Combined Respiratory Training in Persons With ALS

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
Nova Southeastern University
Study ID
NCT05913882
Status
Recruiting
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Conditions

  • ALS
  • Dysphagia
  • Respiratory Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Respiratory Muscle Strength Training (LVR+EMST) — DEVICE
    Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks.

Study Details

The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed: 1. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS. 2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment. 3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.

Key Dates

Start date
Aug 22, 2023
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lung Volume Recruitment +Expiratory Muscle Strength Training
    All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen following a 5-week no-intervention lead-in period.

Primary Outcome Measure

Peak Cough Flow [ Time Frame: From Baseline 1 to Final Evaluation (10 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nova Southeastern UniversityFort LauderdaleFlorida33314
Lauren Tabor Gray, PhD
[email protected]
954 262 6387
Donovan Mott
[email protected]
954-203-2829

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By research site
Nova Southeastern University· Fort Lauderdale, FL

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