Inspiratory Muscle Training in Individuals With Cystic Fibrosis

Sponsor

Universidade Federal do Rio Grande do Norte (Other)

Overall Status

Completed

CT.gov ID

NCT03737630

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Aug 5, 2019

Actual Primary Completion Date :

Oct 18, 2019

Actual Study Completion Date :

Jan 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

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

Change from baseline Posture at 4 weeks [Baseline and after 4 weeks of training]
Inclinometer Danoplus®
Change from baseline Health-related quality of life at 4 weeks [Baseline and after 4 weeks of training]
Health-related quality of life questionnaire (HRQoL)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Nov 9, 2018

Last Update Posted:

Apr 16, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

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

cystic fibrosis

quality of life

posture

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Apr 16, 2020