Yogic Breathing Exercises for ALS

Overseen By Hon Yuen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Life expectancy <6 months, severe impairments, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 6-week virtual yogic breathing program can help individuals with ALS (amyotrophic lateral sclerosis) improve breathing, speech, and emotional well-being. Participants will either engage in this breathing program or continue their usual activities. It suits individuals diagnosed with ALS or myasthenia gravis who can follow multi-step instructions and have internet access for virtual sessions. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to enhance the quality of life for those with ALS.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of their medications for more than 60 days, so you will not need to stop taking your current medications.

What prior data suggests that these yogic breathing exercises are safe for people with ALS?

Research has shown that breathing exercises used in yoga are generally safe for people. A review of various yoga studies found no serious safety issues with these exercises. Participants can expect these breathing exercises to be manageable, with little risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of yogic breathing exercises for people with ALS, a condition that typically relies on medications like Riluzole and Edaravone to manage symptoms. Unlike these standard drug treatments, yogic breathing is a non-pharmacological approach that may improve respiratory function and overall well-being without the risk of medication side effects. This technique is also accessible and can be practiced virtually, offering a convenient and potentially more holistic way to support those living with ALS. By investigating this method, researchers hope to discover complementary strategies that enhance quality of life alongside traditional medical treatments.

What evidence suggests that yogic breathing exercises might be an effective treatment for ALS?

This trial will compare the effects of yogic breathing exercises with a waitlist control group. Research has shown that exercise, including breathing exercises, can strengthen muscles in people with ALS. A long-term study found that a patient with a specific type of ALS had much stronger breathing muscles after following a breathing strength training program. Additionally, moderate daily exercise can slow movement loss, reduce fatigue, and lessen pain in people with ALS. Although specific data on yogic breathing exercises is limited, their focus on controlled breathing might enhance these benefits. Overall, exercise programs appear promising for improving some physical abilities in people with ALS. ^{1 2 3 6 7}

Who Is on the Research Team?

Hon K Yuen, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with ALS who can use the internet and follow instructions. They should be able to speak, have a certain level of lung function (FVC ≥70%), and not expect to live less than 6 months. They shouldn't be in another study or have severe hearing or vision problems.

Inclusion Criteria

I can understand and follow complex instructions.

I have been on a consistent dose of my ALS medication for over 60 days.

Access to internet and a computer or smartphone that can perform videoconferencing

Exclusion Criteria

You are expected to live for less than 6 months.

You have difficulty hearing or seeing that makes it hard for you to do breathing exercises online.

Current participation in another clinical trial during the study period that can affect the outcomes of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week virtual yogic breathing exercise program (YBEP) with 1-3 sessions per week

6 weeks

6 weekly virtual sessions

Follow-up

Participants are monitored for the maintenance of improvements in breathing, speech function, and emotional well-being

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Yogic Breathing Exercise

Trial Overview The trial tests a virtual yogic breathing exercise program over six weeks, aiming to improve breathing, speech, and emotional well-being in people with ALS.

How Is the Trial Designed?

Group I: Yogic breathing exercise Experimental Treatment 1 Intervention

Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.

Group II: Waitlist control Active Control 1 Intervention

Participation in usual daily activities

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

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&#174; Inspiratory Muscle Training in Amyotrophic Lateral Sclerosis. Vicente-Campos, D., Sanchez-Jorge, S., Chicharro, JL., et al.[2023]

In a study of 20 ALS patients and 20 healthy volunteers, it was found that patients with bulbar symptoms exhibited abnormal laryngeal movements during mechanical insufflation-exsufflation (MI-E), which compromised their ability to cough effectively.

Customizing MI-E settings for individual patients, especially those with bulbar symptoms, could enhance the effectiveness of this non-invasive treatment by addressing the observed laryngeal adduction that limits airway size during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal response patterns influence the efficacy of mechanical assisted cough in amyotrophic lateral sclerosis. Andersen, T., Sandnes, A., Brekka, AK., et al.[2018]

In a study of 26 early-affected ALS patients, specific inspiratory muscle training did not show significant differences in overall outcomes compared to a placebo exercise program over eight months.

However, within-group analysis indicated that inspiratory exercise may lead to temporary improvements in certain respiratory functions, suggesting that further investigation into exercise regimes for ALS patients is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory exercise in amyotrophic lateral sclerosis. Pinto, S., Swash, M., de Carvalho, M.[2022]

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]

In a randomized clinical trial involving 65 ALS patients, an intensive exercise regimen (five sessions per week) did not show any significant benefits over a usual exercise regimen (two sessions per week) in slowing disease progression as measured by the ALS Functional Rating Scale.

Both exercise regimens resulted in similar outcomes regarding survival, respiratory function, quality of life, and caregiver burden, indicating that increasing exercise frequency may not provide additional advantages for ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency motor rehabilitation in amyotrophic lateral sclerosis: a randomized clinical trial. Zucchi, E., Vinceti, M., Malagoli, C., et al.[2022]

Muscle strengthening exercises can significantly improve knee extension muscle strength and functional ambulation in patients with early-stage ALS, particularly when initiated within the first year of onset.

