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Respiratory Muscle Training in L-Onset Pompe Disease (LOPD)

NCT02801539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-07-30

No results posted yet for this study

Summary

This study is being done to test the effects of respiratory muscle training (RMT) in patients with late-onset Pompe Disease (LOPD) who have weakness of their breathing muscles. The results of this study will help design future research studies about RMT in LOPD. The goals of this study are to decide if sham-RMT is a useful control condition for RMT and to choose the best ways to measure the health benefits of RMT in LOPD.

Conditions

  • Glycogen Storage Disease Type II

Interventions

DEVICE

RMT therapy using modified RMT device

The exercises provided by the RMT device is intended to strengthen breathing muscles.

DEVICE

Sham-RMT therapy using modified RMT device

The exercises provided by the Sham-RMT modified device is not intended to strengthen breathing muscles.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Harrison Jones, PhD · Division of Head and Neck Surgery & Communication Sciences, Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2018-10-22
Completion
2019-04-17

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801539 on ClinicalTrials.gov