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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yogic breathing exercise | Experimental | Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week. |
|
| Waitlist control | No Intervention | Participation in usual daily activities |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| yogic breathing exercise | Behavioral | A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| 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. | at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hon Yuen, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28229508 | Result | Pagnini F, Marconi A, Tagliaferri A, Manzoni GM, Gatto R, Fabiani V, Gragnano G, Rossi G, Volpato E, Banfi P, Palmieri A, Graziano F, Castelnuovo G, Corbo M, Molinari E, Riva N, Sansone V, Lunetta C. Meditation training for people with amyotrophic lateral sclerosis: a randomized clinical trial. Eur J Neurol. 2017 Apr;24(4):578-586. doi: 10.1111/ene.13246. Epub 2017 Feb 23. |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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Randomized controlled trial
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Assessors are masked to participant group assignment.
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D020511 | Neuromuscular Junction Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |