NCT04481074

Brief Summary

The aim of this study is to evaluate the effects of inspiratory muscle training program in inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

July 17, 2020

Last Update Submit

February 2, 2022

Conditions

Interstitial FibrosisPulmonary DiseaseInterstitial Lung DiseaseSarcoidosisIdiopathic Pulmonary FibrosisPneumonia, Interstitial

Keywords

Inspiratory muscle trainingInterstitial lung diseaseInspiratory muscle enduranceBreathless

Outcome Measures

Primary Outcomes (2)

  • Change in Inspiratory muscle endurance

    Endurance time in seconds

    At baseline and after 8 weeks of training

  • Change in Breathlessness

    Medical Research Council (1-5)

    At baseline and after 8 weeks of training

Secondary Outcomes (3)

  • Change in Inspiratory muscle strength

    At baseline and after 8 weeks of training

  • Change in Functional capacity

    At baseline and after 8 weeks of training

  • Change in Quality of life

    At baseline and after 8 weeks of training

Study Arms (1)

Inspiratory muscle training group

EXPERIMENTAL

Group intervention: home-based interval inspiratory muscle training during 8 weeks, two sessions with two sets of 30 breaths with one minute rest between them. Load set is determinated weekly, aiming 50% of actual PImax and according to Borg Score.

Other: Inspiratory muscle training

Interventions

Inspiratory muscle trainingOTHER

Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).

Inspiratory muscle training group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and radiological diagnosis of interstitial lung disease established by a pulmonologist;
  • Absence of clinical exacerbations of the disease in the four weeks prior to the initial data collection;
  • Present medical research council scale more than 2;
  • Absence of a associated or self reported cardiac, orthopedic and psychiatric diseases,
  • Not participating in pulmonary rehabilitation programs;
  • Do not use supplemental oxygen therapy while resting.

You may not qualify if:

  • \- Inability of the participant to understand or perform the procedures proposed during the evaluations and training program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.

Belo Horizonte, Minas Gerais, 30150-260, Brazil

Location

Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Pulmonary FibrosisLung DiseasesLung Diseases, InterstitialSarcoidosisIdiopathic Pulmonary FibrosisDyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

July 30, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 3, 2022

Record last verified: 2022-02

Locations

BR(2)