Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Study Purpose

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-being in people with amyotrophic lateral sclerosis (ALS).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. confirmed ALS or myasthenia gravis diagnosis. 2. age >18 yrs old; 3. ability to follow multistep commands, 4. on a stable dose of medications for >60 days, 5. FVC ≥20% predicted, 6. Score of either 2 or 3 on the ALSFRS-R "Speech" subscale, and. 7. access to internet and a computer or smartphone that can perform videoconferencing.

Exclusion Criteria:

1. life expectancy is less than 6 months, 2. severe hearing or visual impairments that prevent online learning (breathing exercise), or. 3. current participation in another clinical trial during the study period that can affect the outcomes of the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05979688
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hon Yuen, PhD
Principal Investigator Affiliation	University of Alabama at Birmingham
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Amyotrophic Lateral Sclerosis, Myasthenia Gravis

Additional Details

The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 3 two-way factorial design with repeated measures at three time points. The two between-subject factor conditions will be participation in a yogic breathing exercise program (YBEP) versus a waitlist control condition that will be evaluated at baseline, immediately post-program, and at 3-month follow-up. Thirty adults with ALS will be recruited for this study. Hypothesis #1: Adults with ALS who participate in a YBEP will demonstrate improvement in breathing, speech function, and emotional well-being compared to waitlist controls at the conclusion of a 6-week YBEP. Hypothesis #2: The positive impact of the YBEP on the participants' improved breathing, speech function, and emotional well-being will be maintained at 3-month follow-up.

Arms & Interventions

Arms

Experimental: Yogic breathing exercise

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

No Intervention: Waitlist control

Participation in usual daily activities

Interventions

Behavioral: - yogic breathing exercise

A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Hon K Yuen, PhD

[email protected]

2059346301

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