Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

University of Alabama at Birmingham13 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis Myasthenia Gravis

Interventions

yogic breathing exerciseBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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

ALS Specific Quality of Life-Revised

Time frame: at 6 weeks

Data from ClinicalTrials.gov

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