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Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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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.

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
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Mitsubishi Tanabe Pharma