NCT06912997Active, not recruiting
Effects of Inspiratory Muscle Training on Parkinson's Disease
Effects of Inspiratory Muscle Training on Hemodynamic and Cerebrovascular Responses During Maintenance of Postural Balance in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
Parkinson's disease (PD) is a neurodegenerative movement disorder that provoke motors and non-motors symptoms causing further dependence and disability. Among non-motor issues, orthostatic hypotension (OH) is a severe manifestation of autonomic dysfunctions, occurring in approximately 30% of those with PD. The fall in blood pressure (BP) during orthostatic position (ORT) is normally compensated to maintain adequate cerebral blood flow (CBF) through autoregulation of cerebral vessels (AC). However, if AC is compromised, CBF may decrease and cause pre-syncope symptoms such as dizziness and loss of balance. Inspiratory muscle training (IMT) is a non-pharmacological strategy to improve respiratory muscle strength, cerebrovascular, cardiovascular control in several populations. However, the effects of IMT on cardiovascular autonomic control (i.e. baroreflex sensitivity-BRS), hemodynamic and AC during ORT in PD patients with and without orthostatic hypotension have not yet been studied. Our hypothesis is that IMT will increase inspiratory muscle strength and influence spontaneous breathing pattern, improving BRS. In addition, IMT will cause a smaller drop in BP and CBF during ORT. Furthermore, maintaining CBF will reduce postural instability during ORT. PD patients without and with OH (PD-OH) will participate in the study and will be randomly divided into two groups recruited at the Antônio Pedro University Hospital. The experimental group will perform 6-8 weeks of training at 30-75% of maximum inspiratory pressure (MIP), and the placebo group will perform the same training protocol at 5% of MIP (sham). The home-based protocol will be of 30 repetitions twice a day, five days a week. In active ORT test, BP, R-R intervals, stroke volume, cardiac output, respiratory rate, ventilatory variables and mean cerebral blood flow velocity (MCAv) will be continuously monitored for 10 minutes in the supine position (SUP), 10 minutes in the sitting position and then 6 minutes in the ORT position. Oscillations of the body's center of pressure (COP), through a force platform, and neuromuscular responses of the gastrocnemius and tibialis anterior muscles, through surface electromyography, will be recorded while maintaining the ORT position. The orthostatic test will be performed before and after the interventions (placebo and experimental). We believe that IMT will promote an improvement in BRS, AC, and postural control, presenting itself as a potential non-pharmacological countermeasure in autonomic dysfunctions and in the prevention of falls in Parkinson's disease.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 19 Mar 2025
- Start date
- 10 Jul 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Universidade Federal Fluminense
- Diseases
- Parkinson disease
- NCT number
- NCT06912997
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 10 Jul 2024 to the primary completion date, Aug 2025
- 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
- arrhythmias or beta-blocker use
Age
- active smokers or those who quit \<5 years ago
- Both groups required spirometry values \>80% of predicted age
Other
- pulmonary or cardiovascular complications in the past 3 months
Who the study is looking for
- diagnosis of idiopathic PD according to Movement Disorder Society (MDS) criteria
- treatment at Antonio Pedro Hospital (HUAP) for \>6 months;
- stable Parkinson's medication for at least 30 days prior to testing.
Age in the registry: 45 years to 85 years · 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 |
|---|---|---|---|
| Universidade Federal Fluminense Coordinator of this site? Confirm its status | Niterói | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.