The study suggests that exercise benefits are greater in the early stages of ALS, with improvements maintained for up to 10 months in some cases, highlighting the importance of starting exercise therapy early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of muscle strengthening exercise and time since onset in patients with amyotrophic lateral sclerosis: A 2-patient case series study. Kato, N., Hashida, G., Konaka, K.[2021]

In a randomized controlled trial involving 60 ALS patients, a strictly monitored exercise program (SMEP) significantly improved motor function as measured by the ALS Functional Rating Scale (ALSFRS-R) compared to usual care over a 6-month period.

While the SMEP did not affect survival rates or respiratory function, it showed promise in reducing motor deterioration, indicating that structured exercise may be beneficial for ALS patients in maintaining their physical abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strictly monitored exercise programs reduce motor deterioration in ALS: preliminary results of a randomized controlled trial. Lunetta, C., Lizio, A., Sansone, VA., et al.[2022]

Breathing exercises (BE) significantly improved lung function in patients with mild bronchial asthma, with a notable increase in FEV1 by 356.3 ml and a decrease in residual volume (RV) by 306.3 ml, compared to baseline values.

While both breathing exercises and yoga improved the mental state of participants, only BE showed a significant enhancement in lung function, suggesting that BE may be a beneficial complementary therapy alongside standard asthma treatments like albuterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term effects of breathing exercises and yoga in patients with bronchial asthma]. Flüge, T., Richter, J., Fabel, H., et al.[2009]

The yogic breathing exercise chaturbhuj creates a hypoxic effect in experienced practitioners, lowering end-tidal oxygen tension compared to controls, which may enhance respiratory efficiency.

Consistent practice of bhastrika leads to significant changes in cardiovascular responses, such as increased mean arterial pressure and middle cerebral artery velocity during breath-holding, while also reducing central chemosensitivity in experienced yogic breathers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of consistent practice of yogic breathing exercises on the human cardiorespiratory system. McKay, JA., McCulloch, CL., Querido, JS., et al.[2017]

A significant portion of young adults (43.9%) reported experiencing adverse childhood events, which were linked to higher stress levels, highlighting a critical public health concern.

Despite the challenges faced, 12.7% of the young adults practiced yoga for at least 30 minutes a week, with those exposed to adverse events practicing yoga at equal or greater rates than their peers, suggesting yoga could be a beneficial coping strategy for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. Neumark-Sztainer, D., Wall, MM., Choi, J., et al.[2020]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

A study involving 50 healthy volunteers showed that practicing Kapalbhathi Pranayam for 5 minutes led to an initial increase in sympathetic activity, indicated by parasympathetic withdrawal, immediately after the exercise.

However, after a 20-minute recovery period, the participants exhibited a shift to parasympathetic dominance, suggesting that Kapalbhathi Pranayam may enhance cardiac autonomic function over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effect of Kapalbhathi pranayama on short term heart rate variability (HRV) in healthy volunteers. Lalitha, S., Maheshkumar, K., Shobana, R., et al.[2021]

In a study of 161 ALS patients, a maximal inspiratory pressure (MIP) of less than -60 cm H(2)O was found to be a more sensitive indicator for initiating non-invasive ventilation (NIV) compared to a forced vital capacity (FVC) of less than 50%, with 65% of patients meeting the MIP criterion versus only 8% for FVC.

Patients reached the MIP criterion 4 to 6.5 months earlier than the FVC criterion, suggesting that using MIP allows for earlier intervention with NIV, which could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of maximal inspiratory pressure and forced vital capacity as potential criteria for initiating non-invasive ventilation in amyotrophic lateral sclerosis. Mendoza, M., Gelinas, DF., Moore, DH., et al.[2009]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05979688?term=AREA%5BBasicSearch%5D(exercise%20als)&rank=5

Yogic Breathing Exercise for People With Amyotrophic ... The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well- ...

2. withpower.com withpower.com/trial/phase-2-motor-neuron-disease-8-2023-39873

Yogic Breathing Exercises for ALS · Info for Participants A 24-month respiratory strength training program significantly improved inspiratory and expiratory muscle strength in a patient with C9orf72 amyotrophic ...

3. als.net als.net/als-trial-navigator/500103/

Trial: Yogic Breathing Exercise for People With Amyotroph... The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7739242/

Effects of Physical Activity on Amyotrophic Lateral Sclerosis [32] showed that a moderate daily exercise program decreased the loss of motor function, fatigue, and pain of ALS patients after 6 months. Improvements in motor ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133518/

The effect of exercise intervention on amyotrophic lateral ... Meta-analysis results show that exercise intervention can significantly improve the overall function, walking test (WT) distance and maximum expiratory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3994974/

Meditation Training for People with Amyotrophic Lateral ... We believe our protocol is open to all ALS patients whose diagnosis occurred no more than 18 months earlier and who have an Amyotrophic Lateral Sclerosis ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/mus.70018

Proceedings of the 24th Annual NEALS Meeting - 2025 ... amyotrophic lateral sclerosis (ALS), with global safety reviews conducted since approval. Objective: Use postmarketing pharmacovigilance data ...