Recruiting

Respiratory Training

Sponsor:

Nova Southeastern University

Code:

NCT05913882

Conditions

ALS

Respiratory Insufficiency

Dysphagia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Respiratory Muscle Strength Training (LVR+EMST)

Study Details

Brief summary:

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.

Conditions

ALS

Respiratory Insufficiency

Dysphagia

Study ID

NCT05913882

Start date

Aug 22, 2023

Status verified date

Dec, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria.
2. Disease duration from symptom onset of ≤ 2 years,
3. Lung volume recruitment and expiratory muscle strength training naïve,
4. Reduced peak cough flow (% predicted for age and gender).

Exclusion Criteria:

1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment.
2. Use of prescription cough assist or non-invasive volume ventilation devices.
3. Enrollment in another research investigation that might impact cough or respiratory function.
4. Diagnosis of frontotemporal dementia or advanced cognitive impairment.
5. Tracheostomy placement/Use of invasive mechanical ventilation.
6. Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).

Study Design

Enrollment

34 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Respiratory Muscle Strength Training (LVR+EMST)

Combined respiratory muscle strength training regimen that will be completed daily for 5 weeks.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Nova Southeastern University

Recruiting

Fort Lauderdale, Florida, United States, 33314

Contacts

More Information

Sponsor

Nova Southeastern University

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • Breathing
  • Swallowing
  • Exercise
  • Bulbar

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2025-12-23.