Trials / Unknown
UnknownNCT04009408
Expiratory Muscle Strength Training (EMST) in Neuromuscular Disorders
Interventional Study of Expiratory Muscle Strength Training as a Treatment in Neuromuscular Disorders
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University of Calgary · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the impact of expiratory muscle strength training (EMST) on the swallowing, breathing, oral intake, quality of life and cough function of people with oculopharyngeal muscular dystrophy (OPMD).
Detailed description
Outline: Twenty participants with OPMD, with dysphagia, will be recruited from Neuromuscular clinics within Calgary. The investigators will enrol patients in a parallel group, sham-controlled, randomized clinical trial, with 10 participants in each group (active EMST and sham EMST). Participants will have baseline measurements of: (i) global swallowing function via modified barium swallow study, (ii) maximum expiratory pressure, (iii) voluntary cough spirometry, (iv) forced vital capacity, (v) functional oral intake, (vi) patient report of self-perceived swallowing impairment (EAT-10 Questionnaire), and (vii) biomarker analyses. Participants will undergo 5-weeks of EMST (active or sham). All baseline measurements will be repeated after 5-weeks of EMST and 10-weeks post-EMST to measure durability of effect. Outcomes: The end-goal of the current research is to obtain preliminary data for the benefit of EMST in a new study population, and direct future studies that may provide evidence for a new standard of care in treating neuromuscular diagnoses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Expiratory muscle strength therapy (EMST150, Aspire LLC) | Active therapy calibrated to the participant's maximum expiratory pressure |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2019-07-05
- Last updated
- 2022-04-21
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04009408. Inclusion in this directory is not an endorsement.