Combined Respiratory Training for ALS

Overseen By Donovan Mott

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Stroke, Head and neck cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

34 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using prescription cough assist or non-invasive volume ventilation devices, you cannot participate in the trial.

What data supports the effectiveness of the treatment Combined Respiratory Training for ALS?

Research shows that lung volume recruitment (a technique to help with breathing) can improve coughing and lung function in ALS patients. Additionally, a case study found that respiratory strength training improved breathing muscle strength and cough flow in an ALS patient over two years. ^{1 2 3 4 5}

Is Combined Respiratory Training safe for humans?

Research on Combined Respiratory Training, including techniques like Lung Volume Recruitment and Expiratory Muscle Strength Training, has been conducted in people with ALS and shows positive effects on breathing and coughing without significant safety concerns reported. ^{1 3 6 7 8}

How does the Combined Respiratory Training treatment for ALS differ from other treatments?

Combined Respiratory Training for ALS is unique because it combines Lung Volume Recruitment (a technique to improve lung capacity and coughing) and Expiratory Muscle Strength Training (a method to enhance breathing muscle strength), which together aim to improve respiratory function and cough effectiveness in ALS patients, unlike standard treatments that may not address these specific aspects. ^{1 3 7 9 10}

Research Team

Magalie Thomas, MBA

Principal Investigator

Nova Southeastern University

Eligibility Criteria

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.

Inclusion Criteria

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

My symptoms started less than 2 years ago.

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

Exclusion Criteria

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

I am not part of another study that could affect my cough or breathing.

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

Timeline

Screening/Baseline 1

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline 2

Introduction of LVR and EMST training with initial training session

1 week

1 visit (in-person)

Active Training

Weekly telehealth therapy sessions including LVR and EMST training, peak cough flow assessment, and patient-reported outcomes

5 weeks

4 visits (virtual)

Final Evaluation

Final assessment procedures identical to Baseline 2

1 week

1 visit (in-person)

Follow-up

Monthly telehealth visits for peak cough flow and maximum phonation time assessments, and clinician-administered surveys

6 months

6 visits (virtual)

Treatment Details

Interventions

• Combined Respiratory Training

Trial Overview 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.

Participant Groups

Group I: Lung Volume Recruitment +Expiratory Muscle Strength Training Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Findings from Research

A 12-week respiratory strength training (RST) program significantly improved maximum expiratory pressure (MEP) in individuals with early-stage amyotrophic lateral sclerosis (ALS), with an average increase of 20.8 cm H2O, indicating enhanced breathing capacity.

The RST program was well tolerated with a 91% completion rate and no adverse events, and it showed a slower rate of bulbar decline over one year compared to sham training, suggesting potential long-term benefits for airway clearance and respiratory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Strength Training in Amyotrophic Lateral Sclerosis: A Double-Blind, Randomized, Multicenter, Sham-Controlled Trial. Plowman, EK., Gray, LT., Chapin, J., et al.[2023]

In a study of 40 ALS patients, both the breath-stacking technique and mechanical insufflator-exsufflator (MI-E) showed similar rates of chest infections and hospitalization, indicating comparable safety profiles for these cough augmentation methods.

Although there were no statistically significant differences in outcomes, the breath-stacking technique is recommended as a low-cost first-line intervention for cough support in ALS patients, pending further research to confirm its efficacy compared to MI-E.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary randomized trial of the mechanical insufflator-exsufflator versus breath-stacking technique in patients with amyotrophic lateral sclerosis. Rafiq, MK., Bradburn, M., Proctor, AR., et al.[2017]

Lung volume recruitment (LVR) significantly improved forced vital capacity (FVC) for up to 15 minutes after treatment in 29 individuals with amyotrophic lateral sclerosis (ALS), indicating a temporary enhancement in pulmonary function.

LVR also positively affected peak cough flow (PCF) during unassisted coughing at both 15 and 30 minutes post-treatment, suggesting it may help improve coughing effectiveness in ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lung volume recruitment on coughing and pulmonary function in patients with ALS. Cleary, S., Misiaszek, JE., Kalra, S., et al.[2015]

A 24-month respiratory strength training program significantly improved inspiratory and expiratory muscle strength in a patient with C9orf72 amyotrophic lateral sclerosis (ALS), with maximum inspiratory pressure increasing from 71 to 134 cmH2O and maximum expiratory pressure from 108 to 197 cmH2O.

