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Not yet recruiting NCT06473428

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

No phase Interventional Parkinson Disease Pulmonary Disease Voice Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: respiratory muscle training, Expiratory Muscle Training, Placebo-Controlled Expiratory Muscle Training.
Who it may be relevant to
Registry conditions: Parkinson Disease, Pulmonary Disease, Voice Disorders. Basic parameters: 30 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Behavioral respiratory muscle training
    Inspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
  • Behavioral Expiratory Muscle Training
    Expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
  • Behavioral Placebo-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.

Primary outcome measures

  • Forced Vital Capacity (FVC) [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Forced Expiratory Volume in One Second (FEV1) [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Maximal Inspiratory Pressure (MIP) [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Maximal Expiratory Pressure (MEP) [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Peak Expiratory Flow Rate (PEFR) [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Maximum Phonation Time [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Voice Intensity [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Speech Rate [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Speech Pauses [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Voice Loudness [Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
Secondary outcome measures (2)
  • Diaphragm Thickness [Time frame: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).]
  • Diaphragm Excursion [Time frame: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 30223711
  • 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. PMID 31576908
  • 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. PMID 31000398
  • 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. PMID 29756459
  • 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. PMID 31155431

Identifiers

NCT: NCT06473428 · 202306013RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