Parkinson DiseaseIMT_PDNCT06912997
Effects of Inspiratory Muscle Training on Parkinson's Disease
A study testing Exercise in people with Parkinson Disease, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal Fluminense
Niterói, Rio de Janeiro, 24033-900
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Exercise, Sham Comparator
- Keywords
- Neurodegenerative disease, Movement disorder, Postural balance, respiratory training, inspiratory training, Physical exercise, Cerebrovascular control, blood pressure, cardiovascular autonomic control
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases, Movement Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 ComparatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Secondary outcomes (3)
cerebral blood flow
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.
Measured: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Hemodynamic variables
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).
Measured: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Metabolic and Ventilatory Variables
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).
Measured: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start10 Jul 2024
- Primary completionAug 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A training group and a placebo group (sham)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Dias Rodrigues, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912997
- Sponsor's protocol ID
- 58755522.5.0000.5243
- Acronym
- IMT_PD
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Hemodynamic and Cerebrovascular Responses During Maintenance of Postural Balance in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06912997
- Acronym / sponsor ID
- IMT_PD / 58755522.5.0000.5243
- Conditions
- Parkinson Disease
- Keywords
- Neurodegenerative disease, Movement disorder, Postural balance, respiratory training, inspiratory training, Physical exercise, Cerebrovascular control, blood pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A training group and a placebo group (sham)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ExerciseThe 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. |
| Sham group | Sham comparator | Other: Sham ComparatorThe 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Experimental group |
| Sham ComparatorThe 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 group |
Primary outcome
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.
3 secondary outcomes
cerebral blood flow
Time frame: 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)
Metabolic and Ventilatory Variables
Time frame: Two measurements will be taken: one at baseline (second visit) and after 6 weeks of training (third visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.