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Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06473428
Acronym
IMPROVE-PD
Enrollment
45
Registered
2024-06-25
Start date
2024-07-01
Completion date
2027-06-30
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Pulmonary Disease, Voice Disorders

Keywords

Parkinson's disease, Pulmonary function, Respiratory muscle training, Diaphragm

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.

Interventions

BEHAVIORALrespiratory muscle training

Inspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.

Expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.

BEHAVIORALPlacebo-Controlled Expiratory Muscle Training

Placebo-controlled expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Voice Handicap Index (VHI-10)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).
Speech PausesAssessments 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 LoudnessAssessments 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 Vital Capacity (FVC)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.
Forced Expiratory Volume in One Second (FEV1)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 Inspiratory Pressure (MIP)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.
Maximal Expiratory Pressure (MEP)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.
Peak Expiratory Flow Rate (PEFR)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.
Maximum Phonation TimeAssessments 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 IntensityAssessments 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 RateAssessments 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.

Secondary

MeasureTime frameDescription
Diaphragm ExcursionMeasurements will be taken at baseline (week 0) and after the intervention period (week 8).This measure will assess diaphragm excursion using ultrasound to evaluate the movement of the diaphragm during breathing.
Diaphragm ThicknessMeasurements will be taken at baseline (week 0) and after the intervention period (week 8).This measure will assess diaphragm thickness using ultrasound to evaluate changes in diaphragm function due to the training.

Contacts

Primary ContactSHU-MEI YANG, MD
b99401109@gmail.com886-0972653754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026