Expiratory Muscle Training and Trunk Flexion in Parkinson's Disease

April 30, 2025 updated by: Kateřina Dvořáková, General University Hospital, Prague

Effect of Expiratory Muscle Strength Training on Forward Trunk Flexion in Parkinson's Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Martin Srp, PhD.
  • Phone Number: +420 224 965 513

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the forward trunk flexion (FTF) angle
Time Frame: Week 0, Week 8, Week 12
Forward trunk flexion will be assessed using standardized postural photographs. Images will be taken with a camera mounted on a tripod positioned 1 meter above the ground and 3 meters from the participant. The participant will stand in tight-fitting clothing at a predefined location in front of a white wall with a calibration pattern. All camera parameters will remain unchanged throughout the study. Photographs will be analyzed using a semi-automated method, and the extent of forward trunk flexion will be classified according to standardized guidelines for axial postural abnormalities in Parkinson's disease.
Week 0, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.
Time Frame: Week 0, week 4, week 8, week 12
This portion of the scale assesses the motor signs of Parkinson´s disease.The maximum total UPDRS score is 272, indicating the worst possible disability from Parkinson's Disease. The minimum total score is 0, indicating no disability from PD. Improvement greater than (-4.9) points or worsening more than (+4.2) points on MDS-UPDRS II+III represent a minimal clinically important difference.
Week 0, week 4, week 8, week 12
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Week 0, week 4, week 8, week 12
The Mini-BESTest is a comprehensive clinical tool designed to assess balance and postural control. The test consists of 14 tasks, comprising a total of 28 items, each rated from 0 to 2, where 0 indicates severe impairment, 1 indicates moderate impairment and 2 stands for normal performance.
Week 0, week 4, week 8, week 12
Pain Intensity - Numeric Rating Scale
Time Frame: Week 0, week 4, week 8, week 12
Self-reported pain intensity on an 11-point scale (0 = no pain, 10 = worst imaginable pain).
Week 0, week 4, week 8, week 12
The Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: Week 0, week 4, week 8, week 12
The 8-item questionnaire assesses quality of life in people with PD. The minimum score is 0, while the maximum is 100. A higher score indicates a lower quality of life.
Week 0, week 4, week 8, week 12
Number of Falls in the Previous Month
Time Frame: Week 0, week 4, week 8, week 12
Self-reported number of falls experienced in the preceding month.
Week 0, week 4, week 8, week 12
Forced expiratory volume (FEV1)
Time Frame: Week 0, week 4, week 8, week 12.
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Week 0, week 4, week 8, week 12.
Forced vital capacity (FVC)
Time Frame: Week 0, week 4, week 8, week 12.
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Week 0, week 4, week 8, week 12.
Peak expiratory flow (PEF)
Time Frame: Week 0, week 4, week 8, week 12.
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Week 0, week 4, week 8, week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/25 S-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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