Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

NCT05979688 | Completed

• 1 other identifier: IRB-300011535
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Amyotrophic Lateral Sclerosis; Myasthenia Gravis

Keywords

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Yogic breathing exercise

EXPERIMENTAL

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

Behavioral: yogic breathing exercise

Waitlist control

NO INTERVENTION

Participation in usual daily activities

Interventions

yogic breathing exercise BEHAVIORAL

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

Yogic breathing exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed ALS or myasthenia gravis diagnosis
• age \>18 yrs old;
• ability to follow multistep commands,
• on a stable dose of medications for \>60 days,
• FVC ≥30% predicted,
• access to internet and a computer or smartphone that can perform videoconferencing.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 28229508 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Myasthenia Gravis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hon Yuen, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are masked to participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 7, 2023
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 1, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)