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

NCT04228887 | Completed

• 1 other identifier: BezmialemVU27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Inspiratory Muscle Training; Balance Training

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Mobility Status- Rivermead mobility index

  Change from baselines to final evaluation at 8th weeks

• Quality of Life Parameter-Nottingham Health Profile

  Change from baselines to final evaluation at 8th weeks

• Activities of Daily Living-Barthel

  Change from baselines to final evaluation at 8th weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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; Device: Balance Training

Training Group

ACTIVE COMPARATOR

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; Device: Balance Training; Device: Inspiratory Muscle Training

Interventions

Respiratory Muscle Strength DIAGNOSTIC_TEST

Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.

Control Group; Training Group

Balance Training DEVICE

Balance training will provide with Biodex® Balance Training System

Control Group; Training Group

Inspiratory Muscle Training DEVICE

15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device

Training Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Parkinson'S Disease
• Ages between 60 and 85 years
• Grades 1 to 3 according to Modified Hoehn-Yahr Scale

You may not qualify if:

• Lung surgery or diagnosed lung disease history
• Dementia
• Having a orthopedic disorder which may affect balance and/or mobility
• Severe dyskinesia and cognition problems

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Hülya N Gürses, Prof

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: January 14, 2020
• Study Start: May 4, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 15, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)