xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017336</url>
    </required_header>
    <id_info>
      <org_study_id>Gazi University 78</org_study_id>
      <nct_id>NCT06017336</nct_id>
    </id_info>
    <brief_title>Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parkinson's patients usually have a significant decrease in respiratory muscle strength and&#xD;
        respiratory function, which may increase in proportion to the severity of the disease. In&#xD;
        addition, peripheral muscles may become dysfunctional by the rigidity caused by the disease.&#xD;
        This reduces exercise capacity and may lead to a decrease in oxygen consumption. Respiratory&#xD;
        muscle training has increased respiratory muscle strength in people with Parkinson's Disease&#xD;
        (PD). However, its effectiveness on other functional outcomes has not been determined and&#xD;
        studied.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Parkinson's disease is the second most common neurodegenerative disease. The main motor&#xD;
        symptoms seen in Parkinson's disease are tremors, rigidity, bradykinesia, and decreased&#xD;
        postural reflexes. In addition, respiratory problems that lead to death may often be seen.&#xD;
        This is caused by dysfunction in the respiratory muscles and postural abnormalities, as well&#xD;
        as changes in upper airway muscle activation and coordination. The coughing or exhaling&#xD;
        reflex requires coordinated motor activity, and inadequate airway defence puts patients at&#xD;
        risk for pneumonia. Aspiration into the lower airways results in a distinct series of events,&#xD;
        including coughing and swallowing as the first attempt to clear the airway. Aspiration&#xD;
        pneumonia is seen in Parkinson's patients because the coordination of these processes is&#xD;
        unsuccessful, and the cough force is insufficient. Upper airway obstruction may occur due to&#xD;
        stiffness and fatigue in the thyroarytenoid muscles. In addition, pathological processes such&#xD;
        as bradykinesia, coordination disorder, and inspiratory muscle weakness can cause&#xD;
        kyphoscoliosis and a decrease in lung volumes, resulting in restrictive respiratory function&#xD;
        abnormality due to decreased chest wall compliance due to rigidity. In Parkinson's disease,&#xD;
        respiratory muscles, like other skeletal muscles, are affected by stiffness, and weakness of&#xD;
        the respiratory muscles makes it difficult to overcome this stiffness, resulting in reduced&#xD;
        lung volumes. It is thought that this condition may develop due to the decrease in elastic&#xD;
        retraction of the chest wall. In addition, mitochondrial dysfunction due to the pathogenesis&#xD;
        of the disease also leads to deterioration in muscle oxygen metabolism. In individuals with&#xD;
        reduced muscle oxygen, exercise tolerance and muscle strength decrease. Autonomic dysfunction&#xD;
        of varying severity is observed in almost all patients, depending on the degeneration of&#xD;
        spinal autonomic neurons or the side effects of dopaminergic that are part of pharmacological&#xD;
        treatment. Patients may experience increased fatigue as well as autonomic dysfunction.&#xD;
        Inadequate oxygen delivery and utilization to the muscles may limit skeletal muscle&#xD;
        oxygenation and lead to increased use of anaerobic systems, resulting in fatigue. This causes&#xD;
        a decrease in the level of physical activity and reduces the quality of life.&#xD;
  &#xD;
        However, studies investigating the effects of inspiratory muscle training in Parkinson's&#xD;
        patients are insufficient. The aim of this study is to investigate the effects of inspiratory&#xD;
        muscle training on maximum and functional exercise capacity, muscle oxygen, peripheral and&#xD;
        respiratory muscle strength, respiratory muscle endurance, respiratory function, dyspnea,&#xD;
        fatigue, cough strength, autonomic dysfunction, physical activity level and quality of life&#xD;
        in patients with Parkinson's disease.For this purpose, our study was planned as a randomized,&#xD;
        controlled, three-blind (investigators, patient, and analyzer) prospective study. According&#xD;
        to the block randomization result, at least 20 patients with a diagnosis of Parkinson's&#xD;
        Disease will be included in the training and control groups.&#xD;
  &#xD;
        Patients in the inspiratory muscle training group will be given inspiratory muscle strength&#xD;
        training with the Powerbreathe device at 50% of the maximal inspiratory pressure for a total&#xD;
        of 8 weeks, for a total of 30 minutes a day. Thoracic expansion exercises will be given to&#xD;
        the control group as a home program for 8 weeks. All assessments will be completed in two&#xD;
        days, before and after eight weeks of training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">February 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 15, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Triple-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Oxygen Consumption</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Cardiopulmonary Exercises Test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Respiratory Muscle Strength</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory Muscle Endurance</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function (Forced vital capacity (FVC)</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function (Forced expiratory volume in the first second (FEV1)</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function (FEV1 / FVC)</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function (Peak flow rate (PEF))</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral Muscle Strength</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Peripheral muscle strength will be evaluated with a dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lower extremity exercise capacity</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Lower extremity exercise capacity will be evaluated with six- minute walking test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Upper extremity exercise capacity</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cough Strength</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Autonomic dysfunction</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>It will be measured by postural change during ECG recording</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue Severity</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Fatigue will be evaluated using the Parkinson Fatigue Scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Life quality</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Health-related quality of life of patients will be evaluated with the Parkinson's Disease Questionnaire-39</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle oxygenation</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Level</measure>
      <time_frame>Trough study completion, an average of 2 year</time_frame>
      <description>A multi-sensor activity monitor will be used to assess the level of physical activity.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Inspiratory Muscle Training Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Control group will be given breathing exercises as a home program for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Inspiratory Muscle Training Group</intervention_name>
      <description>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.</description>
