Inspiratory Muscle Training in Individuals With Cystic Fibrosis

Effects of Inspiratory Muscle Training in Individuals Who Have 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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: Inspiratory muscle training

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil
      • Universidade Federal do Rio Grande do Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GExp; This group will perform the inspiratory muscle training with moderate load	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
ACTIVE_COMPARATOR: GCon; This group will initiate inspiratory muscle training with low load	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Respiratory muscle strength at 4 weeks	MVD300®	Baseline and after 4 weeks of training
Change from baseline Pulmonary function at 4 weeks	Spirometry test using Koko® device	Baseline and after 4 weeks of training
Change from baseline Functional capacity at 4 weeks	three-minute step test	Baseline and after 4 weeks of training

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Study Chair: Victor Oliveira, Master, Universidade Federal do Rio Grande do Norte

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 5, 2019
• Primary Completion (ACTUAL): October 18, 2019
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (ACTUAL): November 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; cystic fibrosis; posture
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 1a2b3c4d5e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No