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Inspiratory Muscle Training in Individuals With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, quality of life, posture

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidade Federal do Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GExp

GCon

Arm Description

This group will perform the inspiratory muscle training with moderate load

This group will initiate inspiratory muscle training with low load

Outcomes

Primary Outcome Measures

Change from baseline Posture at 4 weeks
Inclinometer Danoplus®
Change from baseline Health-related quality of life at 4 weeks
Health-related quality of life questionnaire (HRQoL)

Secondary Outcome Measures

Change from baseline Respiratory muscle strength at 4 weeks
MVD300®
Change from baseline Pulmonary function at 4 weeks
Spirometry test using Koko® device
Change from baseline Functional capacity at 4 weeks
three-minute step test

Full Information

First Posted
November 6, 2018
Last Updated
April 14, 2020
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03737630
Brief Title
Inspiratory Muscle Training in Individuals With Cystic Fibrosis
Official Title
Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, quality of life, posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GExp
Arm Type
Experimental
Arm Description
This group will perform the inspiratory muscle training with moderate load
Arm Title
GCon
Arm Type
Active Comparator
Arm Description
This group will initiate inspiratory muscle training with low load
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Posture at 4 weeks
Description
Inclinometer Danoplus®
Time Frame
Baseline and after 4 weeks of training
Title
Change from baseline Health-related quality of life at 4 weeks
Description
Health-related quality of life questionnaire (HRQoL)
Time Frame
Baseline and after 4 weeks of training
Secondary Outcome Measure Information:
Title
Change from baseline Respiratory muscle strength at 4 weeks
Description
MVD300®
Time Frame
Baseline and after 4 weeks of training
Title
Change from baseline Pulmonary function at 4 weeks
Description
Spirometry test using Koko® device
Time Frame
Baseline and after 4 weeks of training
Title
Change from baseline Functional capacity at 4 weeks
Description
three-minute step test
Time Frame
Baseline and after 4 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Oliveira, Master
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte
City
Natal
State/Province
Rio Grande Do Norte
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33331663
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.
Results Reference
derived

Learn more about this trial

Inspiratory Muscle Training in Individuals With Cystic Fibrosis

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