Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
- Conditions
- Myasthenia GravisAmyotrophic Lateral Sclerosis
- Interventions
- Behavioral: yogic breathing exercise
- Registration Number
- NCT05979688
- Lead Sponsor
- University of Alabama at Birmingham
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- confirmed ALS or myasthenia gravis diagnosis
- age >18 yrs old;
- ability to follow multistep commands,
- on a stable dose of medications for >60 days,
- FVC ≥20% 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yogic breathing exercise yogic breathing exercise Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.
- Primary Outcome Measures
Name Time Method Forced vital capacity (FVC) at 3 months Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.
Maximal inspiratory pressure (MIP) at 3 months 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).
Maximum expiratory pressure (MEP) at 3 months 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)
Voice Handicap Index at 3 months 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.
The Consensus Auditory-Perceptual Evaluation of Voice at 3 months 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.
ALS Specific Quality of Life-Revised at 3 months 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.
ALS Depression Inventory at 3 months 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.
Hospital anxiety and depression scale at 3 months 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.
University of California-San Diego Shortness of Breath Questionnaire(UCSD-SOB) at 3 months It measures one's shortness of breath while doing an activity. It consists of 24 items. Each item is scored from 0 to 5, with 0 representing None at all, and 5 representing maximum or unable to do because of shortness of breath. The total scores ranges from 0 to 120, with higher scores indicating more severe shortness of breath.
Peak cough flow at 3 months 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.
Sentence Intelligibility Test at 3 months Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.
Myasthenia Gravis Activity of Daily Living at 3 months The Myasthenia Gravis Activity of Daily Living (MG-ADL) is an 8- item patient-reported measure combining items about daily life activities and MG symptoms. Total scores range from 0 to 24, with a higher score reflecting more disease severity.
Myasthenia Gravis Quality of Life at 3 months The 15- item Myasthenia Gravis Quality of Life (MG-QoL15) is a disease-specific QoL measure. It has 15 items scored on a Likert scale of 0-4. Potential scores range from 0 to 60, with higher scores indicating worse health-related quality of life (HRQoL).
Neuro-QoL-Fatigue short form (Neuro-QoL-Fatigue-SF) at 3 months 3. The Neuro-QoL-Fatigue short form (Neuro-QoL-Fatigue-SF) has 8 patient-reported items. Patients answer each item using a 5-level Likert scale ranging between 1 never to 5 always, with a 7-day recall period. Total raw scores are calculated through summation of all 8 items and can range from 8 to 40, with higher scores indicating more fatigue
Myasthenia Gravis Impact Index (MGII) at 3 months The MGII measures MG severity through 22 patient-reported items. Total raw scores are determined by summation of individual items and range from 0 to 66, where higher scores signify more severe disease.
Myasthenia gravis disability assessment at 3 months 5. Myasthenia gravis disability assessment (MG-DIS) consists of 20 items addresses impairments and activity limitations. Each item is scored from 0 to 3, with 0 representing normal function and 3 representing the loss of ability to perform that function. The total score ranges from 0 to 60 points, with higher scores indicating more severe generalized myasthenia gravis.
Modified Medical Research Council Dyspnoea Scale at 3 months It assess the degree of baseline functional disability due to dyspnoea. The scale with one item ranges from grade 0 to 4, with 0= only get breathless with strenuous exercise, and 4= breathless when dressing/undressing.
Insomnia Severity Index at 3 months 8. The Insomnia Severity Index (ISI) is composed of seven items that evaluate the severity of sleep disturbance during the past 2 weeks. Each item is rated on a five-point Likert scale and the total score indicates the severity of insomnia.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States