Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Respiratory Muscle Strength
Balance Training
Inspiratory Muscle Training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Inspiratory Muscle Training, Balance Training
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Parkinson'S Disease
- Ages between 60 and 85 years
- Grades 1 to 3 according to Modified Hoehn-Yahr Scale
Exclusion Criteria:
- Lung surgery or diagnosed lung disease history
- Dementia
- Having a orthopedic disorder which may affect balance and/or mobility
- Severe dyskinesia and cognition problems
Sites / Locations
- Bezmialem Vakif University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Group
Training Group
Arm Description
The control group will be receive 45 minutes training sessions 3 times a week for 8 weeks; 2 days a week for home based balance training and 1 day for supervisory training with Bio-Dex Balance-System ®.
The training group will receive inspiratory muscle training; 15 minutes sessions 5 times a week for 8 weeks in addion to balance training same as control.
Outcomes
Primary Outcome Measures
Inspiratory Muscle Strength
Maximal inspiratory pressure (MIP) is the most widely used measure of respiratory muscle strength in patients with suspected respiratory muscle weakness. It is determined by measuring upper airway pressure (mouth for outpatients and trachea for intubated or tracheostomized patients) during a maximal voluntary inspiratory effort. The measured pressure is a composite of the pressure generated by the inspiratory muscles and the elastic recoil pressure of the lungs and chest wall.
Respiratory Function- Forced Vital Capasity (FVC)
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. FVC can also help doctors assess the progression of lung disease and evaluate the effectiveness of treatment.
Respiratory Function- Forced Expiratory Volume in 1 second
Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function. It is used to:
Diagnose obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). A person who has asthma or COPD has a lower FEV1 result than a healthy person.
See how well medicines used to improve breathing are working. Check if lung disease is getting worse. Decreases in the FEV1 value may mean the lung disease is getting worse.
Respiratory Function- Peak Expiratory Flow
The peak expiratory flow (PEF), also called peak expiratory flow rate (PEFR), is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air.
Postural Control and Balance
Biodex Balance System evaluations
Parkinson's Status- Unified Parkinson's Disease Rating Scale
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The UPDRS scale includes series of ratings for typical Parkinson's symptoms that cover all of the movement hindrances of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews.
Secondary Outcome Measures
Mobility Status- Rivermead mobility index
The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers. The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run 15 items:
14-self-reported items
1 direct observation item Items progress in difficulty Items are coded as either 0 or 1, depending on whether the patient can complete the task according to specific instructions Items receive a score of 0 for a "No" response and 1 for a "Yes" response Total scores are determined by summing the points for all items A maximum of 15 points is possible; higher scores indicate better mobility performance A score of "0" indicates an inability to perform any of the activities on the measure
Quality of Life Parameter-Nottingham Health Profile
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. Breakdown of questionaire
(1) Part I: 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100
energy level (EL): 3
pain (P): 8
emotional reaction (ER): 9
sleep (S): 5
social isolation (SI): 5
physical abilities (PA): 8
Activities of Daily Living-Barthel
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.
Full Information
NCT ID
NCT04228887
First Posted
August 5, 2019
Last Updated
June 17, 2020
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04228887
Brief Title
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
Official Title
Effects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif 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
In this study investigators will examine the effects of inspiratory muscle training and balance training in patients with Parkinson's Disease
Detailed Description
Parkinson's Disease (PD) is the most common type of Parkinsonism and mainly due to degeneration of basal ganglions and substantia nigra occurs. Balance disorders are one of the common problems in patients with Parkinson's disease. These balance disorders; loss of postural reflexes, insufficiency in postural adjustments, rigidity in the trunk and extremities, and many disorders such as akinesia. Because of balance disorders in patients with PD, increase in addiction to daily life activities, causes physical disability. In the case of PD pulmonary problems may be the leading cause of mortality and mortality. Respiratory symptoms in these patients cause problems in weakness, swallowing, coughing, voice and speech functions. When the investigators look at the current literature, the effect of balance and respiration on Parkinson's patients is found to be seperately but their effect on each other is not sufficiently emphasized. For this reason, the researchers' aim to investigate balance and postural control in patients with Parkinson's disease and to increase the strength of respiratory muscles and to improve balance and postural control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Inspiratory Muscle Training, Balance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will be receive 45 minutes training sessions 3 times a week for 8 weeks; 2 days a week for home based balance training and 1 day for supervisory training with Bio-Dex Balance-System ®.
