Parkinson DiseaseNCT06017336
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
A study testing Inspiratory Muscle Training Group in people with Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's patients usually have a significant decrease in respiratory muscle strength and respiratory function, which may increase in proportion to the severity of the disease. In addition, peripheral muscles may become dysfunctional by the rigidity caused by the disease. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Inspiratory Muscle Training Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 45-80,
- Follow-up with a diagnosis of Parkinson's disease for more than six months
- Stages I-III according to the modified Hoehn and Yahr scale
- Parkinson's patients with independent walking capacity will be included.
Who cannot join
- Having a neurological disease other than Parkinson's disease
- Patients with a diagnosed lung disease that may affect respiratory functions
- At least 10 pack years or more of smoking history
- According to the American Association of Sports Medicine (ACSM) with absolute and relative contraindications to exercise tests
- Those with a Mini-Mental State Rating Scale score of less than 18
- Patients with additional cardiac orthopaedic and psychological problems that limit the evaluation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Musa GÜNEŞ, MsC contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Ankara, 06560
Meral BOŞNAK GÜÇLÜ, Prof. Dr., +903122162647, meralbosnak@gazi.edu.tr
Musa GÜNEŞ, PT, MsC
About this study
Official title: Investigation of the Effects of Inspiratory Muscle Training on Oxygen Consumption, Muscle Oxygen and Physical Activity Level in Patients With Parkinson's Disease
Parkinson's patients usually have a significant decrease in respiratory muscle strength and respiratory function, which may increase in proportion to the severity of the disease. In addition, peripheral muscles may become dysfunctional by the rigidity caused by the disease. This reduces exercise capacity and may lead to a decrease in oxygen consumption. Respiratory muscle training has increased respiratory muscle strength in people with Parkinson's Disease (PD). However, its effectiveness on other functional outcomes has not been determined and studied.
Read the detailed description
Parkinson's disease is the second most common neurodegenerative disease. The main motor symptoms seen in Parkinson's disease are tremors, rigidity, bradykinesia, and decreased postural reflexes. In addition, respiratory problems that lead to death may often be seen. This is caused by dysfunction in the respiratory muscles and postural abnormalities, as well as changes in upper airway muscle activation and coordination. The coughing or exhaling reflex requires coordinated motor activity, and inadequate airway defence puts patients at risk for pneumonia. Aspiration into the lower airways results in a distinct series of events, including coughing and swallowing as the first attempt to clear the airway. Aspiration pneumonia is seen in Parkinson's patients because the coordination of these processes is unsuccessful, and the cough force is insufficient. Upper airway obstruction may occur due to stiffness and fatigue in the thyroarytenoid muscles. In addition, pathological processes such as bradykinesia, coordination disorder, and inspiratory muscle weakness can cause kyphoscoliosis and a decrease in lung volumes, resulting in restrictive respiratory function abnormality due to decreased chest wall compliance due to rigidity. In Parkinson's disease, respiratory muscles, like other skeletal muscles, are affected by stiffness, and weakness of the respiratory muscles makes it difficult to overcome this stiffness, resulting in reduced lung volumes. It is thought that this condition may develop due to the decrease in elastic retraction of the chest wall. In addition, mitochondrial dysfunction due to the pathogenesis of the disease also leads to deterioration in muscle oxygen metabolism. In individuals with reduced muscle oxygen, exercise tolerance and muscle strength decrease. Autonomic dysfunction of varying severity is observed in almost all patients, depending on the degeneration of spinal autonomic neurons or the side effects of dopaminergic that are part of pharmacological treatment. Patients may experience increased fatigue as well as autonomic dysfunction. Inadequate oxygen delivery and utilization to the muscles may limit skeletal muscle oxygenation and lead to increased use of anaerobic systems, resulting in fatigue. This causes a decrease in the level of physical activity and reduces the quality of life.
However, studies investigating the effects of inspiratory muscle training in Parkinson's patients are insufficient. The aim of this study is to investigate the effects of inspiratory muscle training on maximum and functional exercise capacity, muscle oxygen, peripheral and respiratory muscle strength, respiratory muscle endurance, respiratory function, dyspnea, fatigue, cough strength, autonomic dysfunction, physical activity level and quality of life in patients with Parkinson's disease.For this purpose, our study was planned as a randomized, controlled, three-blind (investigators, patient, and analyzer) prospective study. According to the block randomization result, at least 20 patients with a diagnosis of Parkinson's Disease will be included in the training and control groups.
Patients in the inspiratory muscle training group will be given inspiratory muscle strength training with the Powerbreathe device at 50% of the maximal inspiratory pressure for a total of 8 weeks, for a total of 30 minutes a day. Thoracic expansion exercises will be given to the control group as a home program for 8 weeks. All assessments will be completed in two days, before and after eight weeks of training.
