Effects of Inspiratory Muscle Training on Parkinson's Disease

NCT ID: NCT06912997

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2026-01-31

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

The home-based inspiratory muscle training (IMT) protocol in experimental group will use an inspiratory threshold loading device (PowerBreathe Wellness, Southam, United Kingdom). IMT for experimental group will start with a minimal load (\~9 cmH2O) during the first week, aiming for a familiarization process. During the second week, the IMT targeted a moderate load of 45% of maximal inspiratory pressure (MIP) previously defined, which will be gradually increased by 10% of MIP each week until reaching 75% of MIP in the final week.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

The home-based inspiratory muscle training (IMT) protocol will use an inspiratory threshold loading device (PowerBreathe Wellness, Southam, United Kingdom). IMT for experimental group will start with a minimal load (\~9 cmH2O) during the first week, aiming for a familiarization process. During the second week, the IMT targeted a moderate load of 45% of maximal inspiratory pressure (MIP) previously defined, which will be gradually increased by 10% of MIP each week until reaching 75% of MIP in the final week.

Sham group

The Sham group will performer the same training protocol that experimental group, but at 5% of MIP during all weeks. Therefore, the sham group will not increase the training load during the protocol.

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: OTHER

The Sham group will performer the same training protocol that experimental group, but at 5% of MIP during all weeks. Therefore, the sham group will not increase the training load during the protocol.

Interventions

Exercise

The home-based inspiratory muscle training (IMT) protocol will use an inspiratory threshold loading device (PowerBreathe Wellness, Southam, United Kingdom). IMT for experimental group will start with a minimal load (\~9 cmH2O) during the first week, aiming for a familiarization process. During the second week, the IMT targeted a moderate load of 45% of maximal inspiratory pressure (MIP) previously defined, which will be gradually increased by 10% of MIP each week until reaching 75% of MIP in the final week.

Intervention Type: OTHER

Sham Comparator

The Sham group will performer the same training protocol that experimental group, but at 5% of MIP during all weeks. Therefore, the sham group will not increase the training load during the protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• active smokers or those who quit <5 years ago
• pulmonary or cardiovascular complications in the past 3 months
• arrhythmias or beta-blocker use
• Both groups required spirometry values >80% of predicted age

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Dias Rodrigues

PhD and Visiting Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal Fluminense

Niterói, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

58755522.5.0000.5243

Identifier Type: -

Identifier Source: org_study_id