An interventional study of respiratory muscle training and Expiratory Muscle Training in Parkinson Disease, Pulmonary Disease and Voice Disorders, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 45 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
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
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 · Behavioral: 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
Inspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
Expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
Placebo-controlled expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
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).
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).
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).
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).
Peak Expiratory Flow Rate (PEFR)
This measure will assess the peak expiratory flow rate (PEFR) to evaluate participants' lung function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).
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).
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).
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2024; primary completion for Jun 2026, 23 months later.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 23 months is close to that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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