Combined Respiratory Training in Persons With ALS

ConditionsALS Respiratory Insufficiency Dysphagia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-90

SponsorNova Southeastern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

34 Participants

are divided into 1 treatment group

Group A: Lung Volume Recruitment +Expiratory Muscle Strength TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Peak Cough Flow

Greatest cough measurement measured in liters/minute.

Time frame

From Baseline 1 to Final Evaluation (10 weeks)

Secondary outcomes

Cough Spirometry

Airflow parameters will be collected during voluntary cough production. The primary outcome obtained from voluntary cough spirometry will be cough volume acceleration (L/s/s), which is an aggregation of peak expiratory flow rate and peak expiratory rise time.

Time frame

From Baseline 2 to Final Evaluation (5 weeks)

Pulmonary Function Assessment

Vital capacity with and without LVR. Forced vital capacity will be assessed before and after lung volume recruitment and the measurements will be used to determine the difference between FVC and FVC LIC (% predicted age/gender).

Time frame

From Baseline 1 to Final Evaluation (10 weeks)

Pulmonary Function Assessment

Maximum respiratory pressure will be obtained to assess inspiratory and expiratory muscle strength (cmH20).

Time frame

From Baseline 1 to Final evaluation (10 weeks)

Pulmonary Function Assessment

Maximum phonation time involves the participant sustaining the vowel /ah/ for as long as possible (seconds).

Time frame

From Baseline 1 to Final evaluation (10 weeks)

Other outcomes

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

The ALSFRS-R is the validated, gold standard survey assessing ALS symptom and disease progression to determine disease severity ranging from 0 (severe disease symptomology) to 48 (no overt symptoms)

Time frame

From Baseline 1 to Final Evaluation (10 weeks)

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

The CNS-BFS is a 21-item validated, patient-reported scale indexing degree of bulbar dysfunction in the domains of speech, salivation and swallowing.

Time frame

From Baseline 1 to Final Evaluation (10 weeks)