Inspiratory Muscle Training in Individuals With Cystic Fibrosis

NCT ID: NCT03737630

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2020-01-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GExp

This group will perform the inspiratory muscle training with moderate load

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: 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

GCon

This group will initiate inspiratory muscle training with low load

Group Type: ACTIVE_COMPARATOR

Inspiratory muscle training

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Patri-cia Angelica de Miranda Silva Nogueira

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Oliveira, Master

Role: STUDY_CHAIR

Universidade Federal do Rio Grande do Norte

Locations

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33331663 (View on PubMed)

Other Identifiers

1a2b3c4d5e

Identifier Type: -

Identifier Source: org_study_id