Inspiratory Muscle Training and COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04415788
• Other study ID #: BrnoUH RHO AZVj 2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Device:
• Test of Incremental Respiratory Endurance - IMT
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
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)
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.

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Formiga MF, Dosbaba F, Hartman M, Batalik L, Plutinsky M, Brat K, Ludka O, Cahalin LP. Novel versus Traditional Inspiratory Muscle Training Regimens as Home-Based, Stand-Alone Therapies in COPD: Protocol for a Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Sep 11;15:2147-2155. doi: 10.2147/COPD.S266234. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Forced expiratory volume in the first second (FEV1)	FEV1 will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body	Change from baseline to 8 weeks and 24 weeks
Other	Inspiratory capacity (IC)	IC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body	Change from baseline to 8 weeks and 24 weeks
Other	Forced vital capacity (FVC)	FVC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body	Change from baseline to 8 weeks and 24 weeks
Other	Six-minute Walk Test (6MWT)	Functional exercise capacity will be determined using the 6MWT. The best distance covered over a time of 6 minutes will be recorded in metres.	Change from baseline to 8 weeks and 24 weeks
Other	Modified Medical Research Council (mMRC) Dyspnea Scale	This scale ranges from zero to four, with higher scores indicating a greater degree of breathlessness.	Change from baseline to 8 weeks and 24 weeks
Other	Hospital Anxiety and Depression scale (HADS)	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.	Change from baseline to 8 weeks and 24 weeks
Other	St.George's Respiratory Questionnaire (SGRQ)	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.	Change from baseline to 8 weeks and 24 weeks
Other	COPD Assessment Test (CAT)	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.	Change from baseline to 8 weeks and 24 weeks
Other	Satisfaction - self-completed questionnaire	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").	Change from baseline to 8 weeks and 24 weeks
Primary	Sustained Maximal Inspiratory Pressure (SMIP)	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.	Change from baseline to 8 weeks and 24 weeks
Secondary	Maximal Inspiratory Pressure (MIP)	MIP will be obtained from a maximal inspiratory effort from residual volume using the TIRE software and recorded in centimeters of water.	Change from baseline to 8 weeks and 24 weeks
Secondary	Inspiratory Duration (ID)	ID will be obtained from a maximal and sustained inspiratory effort using the TIRE software and recorded in seconds.	Change from baseline to 8 weeks and 24 weeks

External Links

•   article link