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Effects of Home-based Inspiratory Muscle Training in Patients With IPF

D

Dokuz Eylül University (DEU)

Status

Completed

Conditions

IPF
Idiopathic Pulmonary Fibrosis

Treatments

Device: Inspiratory Muscle Training (IMT)
Device: Sham IMT

Study type

Interventional

Funder types

Other

Identifiers

NCT05353556
RidvanAktan_2022/04-03

Details and patient eligibility

About

The aim of this study is to investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Full description

The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Enrollment

28 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosing Idiopathic Pulmonary Fibrosis by a pulmonologist;
  • Aged between 40 and 75 years;
  • Volunteering to research;
  • Stable clinical condition (same medication routine and/or no acute exacerbation in the last for the last 4 weeks).

Exclusion criteria

  • Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
  • Participating in any pulmonary rehabilitation programs;
  • A previous pneumonectomy or lobectomy operation;
  • Pneumonia in the last 4 weeks;
  • Any pulmonary infection during the study;
  • Requirement for supplemental oxygen therapy while resting.
  • Having Covid-19 disease (during the study or in the past)
  • Orthopaedic or neurological conditions affecting the ability to independent walking

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups

Study Group
Experimental group
Description:
Patients who perform inspiratory muscle training (IMT) with %50 loading
Treatment:
Device: Inspiratory Muscle Training (IMT)
Sham Group
Sham Comparator group
Description:
Patients who perform Sham IMT
Treatment:
Device: Sham IMT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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