Parkinson DiseaseNCT06963918
Expiratory Muscle Training and Trunk Flexion in Parkinson's Disease
A study testing Expiratory muscle strength training in people with Parkinson Disease, run by General University Hospital, Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Expiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- Aug 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Srp, PhD. contact
Czechia1 site
General University Hospital
Prague
Kateřina Dvořáková, MSc., +420 224 965 513, katerina.dvorakova@vfn.cz
About this study
Official title: 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.
Read more
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
- Being tested
- Expiratory muscle strength training
- Keywords
- Parkinson Disease, Expiratory Muscle Strength Training, Forward Trunk Flexion
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle strength trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Expiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 8, Week 12
Secondary outcomes (8)
MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.
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.
Measured: Week 0, week 4, week 8, week 12
Mini-Balance Evaluation Systems Test (Mini-BESTest)
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.
Measured: Week 0, week 4, week 8, week 12
Pain Intensity - Numeric Rating Scale
Self-reported pain intensity on an 11-point scale (0 = no pain, 10 = worst imaginable pain).
Measured: Week 0, week 4, week 8, week 12
The Parkinson's Disease Questionnaire (PDQ-39)
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.
Measured: Week 0, week 4, week 8, week 12
Number of Falls in the Previous Month
Self-reported number of falls experienced in the preceding month.
Measured: Week 0, week 4, week 8, week 12
Forced expiratory volume (FEV1)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: Week 0, week 4, week 8, week 12.
Forced vital capacity (FVC)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: Week 0, week 4, week 8, week 12.
Peak expiratory flow (PEF)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Measured: Week 0, week 4, week 8, week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startAug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateřina Dvořáková, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963918
- Sponsor's protocol ID
- 17/25 S-IV
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38427101Puntumetakul 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.
PubMed 30464372Hlaing 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.
PubMed 34847915Szczygiel 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.
PubMed 28820662Gandolfi 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.
PubMed 38596537Artusi 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.
PubMed 37070056
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Expiratory Muscle Strength Training on Forward Trunk Flexion in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06963918
- Acronym / sponsor ID
- 17/25 S-IV
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Expiratory Muscle Strength Training, Forward Trunk Flexion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Strength Training | Experimental | Device: Expiratory muscle strength trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory muscle strength trainingAfter 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. | Device | Expiratory Muscle Strength Training |
Primary outcome
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.
8 secondary outcomes
MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.
Time frame: 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
Pain Intensity - Numeric Rating Scale
Time frame: 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
Number of Falls in the Previous Month
Time frame: Week 0, week 4, week 8, week 12
Forced expiratory volume (FEV1)
Time frame: Week 0, week 4, week 8, week 12.
Forced vital capacity (FVC)
Time frame: Week 0, week 4, week 8, week 12.
Peak expiratory flow (PEF)
Time frame: Week 0, week 4, week 8, week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 38427101Chino 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.
- Background: PubMed 30464372Puntumetakul 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.
- Background: PubMed 34847915Hlaing 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.
- Background: PubMed 28820662Szczygiel 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.
- Background: PubMed 38596537Gandolfi 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.
- Background: PubMed 37070056Artusi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Srp, PhD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle strength training in people with Parkinson Disease, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kateřina Dvořáková, MSc. (+420 224 965 513, katerina.dvorakova@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the forward trunk flexion (FTF) angle (time frame: Week 0, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06963918, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.