Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease
NCT Number: NCT06473428
Acronym: IMPROVE-PD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Pulmonary Disease|Voice Disorders
Interventions: BEHAVIORAL: respiratory muscle training|BEHAVIORAL: Expiratory Muscle Training|BEHAVIORAL: Placebo-Controlled Expiratory Muscle Training
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-06-30

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.

Primary Outcome Measures: Forced Vital Capacity (FVC), 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., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Forced Expiratory Volume in One Second (FEV1), 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., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Maximal Inspiratory Pressure (MIP), This measure will assess the maximal inspiratory pressure (MIP) to evaluate the strength of respiratory muscles during inhalation., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Maximal Expiratory Pressure (MEP), This measure will assess the maximal expiratory pressure (MEP) to evaluate the strength of respiratory muscles during exhalation., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Peak Expiratory Flow Rate (PEFR), This measure will assess the peak expiratory flow rate (PEFR) to evaluate participants' lung function., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Maximum Phonation Time, This measure will assess the maximum phonation time to evaluate the duration a participant can sustain a vowel sound., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Voice Intensity, This measure will assess voice intensity to evaluate the loudness of a participant's voice., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Speech Rate, This measure will assess speech rate to evaluate the speed at which a participant speaks., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Speech Pauses, This measure will assess speech pauses to evaluate the frequency and duration of pauses in a participant's speech., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Voice Loudness, This measure will assess voice loudness to evaluate the volume level of a participant's voice., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).|Voice Handicap Index (VHI-10), 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)., Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
Secondary Outcome Measures: Diaphragm Thickness, This measure will assess diaphragm thickness using ultrasound to evaluate changes in diaphragm function due to the training., Measurements will be taken at baseline (week 0) and after the intervention period (week 8).|Diaphragm Excursion, This measure will assess diaphragm excursion using ultrasound to evaluate the movement of the diaphragm during breathing., Measurements will be taken at baseline (week 0) and after the intervention period (week 8).