RECRUITING

Combined Respiratory Training in Persons with ALS

Conditions

ALS Respiratory Insufficiency Dysphagia Breathing Swallowing Exercise Bulbar

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combined Respiratory Training to Improve Pulmonary and Cough Function in Persons with ALS

Quick Facts

Study Start:2023-08-22

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05913882

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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).

Inclusion Criteria

Exclusion 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).

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).

Contacts and Locations

Study Contact

Lauren Tabor Gray, PhD

CONTACT

954-262-8963

Lgray1@nova.edu

Donovan Mott

CONTACT

954-203-2829

donovan.mott@nova.edu

Principal Investigator

Magalie Thomas, MBA

STUDY_CHAIR

Nova Southeastern University

Study Locations (Sites)

Nova Southeastern University

Fort Lauderdale, Florida, 33314

United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

Magalie Thomas, MBA, STUDY_CHAIR, Nova Southeastern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-22

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-08-22

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Breathing
Swallowing
Exercise
Bulbar

Additional Relevant MeSH Terms

ALS
Respiratory Insufficiency
Dysphagia