Parkinson DiseaseIMPROVE-PDNCT06473428
Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease
A study testing respiratory muscle training and Expiratory Muscle Training in people with Parkinson Disease and Pulmonary Disease, run by National Taiwan University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease, Pulmonary Disease, Voice Disorders
- What is being tested?
- respiratory muscle training and Expiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Pulmonary Disease, Voice Disorders
- Being tested
- respiratory muscle training, Expiratory Muscle Training, Placebo-Controlled Expiratory Muscle Training
- Keywords
- Parkinson's disease, Pulmonary function, Respiratory muscle training, Diaphragm
- Medical subject headings
- Parkinson Disease, Lung Diseases, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory muscle trainingBehavioural
Inspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
Expiratory Muscle TrainingBehavioural
Expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
Placebo-Controlled Expiratory Muscle TrainingBehavioural
Placebo-controlled expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Behavioral: Placebo-Controlled Expiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
Secondary outcomes (2)
Diaphragm Thickness
This measure will assess diaphragm thickness using ultrasound to evaluate changes in diaphragm function due to the training.
Measured: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).
Diaphragm Excursion
This measure will assess diaphragm excursion using ultrasound to evaluate the movement of the diaphragm during breathing.
Measured: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-mei Yang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473428
- Sponsor's protocol ID
- 202306013RINA
- Acronym
- IMPROVE-PD
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30223711Santos 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.
PubMed 31576908Castillo 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.
PubMed 31000398Reyes 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.
PubMed 29756459Reyes 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.
PubMed 31155431
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Pulmonary Function, Diaphragm Thickness and Excursion, and Phonatory Measures in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06473428
- Acronym / sponsor ID
- IMPROVE-PD / 202306013RINA
- Conditions
- Parkinson Disease, Pulmonary Disease, Voice Disorders
- Keywords
- Parkinson's disease, Pulmonary function, Respiratory muscle training, Diaphragm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Behavioral: respiratory muscle trainingParticipants 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. |
| Combined Inspiratory and Expiratory Muscle Training | Experimental | Behavioral: respiratory muscle training, Behavioral: Expiratory Muscle TrainingThis 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 |
| Placebo-Controlled Expiratory Muscle Training | Placebo comparator | Behavioral: Placebo-Controlled Expiratory Muscle TrainingParticipants 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 |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| respiratory muscle trainingInspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks. | Behavioural | Combined Inspiratory and Expiratory Muscle Training, Inspiratory Muscle Training |
| Expiratory Muscle TrainingExpiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks. | Behavioural | Combined Inspiratory and Expiratory Muscle Training |
| Placebo-Controlled Expiratory Muscle TrainingPlacebo-controlled expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks. | Behavioural | Placebo-Controlled Expiratory Muscle Training |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 30223711Dashtipour 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.
- Background: PubMed 31576908Santos 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.
- Background: PubMed 31000398Castillo 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.
- Background: PubMed 29756459Reyes 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.
- Background: PubMed 31155431Reyes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shu-mei Yang, MD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing respiratory muscle training and Expiratory Muscle Training in people with Parkinson Disease and Pulmonary Disease, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SHU-MEI YANG, MD (886-0972653754, b99401109@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473428, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.