- Conditions
- Parkinson Disease
- Being tested
- Inspiratory Muscle Training Group, Control Group (breathing exercises)
- Keywords
- Parkinson Disease, inspiratory muscle training, oxygen consumption, physical activity
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training GroupOther
Patients in the inspiratory muscle training group will be given inspiratory muscle strength training with the Powerbreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure, 2 sets of 15 minutes a day for a total of 30 min/day or a single set of 30 min/day, 7 days/week for 8 weeks. Patients in the inspiratory muscle training group will continue their respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week. The MIPs of the patients will be re-measured every week and the training workload will be determined at 50% of the new maximal inspiratory pressure.
Control Group (breathing exercises)Other
Thoracic expansion exercises will be given to the control group as a home program. The control group will be asked to do thoracic expansion exercises seven days/week and 120 times/day for eight weeks. The patients in the control group will be called once a week to check their home schedules, and they will be asked to keep a diary.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Patients in the training group will be performed inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure. Receives: Other: Inspiratory Muscle Training Group |
| Control Group | Sham comparator | Control group will be given breathing exercises as a home program for 8 weeks. Receives: Other: Control Group (breathing exercises) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption
Cardiopulmonary Exercises Test
Measured: Trough study completion, an average of 2 year
Secondary outcomes (16)
Respiratory Muscle Strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were
Measured: Trough study completion, an average of 2 year
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load.
Measured: Trough study completion, an average of 2 year
Pulmonary function (Forced vital capacity (FVC)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.
Measured: Trough study completion, an average of 2 year
Pulmonary function (Forced expiratory volume in the first second (FEV1)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.
Measured: Trough study completion, an average of 2 year
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
Measured: Trough study completion, an average of 2 year
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.
Measured: Trough study completion, an average of 2 year
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.
Measured: Trough study completion, an average of 2 year
Peripheral Muscle Strength
Peripheral muscle strength will be evaluated with a dynamometer.
Measured: Trough study completion, an average of 2 year
Lower extremity exercise capacity
Lower extremity exercise capacity will be evaluated with six- minute walking test.
Measured: Trough study completion, an average of 2 year
Upper extremity exercise capacity
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Measured: Trough study completion, an average of 2 year
Cough Strength
Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).
Measured: Trough study completion, an average of 2 year
Autonomic dysfunction
It will be measured by postural change during ECG recording
Measured: Trough study completion, an average of 2 year
Fatigue Severity
Fatigue will be evaluated using the Parkinson Fatigue Scale. Total score varies between 16-80. As the score increases, the severity of fatigue increases.
Measured: Trough study completion, an average of 2 year
Life quality
Patients' health-related quality of life will be evaluated using the Parkinson's disease questionnaire-39. The total score varies between 0-156, and the quality of life worsens as the score increases.
Measured: Trough study completion, an average of 2 year
Muscle oxygenation
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Measured: Trough study completion, an average of 2 year
Physical Activity Level
A multi-sensor activity monitor will be used to assess the level of physical activity.
Measured: Trough study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start15 Aug 2023
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Musa GÜNEŞ, MsC, Principal investigator, Gazi UniversityHatice Ayşe TOKÇAER BORA, Prof. Dr., Principal investigator, Gazi UniversityMeral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017336
- Sponsor's protocol ID
- Gazi University 78
- Status last verified
- Dec 2023
- First submitted
- 15 Aug 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13.
PubMed 29756459Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31.
PubMed 31155431McMahon L, Blake C, Lennon O. Nonpharmacological interventions for respiratory health in Parkinson's disease: A systematic review and meta-analysis. Eur J Neurol. 2021 Mar;28(3):1022-1040. doi: 10.1111/ene.14605. Epub 2020 Dec 1.
PubMed 33098349Mohammed Yusuf SF, Bhise A, Nuhmani S, Alghadir AH, Khan M. Effects of an incentive spirometer versus a threshold inspiratory muscle trainer on lung functions in Parkinson's disease patients: a randomized trial. Sci Rep. 2023 Feb 13;13(1):2516. doi: 10.1038/s41598-023-29534-8.
PubMed 36781936Huang CC, Lai YR, Wu FA, Kuo NY, Cheng BC, Tsai NW, Kung CT, Chiang YF, Lu CH. Detraining Effect on Pulmonary and Cardiovascular Autonomic Function and Functional Outcomes in Patients With Parkinson's Disease After Respiratory Muscle Training: An 18-Month Follow-Up Study. Front Neurol. 2021 Oct 21;12:735847. doi: 10.3389/fneur.2021.735847. eCollection 2021.
PubMed 34744975Gunes M, Bosnak Guclu M, Guvenir A, Tokcaer Bora HA. Effects of inspiratory muscle training on oxygen consumption, muscle oxygen, and physical activity levels in patients with Parkinson's disease. Sci Rep. 2025 Dec 19;16(1):3451. doi: 10.1038/s41598-025-33413-9.
