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Behavioural Intervention
Combined Respiratory Training for ALS
N/A
Recruiting
Research Sponsored by Nova Southeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lung volume recruitment and expiratory muscle strength training naïve
Reduced peak cough flow (% predicted for age and gender)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline 1 to final evaluation (10 weeks)
Awards & highlights
Study Summary
This trial aims to understand how a combination of lung volume recruitment and expiratory muscle strength training can improve cough strength, respiratory function, dyspnea, bulbar impairment, caregiver burden, and quality of life in patients with ALS.
Who is the study for?
This trial is for people with ALS who have had symptoms for less than 2 years, can't already use respiratory training devices, and don't have a tracheostomy or need invasive breathing support. They shouldn't be in other studies that affect coughing or breathing and must not have severe lung diseases like COPD.Check my eligibility
What is being tested?
The study tests if combining two types of breathing exercises (LVR+EMST) helps improve cough strength, breath control, swallowing difficulties, and overall quality of life in up to 39 patients with ALS. It also looks at the impact on caregiver burden.See study design
What are the potential side effects?
Potential side effects may include discomfort from the exercises, fatigue due to increased respiratory effort during training sessions, and possible soreness in muscles involved in respiration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never undergone lung volume or expiratory muscle strength training.
Select...
My cough strength is weaker than normal for my age and gender.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline 1 to final evaluation (10 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline 1 to final evaluation (10 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak Cough Flow
Secondary outcome measures
Cough Spirometry
Pulmonary Function Assessment
Other outcome measures
ALS Functional Rating Scale-Revised (ALSFRS-R, Cedarbaum et al., 2011)
Center for Neurological Study-Bulbar Function Scale (CNS-BFS, Smith et al., 2011)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lung Volume Recruitment +Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention
All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen following a 5-week no-intervention lead-in period.
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Who is running the clinical trial?
Nova Southeastern UniversityLead Sponsor
89 Previous Clinical Trials
11,607 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
48 Previous Clinical Trials
6,742 Total Patients Enrolled
Magalie Thomas, MBAStudy ChairNova Southeastern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never undergone lung volume or expiratory muscle strength training.My symptoms started less than 2 years ago.I have a tracheostomy or use a ventilator to help me breathe.I am not part of another study that could affect my cough or breathing.I do not have severe lung problems or a history of collapsed lung.I use a machine to help with my cough or breathing.My cough strength is weaker than normal for my age and gender.I have been diagnosed with frontotemporal dementia or severe memory problems.I have a history of stroke, head and neck cancer, or conditions that could affect swallowing or breathing.You have been diagnosed with probable or definite ALS based on specific criteria.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Lung Volume Recruitment +Expiratory Muscle Strength Training
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a chance I can join the experiment?
"Eligibility for this clinical trial necessitates that patients have respiratory insufficiency and are aged between 18 to 90 years old. A total of 34 participants need to be enrolled in the study."
Answered by AI
Are there still opportunities available for participants in this experiment?
"Currently, this medical study is not taking on any new patients. The trial initially went live on August 1st 2023 and was last updated June 13th 2023; however a plethora of other trials are actively looking for participants."
Answered by AI
Does this study encompass geriatric patients?
"This medical trial requires participants to be between the ages of 18 and 90. Conversely, there are 33 trials for minors under 18 years old and 227 clinical studies that cater specifically to those aged 65 or above."
Answered by AI
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