NCT04415788Completed
Inspiratory Muscle Training and COPD
Novel Versus Traditional Inspiratory Muscle Training Regimens as Home-based, Stand-alone Therapies in COPD
Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 1 Jun 2020
- Start date
- 1 May 2021
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Brno University Hospital
- Diseases
- COPD
- NCT number
- NCT04415788
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 1 May 2021 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- subjects with history of lung surgery, lung cancer,
- orthopedic, neurological or neuromuscular disorders
Other
- any diagnosed cognitive (i.e. Mini Mental State Examination score \< 24),
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.