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Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Training Group
Control Group (breathing exercises)
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, inspiratory muscle training, oxygen consumption, physical activity

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory Muscle Training Group

Control Group

Arm 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.

Control group will be given breathing exercises as a home program for 8 weeks.

Outcomes

Primary Outcome Measures

Oxygen Consumption
Cardiopulmonary Exercises Test

Secondary Outcome Measures

Respiratory Muscle Strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were
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.
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.
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.
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.
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.
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.
Peripheral Muscle Strength
Peripheral muscle strength will be evaluated with a dynamometer.
Lower extremity exercise capacity
Lower extremity exercise capacity will be evaluated with six- minute walking test.
Upper extremity exercise capacity
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Cough Strength
Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).
Autonomic dysfunction
It will be measured by postural change during ECG recording
Fatigue Severity
Fatigue will be evaluated using the Parkinson Fatigue Scale.
Life quality
Health-related quality of life of patients will be evaluated with the Parkinson's Disease Questionnaire-39
Muscle oxygenation
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Physical Activity Level
A multi-sensor activity monitor will be used to assess the level of physical activity.

Full Information

First Posted
August 15, 2023
Last Updated
August 29, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT06017336
Brief Title
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, inspiratory muscle training, oxygen consumption, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training Group
Arm Type
Experimental
Arm 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 Title
Control Group
Arm Type
Sham Comparator
Arm Description
Control group will be given breathing exercises as a home program for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training Group
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Control Group (breathing exercises)
Intervention 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.
Primary Outcome Measure Information:
Title
Oxygen Consumption
Description
Cardiopulmonary Exercises Test
Time Frame
Trough study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Respiratory Muscle Strength
Description
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were
Time Frame
Trough study completion, an average of 2 year
Title
Respiratory Muscle Endurance
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.
Time Frame
Trough study completion, an average of 2 year
Title
Pulmonary function (Forced vital capacity (FVC)
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.
Time Frame
Trough study completion, an average of 2 year
Title
Pulmonary function (Forced expiratory volume in the first second (FEV1)
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.
Time Frame
Trough study completion, an average of 2 year
Title
Pulmonary function (FEV1 / FVC)
Description
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
Time Frame
Trough study completion, an average of 2 year
Title
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
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.
Time Frame
Trough study completion, an average of 2 year
Title
Pulmonary function (Peak flow rate (PEF))
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.
Time Frame
Trough study completion, an average of 2 year
Title
Peripheral Muscle Strength
Description
Peripheral muscle strength will be evaluated with a dynamometer.
Time Frame
Trough study completion, an average of 2 year
Title
Lower extremity exercise capacity
Description
Lower extremity exercise capacity will be evaluated with six- minute walking test.
Time Frame
Trough study completion, an average of 2 year
Title
Upper extremity exercise capacity
Description
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).
Time Frame
Trough study completion, an average of 2 year
Title
Cough Strength
Description
Cough strength will be assessed using a peak cough flow meter (PEFmeter) (ExpiRite Peak Flow Meter, China).
Time Frame
Trough study completion, an average of 2 year
Title
Autonomic dysfunction
Description
It will be measured by postural change during ECG recording
Time Frame
Trough study completion, an average of 2 year
Title
Fatigue Severity
Description
Fatigue will be evaluated using the Parkinson Fatigue Scale.
Time Frame
Trough study completion, an average of 2 year
Title
Life quality
Description
Health-related quality of life of patients will be evaluated with the Parkinson's Disease Questionnaire-39
Time Frame
Trough study completion, an average of 2 year
Title
Muscle oxygenation
Description
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).
Time Frame
Trough study completion, an average of 2 year
Title
Physical Activity Level
Description
A multi-sensor activity monitor will be used to assess the level of physical activity.
Time Frame
Trough study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Musa GÜNEŞ, MsC
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hatice Ayşe TOKÇAER BORA, Prof. Dr.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meral BOŞNAK GÜÇLÜ, Prof. Dr.
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
City
Ankara
ZIP/Postal Code
06560
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29756459
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.
Results Reference
background
PubMed Identifier
31155431
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.
Results Reference
background
PubMed Identifier
33098349
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.
Results Reference
background
PubMed Identifier
36781936
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.
Results Reference
background
PubMed Identifier
34744975
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.
Results Reference
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Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease

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