Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- ALS Specific Quality of Life-Revised
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessors are masked to participant group assignment.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hon K. Yuen, PhD
Professor
University of Alabama at Birmingham