Inspiratory Muscle Training and COPD

NCT04415788 | Completed

• 1 other identifier: BrnoUH RHO AZVj 2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Pulmonary rehabilitation; Telemedicine; Quality of life; Inspiratory muscle training; Test of incremental respiratory endurance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximal Inspiratory Pressure (MIP)

  Change from baseline to 8 weeks and 24 weeks

• Inspiratory Duration (ID)

  Change from baseline to 8 weeks and 24 weeks

Other Outcomes (9)

• Forced expiratory volume in the first second (FEV1)

  Change from baseline to 8 weeks and 24 weeks

• Inspiratory capacity (IC)

  Change from baseline to 8 weeks and 24 weeks

• Forced vital capacity (FVC)

  Change from baseline to 8 weeks and 24 weeks

Study Arms (3)

Test of Incremental Respiratory Endurance - IMT

EXPERIMENTAL

Training will consist of six levels (A-F) with six inspirations at each level for up to 36 breaths per session. TIRE data will be stored in the tablet and automatically synced to account on cloud-based online platform for subsequent interrogation and data retrieval. Before every training session, subjects will be required to complete one maximal and sustained inspiratory effort from which the training is based on for that day.

Device: Test of Incremental Respiratory Endurance - IMT

Threshold - IMT

EXPERIMENTAL

Subjects assigned to the Standard training regimen will receive a commonly used Threshold inspiratory muscle trainer. This device features a one-way spring-loaded valve at one end and a mouthpiece on the other through which subjects will be required to breathe in hard enough to overcome the resistance provided by the spring-loaded valve, allowing correct inspiration to happen. In other words, air flow is blocked until subjects generate sufficient inspiratory pressure to exceed the device pre-set pressure in cmH2O. The resistance will be set using the device's adjustable pressure setting which is fixed at 50% of the subject's MIP at the time of enrollment. The resistance will be readjusted as needed at week 4 to still reflect 50% of their inspiratory muscle strength at that time. Subjects will be coached to perform up to 36 breaths daily using the device. They will be also instructed to complete the training session within a 30-minute period.

Device: Threshold - IMT

Sham IMT (Low resistence)

SHAM COMPARATOR

The Sham (Low Resistance) training regimen will use the same methods described above for the Standard IMT, except for the amount of resistance applied within the device. Subjects will receive a Threshold which has been set to its minimal resistance, which is 9 cmH2O. Again, subjects will be instructed to perform up to 36 breaths daily using the device within a 30-minute period.

Device: Sham IMT (Low resistence)

Interventions

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.

Test of Incremental Respiratory Endurance - IMT

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.

Threshold - IMT

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.

Sham IMT (Low resistence)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

Location

Related 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.

  PMID: 32982207 BACKGROUND

Related Links

• article link

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Filip Dosbaba, PT, PhD

  University Hospital Brno, Czech Republic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: May 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

CZ (1)