      <arm_group_label>Inspiratory Muscle Training Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Group (breathing exercises)</intervention_name>
      <description>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.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Between the ages of 45-80,&#xD;
  &#xD;
            2. Follow-up with a diagnosis of Parkinson's disease for more than six months&#xD;
  &#xD;
            3. Stages I-III according to the modified Hoehn and Yahr scale&#xD;
  &#xD;
            4. Parkinson's patients with independent walking capacity will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Having a neurological disease other than Parkinson's disease&#xD;
  &#xD;
            2. Patients with a diagnosed lung disease that may affect respiratory functions&#xD;
  &#xD;
            3. At least 10 pack years or more of smoking history&#xD;
  &#xD;
            4. According to the American Association of Sports Medicine (ACSM) with absolute and&#xD;
               relative contraindications to exercise tests&#xD;
  &#xD;
            5. Those with a Mini-Mental State Rating Scale score of less than 18&#xD;
  &#xD;
            6. Patients with additional cardiac orthopaedic and psychological problems that limit the&#xD;
               evaluation will be excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Musa GÜNEŞ, MsC</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hatice Ayşe TOKÇAER BORA, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Meral BOŞNAK GÜÇLÜ, Prof. Dr.</last_name>
      <role>Study Director</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic</name>
        <address>
          <city>Ankara</city>
          <zip>06560</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>29756459</PMID>
    </reference>
    <reference>
      <citation>Reyes 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.</citation>
      <PMID>31155431</PMID>
    </reference>
    <reference>
      <citation>McMahon 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.</citation>
      <PMID>33098349</PMID>
    </reference>
    <reference>
      <citation>Mohammed 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.</citation>
      <PMID>36781936</PMID>
    </reference>
    <reference>
      <citation>Huang 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.</citation>
      <PMID>34744975</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>Meral Boşnak Güçlü</investigator_full_name>
      <investigator_title>Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>Parkinson Disease</keyword>
    <keyword>inspiratory muscle training</keyword>
    <keyword>oxygen consumption</keyword>
    <keyword>physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</mesh_term>
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017336
  org study id: Gazi University 78
  nct id: NCT06017336
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Triple-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.
  measure: Oxygen Consumption
  time frame: Trough study completion, an average of 2 year
  description: Cardiopulmonary Exercises Test
  measure: Respiratory Muscle Strength
  time frame: Trough study completion, an average of 2 year
  description: Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were
  measure: Respiratory Muscle Endurance
  time frame: Trough study completion, an average of 2 year
  description: 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.
  measure: Pulmonary function (Forced vital capacity (FVC)
  time frame: Trough study completion, an average of 2 year
  description: 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.
  measure: Pulmonary function (Forced expiratory volume in the first second (FEV1)
  time frame: Trough study completion, an average of 2 year
  description: 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.
  measure: Pulmonary function (FEV1 / FVC)
  time frame: Trough study completion, an average of 2 year
  description: Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
  measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
  time frame: Trough study completion, an average of 2 year
  description: 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.
  measure: Pulmonary function (Peak flow rate (PEF))
  time frame: Trough study completion, an average of 2 year
  description: 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.
  measure: Peripheral Muscle Strength
  time frame: Trough study completion, an average of 2 year
  description: Peripheral muscle strength will be evaluated with a dynamometer.
  measure: Lower extremity exercise capacity
  time frame: Trough study completion, an average of 2 year
  description: Lower extremity exercise capacity will be evaluated with six- minute walking test.
  measure: Upper extremity exercise capacity
  time frame: Trough study completion, an average of 2 year
  description: Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
  measure: Cough Strength
  time frame: Trough study completion, an average of 2 year
  description: Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).
  measure: Autonomic dysfunction
  time frame: Trough study completion, an average of 2 year
  description: It will be measured by postural change during ECG recording
  measure: Fatigue Severity
  time frame: Trough study completion, an average of 2 year
  description: Fatigue will be evaluated using the Parkinson Fatigue Scale.
  measure: Life quality
  time frame: Trough study completion, an average of 2 year
  description: Health-related quality of life of patients will be evaluated with the Parkinson's Disease Questionnaire-39
  measure: Muscle oxygenation
  time frame: Trough study completion, an average of 2 year
  description: Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
  measure: Physical Activity Level
  time frame: Trough study completion, an average of 2 year
  description: A multi-sensor activity monitor will be used to assess the level of physical activity.
  arm group label: Inspiratory Muscle Training Group
  arm group type: Experimental
  description: 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.
  arm group label: Control Group
  arm group type: Sham Comparator
  description: Control group will be given breathing exercises as a home program for 8 weeks.
  intervention type: Other
  intervention name: Inspiratory Muscle Training Group
  description: 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.
  arm group label: Inspiratory Muscle Training Group
  intervention type: Other
  intervention name: Control Group (breathing exercises)
  description: 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.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Musa GÜNEŞ, MsC
  role: Principal Investigator
  affiliation: Gazi University
  last name: Hatice Ayşe TOKÇAER BORA, Prof. Dr.
  role: Principal Investigator
  affiliation: Gazi University
  last name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
  role: Study Director
  affiliation: Gazi University
  facility: 
  country: Turkey
  citation: 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.
  PMID: 29756459
  citation: Reyes 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.
  PMID: 31155431
  citation: McMahon 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.
  PMID: 33098349
  citation: Mohammed 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.
  PMID: 36781936
  citation: Huang 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.
  PMID: 34744975
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: Meral Boşnak Güçlü
  investigator title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Cardiopulmonary Physiotherapy and Rehabilitation
  mesh term: Respiratory Aspiration
  mesh term: Parkinson Disease
  sharing ipd: No