Expiratory Muscle Training and Trunk Flexion in Parkinson's Disease

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-01-31

Brief Summary

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Postural abnormalities involving the trunk are prevalent in over 20% of patients with Parkinson's disease (PD). Pathological forward trunk flexion (FTF) is a drug-refractory complication in patients with PD leading to imbalance, pain and fall-related injuries. Deep abdominal muscle training is a key rehabilitation strategy for FTF, as muscles like the transversus abdominis and multifidus are crucial for lumbar stabilization. This training has been shown to improve body position and lumbar proprioception.

Abdominal muscles are also responsible for forced expiration. Expiratory muscle strength training (EMST) utilizing forced expiration through expiratory trainer has emerged as a beneficial intervention in the non-pharmacological management of PD, positively impacting clinical aspects such as dysphagia, dystussia, hypokinetic dysarthria, and drooling. EMG study showed large abdominal muscles activity, particularly the transversus abdominis and internus obliquus abdominis during EMST. Therefore, EMST might also be effective in improving lumbar stabilization.

Given the established role of abdominal muscles in trunk stabilization, it is plausible that activation of deep abdominal muscles during EMST with the right level of resistance might improve FTF in PD patients. No studies have yet examined the effect of EMST on posture in PD.

The primary aim of this study will be to evaluate the effect of EMST on forward trunk flexion in patients with Parkinson's disease.

The secondary aim will be to assess the potential duration of the EMST effect on postural abnormalities and its impact on patient stability.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Expiratory Muscle Strength Training

The experimental group will first undergo a 4-week wait-to-start period, then participate in a 4-week expiratory muscle strength training program, followed by a 4-week follow-up phase.

Group Type EXPERIMENTAL

Expiratory muscle strength training

Intervention Type DEVICE

After the 4-week wait-to-start period during which they will not receive any intervention, will participants undergo a 4-week respiratory training program using the EMST150™ device (Expiratory Muscle Strength Trainer). EMST therapy sessions will be completed at home on 5 days (of the patients choosing) per week, performing five sets of five forceful exhalations through the EMST150™. The resistance of the device will be set to 75% of the patient's individual maximum expiratory pressure (MEP). The daily training will take approximately 15 minutes. Following the training period, patients will be observed for an additional 4 weeks to assess the sustainability of the potential training effects.

Interventions

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Expiratory muscle strength training

After the 4-week wait-to-start period during which they will not receive any intervention, will participants undergo a 4-week respiratory training program using the EMST150™ device (Expiratory Muscle Strength Trainer). EMST therapy sessions will be completed at home on 5 days (of the patients choosing) per week, performing five sets of five forceful exhalations through the EMST150™. The resistance of the device will be set to 75% of the patient's individual maximum expiratory pressure (MEP). The daily training will take approximately 15 minutes. Following the training period, patients will be observed for an additional 4 weeks to assess the sustainability of the potential training effects.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Parkinson's Disease
* Age ≥ 18 years
* MoCA (Montreal Cognitive Assessment) score ≥19
* Pathological forward trunk flexion defined as thoracic (≥25°) or lumbar (\>15°) flexion during standing and walking, which completely disappears in the supine position.

Exclusion Criteria

* Severe dyskinesia or "on-off" fluctuations
* Change in the PD medication in the last 3 months prior to enrollment
* History of major spinal surgery or musculoskeletal spinal disorders
* Need for assistive devices when rising from a chair or bed
* Other neurological, orthopedic, or cardiovascular comorbidities that could affect postural control
* Inadequate lip seal.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No