Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Behavioral: yogic breathing exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed ALS diagnosis, age >18 yrs old; ability to follow multistep commands, on a stable dose of any ALS medications for >60 days, FVC ≥70% predicted, Score of either 2 or 3 on the ALSFRS-R Speech subscale, and 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yogic breathing exercise<br>Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week. | Behavioral: yogic breathing exercise<br>* A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique.<br>|
| No Intervention: Waitlist control<br>Participation in usual daily activities | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity (FVC) | Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath. | baseline | 
| Forced vital capacity (FVC) | Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath. | at 6 weeks | 
| Forced vital capacity (FVC) | Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath. | at 3 months | 
| Maximal inspiratory pressure (MIP) | Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm). | baseline | 
| Maximal inspiratory pressure (MIP) | Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm). | at 6 weeks | 
| Maximal inspiratory pressure (MIP) | Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm). | at 3 months | 
| Maximum expiratory pressure (MEP) | Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles) | baseline | 
| Maximum expiratory pressure (MEP) | Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles) | at 6 weeks | 
| Maximum expiratory pressure (MEP) | Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles) | at 3 months | 
| Peak cough flow | Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination. | baseline | 
| Peak cough flow | Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination. | at 6 weeks | 
| Peak cough flow | Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination. | at 3 months | 
| Sentence Intelligibility Test | Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria. | baseline | 
| Sentence Intelligibility Test | Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria. | at 6 weeks | 
| Sentence Intelligibility Test | Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria. | at 3 months | 
| The Consensus Auditory-Perceptual Evaluation of Voice | The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines. | baseline | 
| The Consensus Auditory-Perceptual Evaluation of Voice | The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines. | at 6 weeks | 
| The Consensus Auditory-Perceptual Evaluation of Voice | The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines. | at 3 months | 
| Voice Handicap Index | Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life. | baseline | 
| Voice Handicap Index | Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life. | at 6 weeks | 
| Voice Handicap Index | Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life. | at 3 months | 
| 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 | 
| 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 3 months | 
| ALS Depression Inventory | ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring. | baseline | 
| ALS Depression Inventory | ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring. | at 6 weeks | 
| ALS Depression Inventory | ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring. | at 3 months | 
| Hospital anxiety and depression scale | Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring. | baseline | 
| Hospital anxiety and depression scale | Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring. | at 6 weeks | 
| Hospital anxiety and depression scale | Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring. | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic Lateral Sclerosis