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Behavioural Intervention

Combined Respiratory Training for ALS

N/A

Recruiting

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lung volume recruitment and expiratory muscle strength training naïve

Reduced peak cough flow (% predicted for age and gender)

Must not have

Tracheostomy placement/Use of invasive mechanical ventilation

Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline 1 to final evaluation (10 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how a combination of lung volume recruitment and expiratory muscle strength training can improve cough strength, respiratory function, dyspnea, bulbar impairment, caregiver burden, and quality of life in patients with ALS.

Who is the study for?

This trial is for people with ALS who have had symptoms for less than 2 years, can't already use respiratory training devices, and don't have a tracheostomy or need invasive breathing support. They shouldn't be in other studies that affect coughing or breathing and must not have severe lung diseases like COPD.

What is being tested?

The study tests if combining two types of breathing exercises (LVR+EMST) helps improve cough strength, breath control, swallowing difficulties, and overall quality of life in up to 39 patients with ALS. It also looks at the impact on caregiver burden.

What are the potential side effects?

Potential side effects may include discomfort from the exercises, fatigue due to increased respiratory effort during training sessions, and possible soreness in muscles involved in respiration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never undergone lung volume or expiratory muscle strength training.

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My cough strength is weaker than normal for my age and gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a tracheostomy or use a ventilator to help me breathe.

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I do not have severe lung problems or a history of collapsed lung.

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I use a machine to help with my cough or breathing.

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I have been diagnosed with frontotemporal dementia or severe memory problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline 1 to final evaluation (10 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline 1 to final evaluation (10 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline 1 to final evaluation (10 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Cough Flow

Secondary study objectives

Cough Spirometry

Pulmonary Function Assessment

Other study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung Volume Recruitment +Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met