Effects of Inspiratory Muscle Training on Parkinson's Disease (IMT_PD)

April 2, 2025 updated by: Gabriel Dias Rodrigues, Universidade Federal Fluminense

Effects of Inspiratory Muscle Training on Hemodynamic and Cerebrovascular Responses During Maintenance of Postural Balance in Parkinson's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Niterói, RJ, Brazil, 24033-900
        • Universidade Federal Fluminense

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
center of pressure of the body
Time Frame: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cerebral blood flow
Time Frame: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
In order to estimate changes in cerebral perfusion, the blood flow velocity in the middle cerebral artery (MCAv) will be used, insonated using a pulsed transcranial ultrasound Doppler with 2-MHz waves. The transducer will be positioned over the right temporal window in all participants, fixed with an adjustable headband. The insonation depth will be 20 and 60 mm, depending on the anatomical positioning of the vessel, to ensure the best signal quality. The cerebral vascular conductance index (CVCi) will be calculated as the mean of the MCAv divided by the mean arterial pressure (MAP) obtained through photoplethysmography. This index will be used as a way to estimate changes in cerebrovascular conductance.Cerebral autoregulation will be dynamically assessed by the cerebral autoregulation index (RoR), calculated using the following formula: RoR = (ΔCVCi/ΔT)/ΔMAP. The first field of the formula consists of a linear regression between CVCi and time. The delta MAP will be obtained.
Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Hemodynamic variables
Time Frame: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Blood pressure will be recorded beat-to-beat using infrared photoplethysmography (FinometerPro; Finapres Medical Systems, Arnhem, The Netherlands), R-R intervals using electrocardiography (Equivital, ADinstruments, AUS), and stroke volume and cardiac output will be recorded noninvasively using transthoracic impedance (PhysioFlow, PF-05, Manatec Biomedical, Macheren, France). All variables will be recorded simultaneously at a sampling rate of 1 kHz and analyzed offline using a data acquisition system and data analysis software (PowerLab 16SP hardware and LabChart 8 PRO software; ADInstruments, Australia).
Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Metabolic and Ventilatory Variables
Time Frame: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Metabolic and ventilatory variables will be acquired by a metabolic gas analyzer (Ultima CPX; Medgraphics, St. Paul, MN, USA) and a medium-flow pneumotachograph (Medgraphics, St. Paul, MN, USA). The device will be calibrated at the beginning of each test using a 3-L cylinder. The variables recorded will be minute ventilation (VE), tidal volume (Vt), expired carbon dioxide pressure (PetCO2), expiratory time (Te), inspiratory time (Ti), the ratio between Ti and total respiratory time (Ti/Ttot) and between Vt and Ti (Vt/Ti).
Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 58755522.5.0000.5243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings