Combined Respiratory Training in Persons With ALS

NCT05913882 | Recruiting DMC

• 1 other identifier: AL220099
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 1.Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.
2. 2.Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.
3. 3.Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.

Conditions

ALS; Respiratory Insufficiency; Dysphagia

Keywords

Breathing; Swallowing; Exercise; Bulbar

Outcome Measures

Primary Outcomes (1)

• Peak Cough Flow

  Greatest cough measurement measured in liters/minute.

  From Baseline 1 to Final Evaluation (10 weeks)

Secondary Outcomes (4)

• Cough Spirometry

  From Baseline 2 to Final Evaluation (5 weeks)

• Pulmonary Function Assessment

  From Baseline 1 to Final Evaluation (10 weeks)

• Pulmonary Function Assessment

  From Baseline 1 to Final evaluation (10 weeks)

• Pulmonary Function Assessment

  From Baseline 1 to Final evaluation (10 weeks)

Other Outcomes (2)

• ALS Functional Rating Scale-Revised (ALSFRS-R, Cedarbaum et al., 2011)

  From Baseline 1 to Final Evaluation (10 weeks)

• Center for Neurological Study-Bulbar Function Scale (CNS-BFS, Smith et al., 2011)

  From Baseline 1 to Final Evaluation (10 weeks)

Study Arms (1)

Lung Volume Recruitment +Expiratory Muscle Strength Training

EXPERIMENTAL

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.

Device: Respiratory Muscle Strength Training (LVR+EMST)

Interventions

Respiratory Muscle Strength Training (LVR+EMST) DEVICE

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

Lung Volume Recruitment +Expiratory Muscle Strength Training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nova Southeastern University: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

RECRUITING

Related Links

• Nova ALS Clinic

MeSH Terms

Conditions

Respiratory Insufficiency; Deglutition Disorders; Respiratory Aspiration; Motor Activity

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Magalie Thomas, MBA

  Nova Southeastern University

  STUDY CHAIR

Central Study Contacts

Lauren Tabor Gray, PhD

CONTACT

954-262-8963; Lgray1@nova.edu

Donovan Mott

CONTACT

954-203-2829; donovan.mott@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 22, 2023
• Study Start: August 22, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following close out of study.
• Access Criteria: Please contact the PI Dr Lauren Tabor Gray at Lgray1@nova.edu

Locations

US (1)