Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts 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 ≥20% predicted, 6. Score of either 2 or 3 on the ALSFRS-R "Speech" subscale, and 7. 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Assessors are masked to participant group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Yogic breathing exercise
Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.
  • Behavioral: yogic breathing exercise
    A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique.
No Intervention
Waitlist control
Participation in usual daily activities

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Hon K Yuen, PhD

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Hon Yuen, PhD
2059346301
yuen@uab.edu

Detailed Description

The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 3 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, immediately post-program, and at 3-month follow-up. 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, speech function, and emotional well-being compared to waitlist controls at the conclusion of a 6-week YBEP. Hypothesis #2: The positive impact of the YBEP on the participants' improved breathing, speech function, and emotional well-being will be maintained at 3-month follow-up.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.