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NCT Number: NCT06473428

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

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.

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Key information

Conditions

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

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory muscle training

Behavioral

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

Expiratory Muscle Training

Behavioral

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

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.

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 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.

  2. Forced Expiratory Volume in One Second (FEV1)

    Time frame: 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.

  3. Maximal Inspiratory Pressure (MIP)

    Time frame: 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.

  4. Maximal Expiratory Pressure (MEP)

    Time frame: 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.

  5. Peak Expiratory Flow Rate (PEFR)

    Time frame: 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.

  6. Maximum Phonation Time

    Time frame: Assessments 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.

  7. Voice Intensity

    Time frame: Assessments 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.

  8. Speech Rate

    Time frame: Assessments 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.

  9. Speech Pauses

    Time frame: Assessments 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.

  10. Voice Loudness

    Time frame: Assessments 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.

  11. Voice Handicap Index (VHI-10)

    Time frame: 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).

Secondary outcomes

  1. Diaphragm Thickness

    Time frame: Measurements 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.

  2. Diaphragm Excursion

    Time frame: Measurements 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SHU-MEI YANG, MD

CONTACT

[email protected]

886-0972653754

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Acronym: IMPROVE-PD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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