Arm Title
Training Group
Arm Type
Active Comparator
Arm Description
The training group will receive inspiratory muscle training; 15 minutes sessions 5 times a week for 8 weeks in addion to balance training same as control.
Intervention Type
Diagnostic Test
Intervention Name(s)
Respiratory Muscle Strength
Intervention Description
Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.
Intervention Type
Device
Intervention Name(s)
Balance Training
Intervention Description
Balance training will provide with Biodex® Balance Training System
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device
Primary Outcome Measure Information:
Title
Inspiratory Muscle Strength
Description
Maximal inspiratory pressure (MIP) is the most widely used measure of respiratory muscle strength in patients with suspected respiratory muscle weakness. It is determined by measuring upper airway pressure (mouth for outpatients and trachea for intubated or tracheostomized patients) during a maximal voluntary inspiratory effort. The measured pressure is a composite of the pressure generated by the inspiratory muscles and the elastic recoil pressure of the lungs and chest wall.
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Respiratory Function- Forced Vital Capasity (FVC)
Description
Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. FVC can also help doctors assess the progression of lung disease and evaluate the effectiveness of treatment.
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Respiratory Function- Forced Expiratory Volume in 1 second
Description
Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function. It is used to:
Diagnose obstructive lung diseases such as asthma and chronic obstructive pulmonary disease (COPD). A person who has asthma or COPD has a lower FEV1 result than a healthy person.
See how well medicines used to improve breathing are working. Check if lung disease is getting worse. Decreases in the FEV1 value may mean the lung disease is getting worse.
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Respiratory Function- Peak Expiratory Flow
Description
The peak expiratory flow (PEF), also called peak expiratory flow rate (PEFR), is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air.
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Postural Control and Balance
Description
Biodex Balance System evaluations
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Parkinson's Status- Unified Parkinson's Disease Rating Scale
Description
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The UPDRS scale includes series of ratings for typical Parkinson's symptoms that cover all of the movement hindrances of Parkinson's disease. The UPDRS scale consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews.
Time Frame
Change from baselines to final evaluation at 8th weeks
Secondary Outcome Measure Information:
Title
Mobility Status- Rivermead mobility index
Description
The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers. The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run 15 items:
14-self-reported items
1 direct observation item Items progress in difficulty Items are coded as either 0 or 1, depending on whether the patient can complete the task according to specific instructions Items receive a score of 0 for a "No" response and 1 for a "Yes" response Total scores are determined by summing the points for all items A maximum of 15 points is possible; higher scores indicate better mobility performance A score of "0" indicates an inability to perform any of the activities on the measure
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Quality of Life Parameter-Nottingham Health Profile
Description
The Nottingham Health Profile is intended for primary health care, to provide a brief indication of a patient's perceived emotional, social and physical health problems. Breakdown of questionaire
(1) Part I: 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100
energy level (EL): 3
pain (P): 8
emotional reaction (ER): 9
sleep (S): 5
social isolation (SI): 5
physical abilities (PA): 8
Time Frame
Change from baselines to final evaluation at 8th weeks
Title
Activities of Daily Living-Barthel
Description
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.
Time Frame
Change from baselines to final evaluation at 8th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Parkinson'S Disease
Ages between 60 and 85 years
Grades 1 to 3 according to Modified Hoehn-Yahr Scale
Exclusion Criteria:
Lung surgery or diagnosed lung disease history
Dementia
Having a orthopedic disorder which may affect balance and/or mobility
Severe dyskinesia and cognition problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hülya N Gürses, Prof
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease
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