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

NCT ID: NCT06473428

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Parkinson Disease Pulmonary Disease Voice Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

respiratory muscle training

Intervention Type 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

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

Group Type EXPERIMENTAL

respiratory muscle training

Intervention Type BEHAVIORAL

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

Expiratory Muscle Training

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo-Controlled Expiratory Muscle Training

Intervention Type BEHAVIORAL

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

Interventions

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respiratory muscle training

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

Intervention Type BEHAVIORAL

Expiratory Muscle Training

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu-mei Yang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

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SHU-MEI YANG, MD

Role: CONTACT

886-0972653754

References

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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.

Reference Type BACKGROUND
PMID: 30223711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31576908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31000398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29756459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31155431 (View on PubMed)

Other Identifiers

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202306013RINA

Identifier Type: -

Identifier Source: org_study_id

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