PubMed 41420055Gunes M, Bosnak Guclu M, Guvenir A, Bora Tokcaer A. Effects of inspiratory muscle training on upper and lower extremity functional exercise capacity, muscle oxygen, and cough strength in patients with Parkinson's disease. Physiother Theory Pract. 2026 Jul;42(7):905-918. doi: 10.1080/09593985.2025.2602854. Epub 2025 Dec 14.
PubMed 41392483
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Inspiratory Muscle Training on Oxygen Consumption, Muscle Oxygen and Physical Activity Level in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06017336
- Acronym / sponsor ID
- Gazi University 78
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, inspiratory muscle training, oxygen consumption, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 30 Aug 2023 (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 patients usually have a significant decrease in respiratory muscle strength and respiratory function, which may increase in proportion to the severity of the disease. In addition, peripheral muscles may become dysfunctional by the rigidity caused by the disease. This reduces exercise capacity and may lead to a decrease in oxygen consumption. Respiratory muscle training has increased respiratory muscle strength in people with Parkinson's Disease (PD). However, its effectiveness on other functional outcomes has not been determined and studied.
Detailed description
Parkinson's disease is the second most common neurodegenerative disease. The main motor symptoms seen in Parkinson's disease are tremors, rigidity, bradykinesia, and decreased postural reflexes. In addition, respiratory problems that lead to death may often be seen. This is caused by dysfunction in the respiratory muscles and postural abnormalities, as well as changes in upper airway muscle activation and coordination. The coughing or exhaling reflex requires coordinated motor activity, and inadequate airway defence puts patients at risk for pneumonia. Aspiration into the lower airways results in a distinct series of events, including coughing and swallowing as the first attempt to clear the airway. Aspiration pneumonia is seen in Parkinson's patients because the coordination of these processes is unsuccessful, and the cough force is insufficient. Upper airway obstruction may occur due to stiffness and fatigue in the thyroarytenoid muscles. In addition, pathological processes such as bradykinesia, coordination disorder, and inspiratory muscle weakness can cause kyphoscoliosis and a decrease in lung volumes, resulting in restrictive respiratory function abnormality due to decreased chest wall compliance due to rigidity. In Parkinson's disease, respiratory muscles, like other skeletal muscles, are affected by stiffness, and weakness of the respiratory muscles makes it difficult to overcome this stiffness, resulting in reduced lung volumes. It is thought that this condition may develop due to the decrease in elastic retraction of the chest wall. In addition, mitochondrial dysfunction due to the pathogenesis of the disease also leads to deterioration in muscle oxygen metabolism. In individuals with reduced muscle oxygen, exercise tolerance and muscle strength decrease. Autonomic dysfunction of varying severity is observed in almost all patients, depending on the degeneration of spinal autonomic neurons or the side effects of dopaminergic that are part of pharmacological treatment. Patients may experience increased fatigue as well as autonomic dysfunction. Inadequate oxygen delivery and utilization to the muscles may limit skeletal muscle oxygenation and lead to increased use of anaerobic systems, resulting in fatigue. This causes a decrease in the level of physical activity and reduces the quality of life.
However, studies investigating the effects of inspiratory muscle training in Parkinson's patients are insufficient. The aim of this study is to investigate the effects of inspiratory muscle training on maximum and functional exercise capacity, muscle oxygen, peripheral and respiratory muscle strength, respiratory muscle endurance, respiratory function, dyspnea, fatigue, cough strength, autonomic dysfunction, physical activity level and quality of life in patients with Parkinson's disease.For this purpose, our study was planned as a randomized, controlled, three-blind (investigators, patient, and analyzer) prospective study. According to the block randomization result, at least 20 patients with a diagnosis of Parkinson's Disease will be included in the training and control groups.
Patients in the inspiratory muscle training group will be given inspiratory muscle strength training with the Powerbreathe device at 50% of the maximal inspiratory pressure for a total of 8 weeks, for a total of 30 minutes a day. Thoracic expansion exercises will be given to the control group as a home program for 8 weeks. All assessments will be completed in two days, before and after eight weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Other: Inspiratory Muscle Training GroupPatients in the training group will be performed inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure. |
| Control Group | Sham comparator | Other: Control Group (breathing exercises)Control group will be given breathing exercises as a home program for 8 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 45-80,
- Follow-up with a diagnosis of Parkinson's disease for more than six months
- Stages I-III according to the modified Hoehn and Yahr scale
- Parkinson's patients with independent walking capacity will be included.
