at 4 weeks

    Time frame: Baseline and after 4 weeks of training

    Spirometry test using Koko® device

  3. Change from baseline Functional capacity at 4 weeks

    Time frame: Baseline and after 4 weeks of training

    three-minute step test

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 9, 2018
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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