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

NCT06473428 | Not Yet Recruiting

• 1 other identifier: 202306013RINA
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Pulmonary Disease; Voice Disorders

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• 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).

Study Arms (3)

Inspiratory Muscle Training

EXPERIMENTAL

Participants in this group will undergo a specific inspiratory muscle training program. The training consists of two sessions per day, each comprising five repetitions per session. Each repetition will involve a series of inspiratory exercises aimed at strengthening the respiratory muscles. The training will be conducted six days a week for eight weeks.

Behavioral: respiratory muscle training

Combined Inspiratory and Expiratory Muscle Training

EXPERIMENTAL

This group will participate in a combined inspiratory and expiratory muscle training regimen. Similar to the inspiratory group, training sessions will occur twice daily, with each session comprising five repetitions of both inspiratory and expiratory exercises. The training will also be conducted six days a week for eight weeks

Behavioral: respiratory muscle training; Behavioral: Expiratory Muscle Training

Placebo-Controlled Expiratory Muscle Training

PLACEBO COMPARATOR

Participants in this control group will receive placebo-controlled expiratory muscle training. The training sessions will be similar in structure to the experimental groups, consisting of two daily sessions with five repetitions each, conducted six days a week for eight weeks

Behavioral: Placebo-Controlled Expiratory Muscle Training

Interventions

respiratory muscle training BEHAVIORAL

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

Combined Inspiratory and Expiratory Muscle Training; Inspiratory Muscle Training

Expiratory Muscle Training BEHAVIORAL

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

Combined Inspiratory and Expiratory Muscle Training

Placebo-Controlled Expiratory Muscle Training BEHAVIORAL

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

Placebo-Controlled Expiratory Muscle Training

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Lung Diseases; Voice Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Respiratory Tract Diseases; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Shu-mei Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SHU-MEI YANG, MD

CONTACT

886-0972653754; b99401109@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share