Clinical trial NCT06473428: Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease
Official title: The Association of Pulmonary Function, Diaphragm Thickness and Excursion, and Phonatory Measures in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Pulmonary Disease
Voice Disorders
Keywords: Parkinson's disease
Pulmonary function
Respiratory muscle training
Diaphragm
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Maximal Expiratory Pressure (MEP)
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Peak Expiratory Flow Rate (PEFR)
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Maximum Phonation Time
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Voice Intensity
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Speech Rate
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Speech Pauses
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Voice Loudness
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
measure: Voice Handicap Index (VHI-10)
timeFrame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
Secondary outcomes:
measure: Diaphragm Thickness
timeFrame: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).
measure: Diaphragm Excursion
timeFrame: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Shu-mei Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dashtipour K, Tafreshi A, Lee J, Crawley B. Speech disorders in Parkinson's disease: pathophysiology, medical management and surgical approaches. Neurodegener Dis Manag. 2018 Oct;8(5):337-348. doi: 10.2217/nmt-2018-0021. Epub 2018 Sep 18.
citation: Santos RBD, Fraga AS, Coriolano MDGWS, Tiburtino BF, Lins OG, Esteves ACF, Asano NMJ. Respiratory muscle strength and lung function in the stages of Parkinson's disease. J Bras Pneumol. 2019 Sep 30;45(6):e20180148. doi: 10.1590/1806-3713/e20180148. eCollection 2019.
citation: Castillo A, Castillo J, Reyes A. Association Between Subglottic Pressure and Pulmonary Function in Individuals With Parkinson's Disease. J Voice. 2020 Sep;34(5):732-737. doi: 10.1016/j.jvoice.2019.03.001. Epub 2019 Apr 16.
citation: Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13.
citation: Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31.