Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224961
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2020-01-08
Brief Title:
Respiratory Muscle Training RMT in ALS
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Moderate Intensity Respiratory Muscle Training RMT in ALS
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Twelve adults with ALS will participate in a study involving four 3-week cycles of progressive respiratory muscle training RMT The investigators will measure maximum inspiratory pressure MIP and maximum expiratory pressure MEP weekly The investigators will obtain the majority of measurements of MIP and MEP during web-based telehealth visits Participants will be stratified into 2 groups based on baseline inspiratory muscle strength as determined by maximum inspiratory pressure MIP six participants with minimal to no respiratory weakness ie MIP 70 predicted and six participants with mild to moderate inspiratory weakness ie MIP 40-70 predicted
Detailed Description:
Twelve adults will participate in a single- subject A1-B-A2 study involving 4 visits to Duke over 24 weeks The 6 week delayed start period A1 will establish baseline status prior to initiation of RMT B and the follow-up period A2 will determine detraining effects over 6 weeks of RMT withdrawal Participants will complete four 3-week cycles of progressive RMT during the B phase The investigators will measure MIP and MEP weekly To reduce participant burden and enhance our ability to obtain repeated measures the investigators will obtain 21 of 25 measurements of MIP and MEP during web-based telehealth visits
Participants will complete a full assessment during the first study visit M1 and receive traininginstruction for obtaining MIP and MEP measurements at home with a portable battery-powered digital pressure gauge manometer MicroRPM Pressure Meter Micro Direct They will return to Duke for the pretest visit M7 at which time a full assessment will be completed and RMT will commence During the B phase participants will complete 12-weeks of moderate intensity RMT divided into four 3-week cycles and participate in weekly web-based RMT therapy visits M8-M18 Post-test assessment M19 will occur immediately following completion of the 12-week RMT regimen The investigators will measure MIP and MEP during RMT withdrawal via web-based telehealth visits M20-24 Following the fourth and final on-site full assessment visit M25 participants will return all equipment and will be offered the opportunity to initiate a clinical RMT regimen and receive follow-up care by Speech Pathology during future ALS Clinic visits
Participants will be stratified into 2 groups based on baseline inspiratory muscle strength as determined by maximum inspiratory pressure MIP six participants with minimal to no respiratory weakness ie MIP 70 predicted and six participants with mild to moderate inspiratory weakness ie MIP 40-70 predicted
The primary outcomes are MIP and MEP Secondary outcomes include peak cough flow PCF and sniff nasal inspiratory pressure SNIP Exploratory outcomes include the Amyotrophic Lateral Sclerosis Functional Rating Scale ALSFRS Eating Assessment Tool - 10 Item EAT-10 36-Item Short Form Survey SF36 World Health Organization Quality of Life-BREF WHOQOL-BREF and Communicative Effectiveness Survey-Revised CES-R Clinical spirometry data will be extracted from the participants electronic medical record if available from a coinciding ALS Clinic visit that occurs - 5 days from the assessment visit
Participants will complete a full assessment during the first study visit M1 and receive traininginstruction for obtaining MIP and MEP measurements at home with a portable battery-powered digital pressure gauge manometer MicroRPM Pressure Meter Micro Direct They will return to Duke for the pretest visit M7 at which time a full assessment will be completed and RMT will commence During the B phase participants will complete 12-weeks of moderate intensity RMT divided into four 3-week cycles and participate in weekly web-based RMT therapy visits M8-M18 Post-test assessment M19 will occur immediately following completion of the 12-week RMT regimen The investigators will measure MIP and MEP during RMT withdrawal via web-based telehealth visits M20-24 Following the fourth and final on-site full assessment visit M25 participants will return all equipment and will be offered the opportunity to initiate a clinical RMT regimen and receive follow-up care by Speech Pathology during future ALS Clinic visits
Participants will be stratified into 2 groups based on baseline inspiratory muscle strength as determined by maximum inspiratory pressure MIP six participants with minimal to no respiratory weakness ie MIP 70 predicted and six participants with mild to moderate inspiratory weakness ie MIP 40-70 predicted
The primary outcomes are MIP and MEP Secondary outcomes include peak cough flow PCF and sniff nasal inspiratory pressure SNIP Exploratory outcomes include the Amyotrophic Lateral Sclerosis Functional Rating Scale ALSFRS Eating Assessment Tool - 10 Item EAT-10 36-Item Short Form Survey SF36 World Health Organization Quality of Life-BREF WHOQOL-BREF and Communicative Effectiveness Survey-Revised CES-R Clinical spirometry data will be extracted from the participants electronic medical record if available from a coinciding ALS Clinic visit that occurs - 5 days from the assessment visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None