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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Yogic Breathing Exercises for ALS?

Research suggests that exercise, including respiratory training, can improve motor function and respiratory strength in ALS patients, especially when started early in the disease. Although not specific to yogic breathing, these findings indicate that breathing exercises may help maintain function in ALS. ^{1 2 3 4 5}

Is yogic breathing safe for humans?

Research shows that yogic breathing exercises, like those used in yoga, are generally safe for humans. A review of yoga studies found no serious safety concerns, and any minor issues were similar to those seen with other types of exercise. ^{6 7 8 9 10}

How is the Yogic Breathing Exercise treatment different from other treatments for ALS?

Yogic Breathing Exercise is unique because it focuses on controlled breathing techniques (pranayama) to potentially improve respiratory function and overall well-being, unlike other treatments that often involve mechanical devices or physical exercises. This approach is non-invasive and can be practiced independently, offering a complementary option to traditional therapies. ^{4 5 11 12 13}

What is the purpose of this trial?

This trial tests if an online yogic breathing program can help people with ALS improve their breathing, speech, and emotional health. The exercises aim to strengthen breathing muscles and boost overall well-being.

Research Team

Hon K Yuen, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. United States 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. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Strictly monitored exercise programs reduce motor deterioration in ALS: preliminary results of a randomized controlled trial. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Respiratory exercise in amyotrophic lateral sclerosis. [2022]

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

High-frequency motor rehabilitation in amyotrophic lateral sclerosis: a randomized clinical trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Long-term effects of breathing exercises and yoga in patients with bronchial asthma]. [2009]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of consistent practice of yogic breathing exercises on the human cardiorespiratory system. [2017]

8. United States 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. [2020]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Immediate effect of Kapalbhathi pranayama on short term heart rate variability (HRV) in healthy volunteers. [2021]

11. England 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. [2009]

12. Switzerland pubmed.ncbi.nlm.nih.gov

POWERbreathe&#174; Inspiratory Muscle Training in Amyotrophic Lateral Sclerosis. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Laryngeal response patterns influence the efficacy of mechanical assisted cough in amyotrophic lateral sclerosis. [2018]