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

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

In this study investigators will examine the effects of inspiratory muscle training and balance training in patients with Parkinson's Disease

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Diagnostic test: Respiratory Muscle Strength; Device: Balance Training; Device: Inspiratory Muscle Training

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group; 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 ®.	Diagnostic test: Respiratory Muscle Strength; Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.; Device: Balance Training; Balance training will provide with Biodex® Balance Training System
ACTIVE_COMPARATOR: Training Group; 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.	Diagnostic test: Respiratory Muscle Strength; Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.; Device: Balance Training; Balance training will provide with Biodex® Balance Training System; Device: Inspiratory Muscle Training; 15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baselines to final evaluation at 8th weeks
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.	Change from baselines to final evaluation at 8th weeks
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.	Change from baselines to final evaluation at 8th weeks
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.	Change from baselines to final evaluation at 8th weeks
Postural Control and Balance	Biodex Balance System evaluations	Change from baselines to final evaluation at 8th weeks
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.	Change from baselines to final evaluation at 8th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baselines to final evaluation at 8th weeks
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	Change from baselines to final evaluation at 8th weeks
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.	Change from baselines to final evaluation at 8th weeks

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Director: Hülya N Gürses, Prof, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2018
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Inspiratory Muscle Training; Balance Training
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Respiratory Aspiration
• Other Study ID Numbers: BezmialemVU27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No