Inspiratory Muscle Training in Individuals With Cystic Fibrosis

• ClinicalTrials.gov Identifier: NCT03737630
• Recruitment Status: Completed
• First Posted: November 9, 2018
• Last Update Posted: April 16, 2020
• Sponsor: Universidade Federal do Rio Grande do Norte
• Information provided by (Responsible Party): Patri-cia Angelica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do Norte

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Device: Inspiratory muscle training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis
• Actual Study Start Date: August 5, 2019
• Actual Primary Completion Date: October 18, 2019
• Actual Study Completion Date: January 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande Do Norte, Brazil

Sponsors and Collaborators

Universidade Federal do Rio Grande do Norte

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

• Responsible Party: Patri-cia Angelica de Miranda Silva Nogueira, PhD, Universidade Federal do Rio Grande do Norte
• ClinicalTrials.gov Identifier: NCT03737630
• Other Study ID Numbers: 1a2b3c4d5e
• First Posted: November 9, 2018
• Last Update Posted: April 16, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patri-cia Angelica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do Norte:

cystic fibrosis; quality of life; posture

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases