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NCT Number: NCT06963918

Expiratory Muscle Training and 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Expiratory muscle strength training

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kateřina Dvořáková, MSc.

CONTACT

[email protected]

+420 224 965 513

Martin Srp, PhD.

CONTACT

+420 224 965 513

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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