Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-01

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).

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assessors are masked to participant group assignment.

Study Groups

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Yogic breathing exercise

Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.

Group Type EXPERIMENTAL

yogic breathing exercise

Intervention Type BEHAVIORAL

A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique.

Waitlist control

Participation in usual daily activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No