Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease (IMPROVE-PD)

National Taiwan University

Status: Not yet enrolling

Conditions: Voice Disorders; Parkinson Disease; Pulmonary Disease

Treatments: Behavioral: respiratory muscle training; Behavioral: Placebo-Controlled Expiratory Muscle Training; Behavioral: Expiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06473428

202306013RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

Inspiratory Muscle Training

Experimental group

Description:

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.

Treatment:

Behavioral: respiratory muscle training

Combined Inspiratory and Expiratory Muscle Training

Experimental group

Description:

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

Treatment:

Behavioral: Expiratory Muscle Training

Behavioral: respiratory muscle training

Placebo-Controlled Expiratory Muscle Training

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo-Controlled Expiratory Muscle Training