Skip to main content
OpenTrials
Completed

NCT Number: NCT04415788

Inspiratory Muscle Training and COPD

Subjects with chronic obstructive pulmonary disease (COPD) frequently develop considerable deterioration in exercise capacity in association with weakness and deconditioning of the respiratory muscles, which can be corrected with specific therapies. While pulmonary rehabilitation is a central component in the rather complex manangement of COPD, there is currently a lack of centers able to provide appropriate rehabilitation services in the Czech Republic. The main objective of this study will be to fully evaluate the utility of the Test of Incremental Respiratory Endurance (TIRE) as an at-home inspiratory muscle training method in subjects with COPD, while comparing the effectiveness of this novel training approach to the outcomes of more traditional ispiratory muscle training protocols.

This prospective, randomized controlled trial will include 2 treatment groups and 1 sham intervention group in a 1:1:1 ratio. All participants will undergo a certain type of IMT regardless of group assignment, which will be perfomed via two different devices. The trial will comprise of an 8-week at-home training period with remote supervision followed by 4 months of unsupervised, independent inspiratory muscle training. Study outcomes will include measures of inspiratory muscle strength and endurance, pulmonary function, COPD-specific symptomatology, functional exercise capacity, surrogate markers of mortality risk, mental health status and health-related quality of life of participants. While investigators acknowledge the value of standard inspiratory muscle training protocols which use Threshold devices, investigators believe that the TIRE training has the potential to provide additional clinical benefits since it is able to modulate all aspects of muscular performance, including strength, endurance and work capacity. Investigators hypothesize that, as a home-based stand-alone rehabilitative therapy, TIRE will be superior to standard IMT in improving COPD-related measures.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Brno

Brno, 62500, Czechia

About this study

Eligible participants will be randomly assigned to one of the following three distinct home-based IMT protocols: (1) TIRE, (2) Standard, and (3) Sham (i.e. Low Resistance). All subjects will undergo 8 weeks of daily unsupervised IMT using either a PrO2® device (Design Net, Smithfield, USA) or Threshold device at home. All training modalities require the subjects to be seated and wearing a nose clip while performing the required breaths. Subjects will be instructed on respective training procedures and complete first training session in the presence of a research team member upon enrollment. Regardless of training method, participants will be instructed to fill in diary cards at the end of each training session, in which participants document how many breaths were able to perform. This information will be later used for compliance assessment. Participants will be also provided with user guides developed by investigators research team with detailed instructions regarding equipment set-up, training protocol and contact information. In addition, subjects will receive weekly phone calls from week 0 to week 8 to encourage compliance and adherence to the study protocol, to address any subject questions or concerns, and to collect information regarding participants current symptomatology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • individuals over the age of 40
  • clinical and functional diagnosis of COPD
  • Global Initiative of Chronic Obstructive Lung Disease (GOLD) - stages I to IV
  • evidence of inspiratory muscle weakness, defined as a MIP ≤ 80 cmH2O and a SMIP ≤ 427 PTU
  • ability to operate a computer, tablet or smartphone
  • clinical stability with no history of infections or exacerbation of respiratory symptoms for at least two months prior to study enrollment
  • non-participation in exercise programs in the past 12 months.

Exclusion criteria

  • subjects with history of lung surgery, lung cancer,
  • any diagnosed cognitive (i.e. Mini Mental State Examination score < 24),
  • orthopedic, neurological or neuromuscular disorders

Treatment and study plan

Test of Incremental Respiratory Endurance - IMT

Device

The TIRE training regimen will involve the use of a tablet provided to assigned subjects with the training software installed and a PrO2® device through which they will train. The software allows subjects to track their inspiratory muscle performance via real-time graphic representations of their efforts as training progresses.

Threshold - IMT

Device

The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.

Sham IMT (Low resistence)

Device

The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.

Primary outcomes

  1. Sustained Maximal Inspiratory Pressure (SMIP)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    The primary outcome measure will be SMIP, which will be obtained along with MIP and ID in every subject using the PrO2® device, an electronic pressure manometer which utilizes wireless technology to connect to a tablet containing the software of the Test of Incremental Respiratory Endurance.

Secondary outcomes

  1. Maximal Inspiratory Pressure (MIP)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    MIP will be obtained from a maximal inspiratory effort from residual volume using the TIRE software and recorded in centimeters of water.

  2. Inspiratory Duration (ID)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    ID will be obtained from a maximal and sustained inspiratory effort using the TIRE software and recorded in seconds.

Other outcomes

  1. Forced expiratory volume in the first second (FEV1)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    FEV1 will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body

  2. Inspiratory capacity (IC)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    IC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body

  3. Forced vital capacity (FVC)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    FVC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body

  4. Six-minute Walk Test (6MWT)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    Functional exercise capacity will be determined using the 6MWT. The best distance covered over a time of 6 minutes will be recorded in metres.

  5. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: Change from baseline to 8 weeks and 24 weeks

    This scale ranges from zero to four, with higher scores indicating a greater degree of breathlessness.

  6. Hospital Anxiety and Depression scale (HADS)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

  7. St.George's Respiratory Questionnaire (SGRQ)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.

  8. COPD Assessment Test (CAT)

    Time frame: Change from baseline to 8 weeks and 24 weeks

    This instrument that can quantify the impact of COPD on the patient's health. The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD.

  9. Satisfaction - self-completed questionnaire

    Time frame: Change from baseline to 8 weeks and 24 weeks

    Subjects will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which subjects will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

Novel Versus Traditional Inspiratory Muscle Training Regimens as Home-based, Stand-alone Therapies in COPD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2020
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.