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Clinical Trials/NCT06473428
NCT06473428
Not yet recruiting
Not Applicable

The Association of Pulmonary Function, Diaphragm Thickness and Excursion, and Phonatory Measures in Parkinson's Disease

National Taiwan University Hospital0 sites45 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
National Taiwan University Hospital
Enrollment
45
Primary Endpoint
Peak Expiratory Flow Rate (PEFR)
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to investigate the effects of different types of respiratory muscle training on lung function, diaphragm movement, and voice quality in patients with Parkinson's disease (PD). PD often leads to breathing difficulties and voice abnormalities due to weakened respiratory muscles and reduced diaphragm mobility. The study will involve 45 participants with PD, randomly assigned to three groups: one group will perform inspiratory muscle training, the second group will perform both inspiratory and expiratory muscle training, and the third group will receive placebo-controlled expiratory muscle training. The hypothesis is that targeted respiratory muscle training will significantly improve pulmonary function, diaphragm excursion, and phonatory measures compared to the placebo group. The findings aim to develop effective rehabilitation strategies to enhance the quality of life and communication abilities in individuals with PD.

Detailed Description

This study aims to investigate the effects of respiratory muscle training on pulmonary function, diaphragm excursion, and phonatory measures in patients with Parkinson's disease (PD). PD often leads to weakened respiratory muscles, reduced diaphragm movement, and voice abnormalities, impacting breathing and communication. The study will recruit 45 patients with PD, who will be randomly assigned to three groups: an inspiratory muscle training group, a combined inspiratory and expiratory muscle training group, and a placebo-controlled expiratory muscle training group. Over eight weeks, participants will perform daily training sessions, with the intensity of the exercises adjusted periodically. Assessments will include pulmonary function tests, ultrasound measurements of diaphragm thickness and movement, and various phonatory evaluations. The hypothesis is that respiratory muscle training will significantly improve respiratory and phonatory functions in PD patients compared to placebo, providing insights into effective rehabilitation strategies for enhancing their quality of life and communication abilities.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
June 30, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with Parkinson's disease (Hoehn \& Yahr stage I-III),
  • Patients aged 30-85
  • Patients with stable medical condition, regular medication adherence, and ability to follow instructions.

Exclusion Criteria

  • Patients with cognitive impairment
  • Patients with respiratory or other neurological diseases
  • Patients with smoking history
  • Patients with respiratory complications
  • Patients with recent chest/abdominal surgery
  • Patients with clinical instability
  • Patients who are unable to perform pulmonary function tests correctly

Outcomes

Primary Outcomes

Peak Expiratory Flow Rate (PEFR)

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess the peak expiratory flow rate (PEFR) to evaluate participants' lung function.

Forced Vital Capacity (FVC)

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess the forced vital capacity (FVC) to evaluate the maximum amount of air a person can forcibly exhale from the lungs after taking the deepest breath possible.

Maximal Inspiratory Pressure (MIP)

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess the maximal inspiratory pressure (MIP) to evaluate the strength of respiratory muscles during inhalation.

Speech Rate

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess speech rate to evaluate the speed at which a participant speaks.

Voice Loudness

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess voice loudness to evaluate the volume level of a participant's voice.

Forced Expiratory Volume in One Second (FEV1)

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess the forced expiratory volume in one second (FEV1) to evaluate how much air a person can forcibly exhale in one second.

Maximal Expiratory Pressure (MEP)

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess the maximal expiratory pressure (MEP) to evaluate the strength of respiratory muscles during exhalation.

Maximum Phonation Time

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess the maximum phonation time to evaluate the duration a participant can sustain a vowel sound.

Voice Intensity

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess voice intensity to evaluate the loudness of a participant's voice.

Speech Pauses

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess speech pauses to evaluate the frequency and duration of pauses in a participant's speech.

Voice Handicap Index (VHI-10)

Time Frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

This measure will assess vocal performance using the Voice Handicap Index (VHI-10) questionnaire. The VHI-10 scores range from 0 to 40, with higher scores indicating a greater perception of vocal handicap. The score interpretation is as follows: 0-10 (no or minimal handicap), 11-20 (mild handicap), 21-30 (moderate handicap), and 31-40 (severe handicap).

Secondary Outcomes

  • Diaphragm Thickness(Measurements will be taken at baseline (week 0) and after the intervention period (week 8).)
  • Diaphragm Excursion(Measurements will be taken at baseline (week 0) and after the intervention period (week 8).)

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