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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with cognitive impairment

Patients with respiratory or other neurological diseases

Patients with smoking history

Patients with respiratory complications

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Inspiratory Muscle TrainingExperimental treatment 1 intervention
Group B: Combined Inspiratory and Expiratory Muscle TrainingExperimental treatment 2 interventions
Group C: Placebo-Controlled Expiratory Muscle TrainingPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
2

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.

Time frame
Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
3

Maximal Inspiratory Pressure (MIP)

This measure will assess the maximal inspiratory pressure (MIP) to evaluate the strength of respiratory muscles during inhalation.

Time frame
Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
4

Maximal Expiratory Pressure (MEP)

This measure will assess the maximal expiratory pressure (MEP) to evaluate the strength of respiratory muscles during exhalation.

Time frame
Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).

Secondary outcomes

1

Diaphragm Thickness

This measure will assess diaphragm thickness using ultrasound to evaluate changes in diaphragm function due to the training.

Time frame
Measurements will be taken at baseline (week 0) and after the intervention period (week 8).
2

Diaphragm Excursion

This measure will assess diaphragm excursion using ultrasound to evaluate the movement of the diaphragm during breathing.

Time frame
Measurements will be taken at baseline (week 0) and after the intervention period (week 8).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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