Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979688
• Other study ID #: IRB-300011535
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: August 28, 2025

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: Hon Yuen, PhD
• Phone: 2059346301
• Email: yuen[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 28, 2025
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. confirmed ALS diagnosis,

2. age >18 yrs old;

3. ability to follow multistep commands,

4. on a stable dose of any ALS medications for >60 days,

5. FVC =70% 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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Sentence Intelligibility Test	Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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