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

Overview

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.

Interventions

• 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

Primary outcome measures

• Change in the forward trunk flexion (FTF) angle [Time frame: Week 0, Week 8, Week 12]

Secondary outcome measures (8)

• 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Czechia · 1 center

• General University Hospital — Prague

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. PMID 38427101
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06963918 · 17/25 S-IV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