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OpenTrials
Completed

NCT Number: NCT05979688

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. ALS Specific Quality of Life-Revised

    Time frame: baseline

    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.

  2. ALS Specific Quality of Life-Revised

    Time frame: at 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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