Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

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).

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis; Myasthenia Gravis
• Intervention / Treatment: Behavioral: yogic breathing exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yogic breathing exercise; Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.	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.
No Intervention: Waitlist control; Participation in usual daily activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline
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.	at 6 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Hon Yuen, PhD, University of Alabama at Birmingham

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: July 29, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Myasthenia Gravis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: IRB-300011535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No