NCT05608941Completed
High-Intensity Respiratory Muscle Training in Individuals With Parkinson's Disease
Effects of High-Intensity Respiratory Muscle Training on Respiratory Muscle Strength, Functional Outcomes and Quality of Life in Individuals With Parkinson's Disease: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 26 Sept 2024
Brief summary (registry, in English)
Background: Individuals with PD commonly have a significant reduction in respiratory muscle strength and inspiratory muscle endurance, and it can intensify with the disease progression. Respiratory muscle training has shown to increase respiratory muscle strength in individuals with Parkinson's Disease (PD). However, the effect size on other functional outcomes has not been determined and/or investigated. In addition, no studies have investigated the effects of high-intensity respiratory muscle training (inspiratory and expiratory) in this population. Objectives: The primary aim of this study will be to investigate the effects of high-intensity respiratory muscle training on inspiratory and expiratory muscle strength in individuals with PD. The secondary aim of this study will be to investigate the efficacy of high-intensity respiratory muscle training in improving inspiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life in this population. Design: A randomized controlled trial with blinded assessment will assign eligible participants to either: high-intensity respiratory muscle training (experimental group) or sham training (control group). Individuals will perform a home-based intervention, not directly supervised, consisted of two daily 20-min sessions (morning and afternoon), seven times a week, during eight weeks. Study Outcomes: Primary outcomes are inspiratory and expiratory muscle strength (MIP and MEP). Secondary outcomes are respiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life.The outcomes will be measured at baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up). Conclusion: The results of this trial will provide valuable new information on the efficacy of high-intensity respiratory muscle training in improving muscle strength and other functional outcomes in individuals with PD.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 27 Oct 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Federal University of Minas Gerais
- Diseases
- Parkinson disease
- NCT number
- NCT05608941
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 1 Dec 2022 to the primary completion date, 30 Apr 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
- Possible cognitive impairment as determined by cutoff scores (in points) of the Mini-Mental Status Examination
- Smokers or who stopped smoking less than six months ago; have been affected by respiratory or cardiac infections in the last month
- Had any other neurological, musculoskeletal, cardiovascular or respiratory disorders that could affect their ability to perform the tests
Other
- Use deep brain stimulation (DBS)
Who the study is looking for
- Parkinson's disease diagnosed by a neurologist
- Ability to walk independently, with or without assistive devices
- Taking anti parkinsonian medication, and who have been medically stable for at least six months
- Classified between stages 1-3 of the modified Hoehn \& Yahr Scale (Schenkman et al., 2001)
- Maximum inspiratory pressure less or equal to -80 cmH2O or maximum expiratory pressure less or equal to 90 cmH2O
Age in the registry: 50 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 |
|---|---|---|---|
| Federal University of Minas Gerais Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.