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CompletedNCT05979688Updated Aug 8, 2025

Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

An interventional study of yogic breathing exercise in Amyotrophic Lateral Sclerosis and Myasthenia Gravis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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).

Read the detailed description

The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 2 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, and immediately post-program. 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, and emotional well-being compared to waitlist controls at the conclusion of a 6-week YBEP.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • Myasthenia Gravis

Keywords

  • Amyotrophic Lateral Sclerosis
03

In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 282 are open to participants now.

This study's enrollment of 13 is below the median of 36 across 667 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 ≥30% predicted,
  6. access to internet and a computer or smartphone that can perform videoconferencing.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Yogic breathing exercise

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

    Behavioral: yogic breathing exercise

  • No intervention
    Waitlist control

    Participation in usual daily activities

Interventions

  • Behavioralyogic breathing exercise

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

06

What researchers measure

Primary outcomes

  1. ALS Specific Quality of Life-Revised

    ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.

    Time frame: baseline

  2. ALS Specific Quality of Life-Revised

    ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.

    Time frame: at 6 weeks

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
08

References and documents

Publications

  • Pagnini F, Marconi A, Tagliaferri A, Manzoni GM, Gatto R, Fabiani V, Gragnano G, Rossi G, Volpato E, Banfi P, Palmieri A, Graziano F, Castelnuovo G, Corbo M, Molinari E, Riva N, Sansone V, Lunetta C. Meditation training for people with amyotrophic lateral sclerosis: a randomized clinical trial. Eur J Neurol. 2017 Apr;24(4):578-586. doi: 10.1111/ene.13246. Epub 2017 Feb 23. PubMed 28229508 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05979688
Lead sponsor
University of Alabama at Birmingham
Responsible party
Hon K. Yuen, PhD (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 7, 2023
Start date
Nov 1, 2023
Primary completion
Oct 31, 2024
Completion
Nov 1, 2024
Last update
Aug 8, 2025

Study contacts

Hon Yuen, PhD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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