Key exclusion criteria (6 listed)
- Having a neurological disease other than Parkinson's disease
- Patients with a diagnosed lung disease that may affect respiratory functions
- At least 10 pack years or more of smoking history
- According to the American Association of Sports Medicine (ACSM) with absolute and relative contraindications to exercise tests
- Those with a Mini-Mental State Rating Scale score of less than 18
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 |
|---|---|---|
| Inspiratory Muscle Training GroupPatients in the inspiratory muscle training group will be given inspiratory muscle strength training with the Powerbreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure, 2 sets of 15 minutes a day for a total of 30 min/day or a single set of 30 min/day, 7 days/week for 8 weeks. Patients in the inspiratory muscle training group will continue their respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week. The MIPs of the patients will be re-measured every week and the training workload will be determined at 50% of the new maximal inspiratory pressure. | Other | Inspiratory Muscle Training Group |
| Control Group (breathing exercises)Thoracic expansion exercises will be given to the control group as a home program. The control group will be asked to do thoracic expansion exercises seven days/week and 120 times/day for eight weeks. The patients in the control group will be called once a week to check their home schedules, and they will be asked to keep a diary. | Other | Control Group |
Primary outcome
Oxygen Consumption
Time frame: Trough study completion, an average of 2 year
Cardiopulmonary Exercises Test
16 secondary outcomes
Respiratory Muscle Strength
Time frame: Trough study completion, an average of 2 year
Respiratory Muscle Endurance
Time frame: Trough study completion, an average of 2 year
Pulmonary function (Forced vital capacity (FVC)
Time frame: Trough study completion, an average of 2 year
Pulmonary function (Forced expiratory volume in the first second (FEV1)
Time frame: Trough study completion, an average of 2 year
Pulmonary function (FEV1 / FVC)
Time frame: Trough study completion, an average of 2 year
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: Trough study completion, an average of 2 year
Pulmonary function (Peak flow rate (PEF))
Time frame: Trough study completion, an average of 2 year
Peripheral Muscle Strength
Time frame: Trough study completion, an average of 2 year
Lower extremity exercise capacity
Time frame: Trough study completion, an average of 2 year
Upper extremity exercise capacity
Time frame: Trough study completion, an average of 2 year
Cough Strength
Time frame: Trough study completion, an average of 2 year
Autonomic dysfunction
Time frame: Trough study completion, an average of 2 year
Fatigue Severity
Time frame: Trough study completion, an average of 2 year
Life quality
Time frame: Trough study completion, an average of 2 year
Muscle oxygenation
Time frame: Trough study completion, an average of 2 year
Physical Activity Level
Time frame: Trough study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 29756459Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13.
- Background: PubMed 31155431Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31.
- Background: PubMed 33098349McMahon L, Blake C, Lennon O. Nonpharmacological interventions for respiratory health in Parkinson's disease: A systematic review and meta-analysis. Eur J Neurol. 2021 Mar;28(3):1022-1040. doi: 10.1111/ene.14605. Epub 2020 Dec 1.
- Background: PubMed 36781936Mohammed Yusuf SF, Bhise A, Nuhmani S, Alghadir AH, Khan M. Effects of an incentive spirometer versus a threshold inspiratory muscle trainer on lung functions in Parkinson's disease patients: a randomized trial. Sci Rep. 2023 Feb 13;13(1):2516. doi: 10.1038/s41598-023-29534-8.
- Background: PubMed 34744975Huang CC, Lai YR, Wu FA, Kuo NY, Cheng BC, Tsai NW, Kung CT, Chiang YF, Lu CH. Detraining Effect on Pulmonary and Cardiovascular Autonomic Function and Functional Outcomes in Patients With Parkinson's Disease After Respiratory Muscle Training: An 18-Month Follow-Up Study. Front Neurol. 2021 Oct 21;12:735847. doi: 10.3389/fneur.2021.735847. eCollection 2021.
- Derived from this study: PubMed 41420055Gunes M, Bosnak Guclu M, Guvenir A, Tokcaer Bora HA. Effects of inspiratory muscle training on oxygen consumption, muscle oxygen, and physical activity levels in patients with Parkinson's disease. Sci Rep. 2025 Dec 19;16(1):3451. doi: 10.1038/s41598-025-33413-9.
- Derived from this study: PubMed 41392483Gunes M, Bosnak Guclu M, Guvenir A, Bora Tokcaer A. Effects of inspiratory muscle training on upper and lower extremity functional exercise capacity, muscle oxygen, and cough strength in patients with Parkinson's disease. Physiother Theory Pract. 2026 Jul;42(7):905-918. doi: 10.1080/09593985.2025.2602854. Epub 2025 Dec 14.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Musa GÜNEŞ, MsC contact
Musa GÜNEŞ, MsC principal investigator
Gazi University
Hatice Ayşe TOKÇAER BORA, Prof. Dr. principal investigator
Gazi University
Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training Group in people with Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meral BOŞNAK GÜÇLÜ, Prof. Dr. (+903122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Consumption (time frame: Trough study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06017336, which also lists 7 linked publications.
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 15 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.