Amyotrophic Lateral Sclerosis, Myasthenia Gravis
Conditions
Keywords
Amyotrophic Lateral Sclerosis
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).
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.
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors are masked to participant group assignment.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALS Specific Quality of Life-Revised | 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. |
Countries
United States
Outcome results
None listed