Expiratory Muscle Training and Trunk Flexion in Parkinson's Disease

NCT06963918 | Not Yet Recruiting

• 1 other identifier: 17/25 S-IV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Expiratory Muscle Strength Training; Forward Trunk Flexion

Outcome Measures

Primary Outcomes (1)

• Change in the forward trunk flexion (FTF) angle

  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 Outcomes (8)

• MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.

  Week 0, week 4, week 8, week 12

• Mini-Balance Evaluation Systems Test (Mini-BESTest)

  Week 0, week 4, week 8, week 12

• Pain Intensity - Numeric Rating Scale

  Week 0, week 4, week 8, week 12

• The Parkinson's Disease Questionnaire (PDQ-39)

  Week 0, week 4, week 8, week 12

• Number of Falls in the Previous Month

  Week 0, week 4, week 8, week 12

Study Arms (1)

Expiratory Muscle Strength Training

EXPERIMENTAL

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

Interventions

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.

Expiratory Muscle Strength Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, Czechia

Location

Related Publications (6)

• Chino K, Ohya T, Suzuki Y. Association between expiratory mouth pressure and abdominal muscle activity in healthy young males. Eur J Appl Physiol. 2024 Jul;124(7):2139-2151. doi: 10.1007/s00421-024-05430-5. Epub 2024 Mar 1.

  PMID: 38427101 BACKGROUND

• Puntumetakul R, Chalermsan R, Hlaing SS, Tapanya W, Saiklang P, Boucaut R. The effect of core stabilization exercise on lumbar joint position sense in patients with subacute non-specific low back pain: a randomized controlled trial. J Phys Ther Sci. 2018 Nov;30(11):1390-1395. doi: 10.1589/jpts.30.1390. Epub 2018 Nov 6.

  PMID: 30464372 BACKGROUND

• Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.

  PMID: 34847915 BACKGROUND

• Szczygiel E, Blaut J, Zielonka-Pycka K, Tomaszewski K, Golec J, Czechowska D, Maslon A, Golec E. The Impact of Deep Muscle Training on the Quality of Posture and Breathing. J Mot Behav. 2018 Mar-Apr;50(2):219-227. doi: 10.1080/00222895.2017.1327413. Epub 2017 Aug 18.

  PMID: 28820662 BACKGROUND

• Gandolfi M, Geroin C, Imbalzano G, Camozzi S, Menaspa Z, Tinazzi M, Alberto Artusi C. Treatment of axial postural abnormalities in parkinsonism disorders: A systematic review of pharmacological, rehabilitative and surgical interventions. Clin Park Relat Disord. 2024 Mar 12;10:100240. doi: 10.1016/j.prdoa.2024.100240. eCollection 2024.

  PMID: 38596537 BACKGROUND

• Artusi CA, Geroin C, Imbalzano G, Camozzi S, Aldegheri S, Lopiano L, Tinazzi M, Bombieri N. Assessment of Axial Postural Abnormalities in Parkinsonism: Automatic Picture Analysis Software. Mov Disord Clin Pract. 2023 Feb 20;10(4):636-645. doi: 10.1002/mdc3.13692. eCollection 2023 Apr.

  PMID: 37070056 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kateřina Dvořáková, MSc.

CONTACT

+420 224 965 513; katerina.dvorakova@vfn.cz

Martin Srp, PhD.

CONTACT

+420 224 965 513

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 9, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

CZ (1)