Clinical trial NCT06963918: Expiratory Muscle Training and Trunk Flexion in Parkinson's Disease
Official title: Effect of Expiratory Muscle Strength Training on Forward Trunk Flexion in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Expiratory Muscle Strength Training
Forward Trunk Flexion
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the forward trunk flexion (FTF) angle
timeFrame: Week 0, Week 8, Week 12
Secondary outcomes:
measure: MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.
timeFrame: Week 0, week 4, week 8, week 12
measure: Mini-Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: Week 0, week 4, week 8, week 12
measure: Pain Intensity - Numeric Rating Scale
timeFrame: Week 0, week 4, week 8, week 12
measure: The Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Week 0, week 4, week 8, week 12
measure: Number of Falls in the Previous Month
timeFrame: Week 0, week 4, week 8, week 12
measure: Forced expiratory volume (FEV1)
timeFrame: Week 0, week 4, week 8, week 12.
measure: Forced vital capacity (FVC)
timeFrame: Week 0, week 4, week 8, week 12.
measure: Peak expiratory flow (PEF)
timeFrame: Week 0, week 4, week 8, week 12.
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: General University Hospital
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.