Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease (IMPROVE-PD)

June 18, 2024 updated by: National Taiwan University Hospital

The Association of Pulmonary Function, Diaphragm Thickness and Excursion, and Phonatory Measures 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inspiratory Muscle Training
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
Inspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
Experimental: Combined Inspiratory and Expiratory Muscle Training
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
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.
Placebo Comparator: Placebo-Controlled Expiratory Muscle Training
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
Placebo-controlled expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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).
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)
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.
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).
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)
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.
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).
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
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.
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).
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
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.
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).
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)
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).
Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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).
This measure will assess diaphragm excursion using ultrasound to evaluate the movement of the diaphragm during breathing.
Measurements will be taken at baseline (week 0) and after the intervention period (week 8).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shu-mei Yang, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202306013RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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