Effects of Inspiratory Muscle Training on Parkinson's Disease

NCT06912997 | Active Not Recruiting DMC

• 1 other identifier: 58755522.5.0000.5243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Neurodegenerative disease; Movement disorder; Postural balance; respiratory training; inspiratory training; Physical exercise; Cerebrovascular control; blood pressure; cardiovascular autonomic control

Outcome Measures

Primary Outcomes (1)

• center of pressure of the body

  The variables related to postural balance will be performed on a force platform (Accusway Dual Top, USA) in a bipedal position. The participants' feet will be positioned with the heels together and with a 30° gap between the feet. Throughout the test, the individual's center of pressure (COP) will be continuously recorded, determined as a neuromuscular response to the location of the center of gravity (COG). The starting point used for the assessment will be considered the moment when the individual reaches the orthostatic position, for which the highest value of the weight force (Fz) will be obtained. The elliptical area, the total distance and the displacement speed COPxy will be calculated as COP variables. The signals will be filtered at a frequency of 50 Hz as a Hamming window and a "low-pass" filter to reduce interference.

  Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)

Secondary Outcomes (3)

• cerebral blood flow

  Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)

• Hemodynamic variables

  Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)

• Metabolic and Ventilatory Variables

  Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Exercise

Sham group

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.

Other: Sham Comparator

Interventions

Exercise 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.

Experimental group

Sham Comparator 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.

Sham group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Niterói, Rio de Janeiro, 24033-900, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases; Movement Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD and Visiting Professor

Model Details: A training group and a placebo group (sham)

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 6, 2025
• Study Start: July 10, 2024
• Primary Completion: August 1, 2025
• Study Completion: January 31, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)