The training also enhanced peak cough flow from 331 to 655 liters per minute, indicating improved respiratory function, while forced vital capacity remained stable, suggesting that early intervention can positively impact respiratory health in ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined respiratory training in an individual with C9orf72 amyotrophic lateral sclerosis. Robison, R., Tabor-Gray, LC., Wymer, JP., et al.[2019]

Expiratory muscle strength training (EMST) was found to be feasible and well tolerated in 25 ALS patients, leading to significant improvements in maximum expiratory pressure and swallowing function after a 5-week training period.

While EMST improved respiratory strength and swallowing mechanics, it did not show significant effects on cough strength or penetration-aspiration scores, indicating that further research is needed to explore its full benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of expiratory strength training in amyotrophic lateral sclerosis. Plowman, EK., Watts, SA., Tabor, L., et al.[2018]

An 8-week in-home expiratory muscle strength training (EMST) program significantly improved maximum expiratory pressure (MEP) and swallowing function in 48 individuals with amyotrophic lateral sclerosis (ALS), indicating its efficacy in enhancing respiratory and bulbar functions.

The EMST program was well-tolerated, with 96% of participants completing the study, suggesting it is a safe intervention for individuals with ALS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of expiratory strength training in amyotrophic lateral sclerosis: Results of a randomized, sham-controlled trial. Plowman, EK., Tabor-Gray, L., Rosado, KM., et al.[2020]

In a pilot study involving 20 ALS patients, those who used POWERbreathe® inspiratory muscle training alongside usual care showed significant improvements in maximum inspiratory pressure (PImax) and heart rate compared to the control group, indicating enhanced respiratory function.

The experimental group also experienced better quality of life and functionality, as evidenced by increased scores on the ALS Functional Rating Scale, suggesting that inspiratory muscle training could be a beneficial addition to standard care for ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

POWERbreathe® Inspiratory Muscle Training in Amyotrophic Lateral Sclerosis. Vicente-Campos, D., Sanchez-Jorge, S., Chicharro, JL., et al.[2023]

This ongoing randomized controlled trial is investigating whether combining breath stacking with expiratory muscle training (EMT) is more effective than breath stacking alone in improving respiratory muscle strength and function in 42 ALS patients.

The study aims to fill a gap in current research by evaluating a dual approach to respiratory management in ALS, which has not been previously tested, potentially leading to better care strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. Dorça, A., Alcântara, LA., Diniz, DS., et al.[2022]

Expiratory muscle strength training (EMST) is feasible and safe for individuals who have undergone total laryngectomy, with high compliance observed among participants in the study.

While EMST led to improvements in maximum expiratory pressure and vocal loudness, it did not result in significant changes in other pulmonary function or patient-reported outcomes, suggesting further research is needed in a larger group with more pronounced pulmonary issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study. van Sluis, KE., Kornman, AF., Groen, WG., et al.[2022]

Expiratory muscle training (EMT) significantly increased expiratory muscle strength in healthy adult males, as evidenced by higher maximum expiratory mouth pressure (PEmax) after 4 weeks of training.

EMT also reduced respiratory distress during inspiratory load, with lower Borg scale scores indicating less perceived effort and discomfort during breathing after the training period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Expiratory Muscle Training during Inspiratory Load in Healthy Adult Males: A Randomized Controlled Trial. Tsukamoto, T., Kato, M., Kurita, Y., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Respiratory Strength Training in Amyotrophic Lateral Sclerosis: A Double-Blind, Randomized, Multicenter, Sham-Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A preliminary randomized trial of the mechanical insufflator-exsufflator versus breath-stacking technique in patients with amyotrophic lateral sclerosis. [2017]

3. England pubmed.ncbi.nlm.nih.gov

The effects of lung volume recruitment on coughing and pulmonary function in patients with ALS. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Combined respiratory training in an individual with C9orf72 amyotrophic lateral sclerosis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of expiratory strength training in amyotrophic lateral sclerosis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of expiratory strength training in amyotrophic lateral sclerosis: Results of a randomized, sham-controlled trial. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

POWERbreathe® Inspiratory Muscle Training in Amyotrophic Lateral Sclerosis. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Expiratory Muscle Training during Inspiratory Load in Healthy Adult Males: A Randomized Controlled Trial. [2023]