Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease
- Conditions
- Parkinson DiseaseVoice DisordersPulmonary Disease
- Interventions
- Behavioral: respiratory muscle trainingBehavioral: Placebo-Controlled Expiratory Muscle TrainingBehavioral: Expiratory Muscle Training
- Registration Number
- NCT06473428
- Lead Sponsor
- National Taiwan University Hospital
- Brief 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). 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined Inspiratory and Expiratory Muscle Training 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 Combined Inspiratory and Expiratory Muscle Training 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 Inspiratory Muscle Training respiratory 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. Placebo-Controlled Expiratory Muscle Training 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
- Primary Outcome Measures
Name Time Method Peak Expiratory Flow Rate (PEFR) 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.
Forced Vital Capacity (FVC) 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.
Maximal Inspiratory Pressure (MIP) 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.
Speech Rate 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.
Voice Loudness 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.
Forced Expiratory Volume in One Second (FEV1) 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 Expiratory Pressure (MEP) 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.
Maximum Phonation Time 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 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 Pauses 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 Handicap Index (VHI-10) 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).
- Secondary Outcome Measures
Name Time Method Diaphragm Thickness 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.
Diaphragm Excursion 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.