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Stacking Exercises Aid the Decline in FVC and Sick Time

NCT01999075 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-01-09

Study results available
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Summary

Duchenne Muscular Dystrophy is complicated by weak breathing muscles and lung infections. "Lung volume recruitment" is a technique performed using a face mask or mouthpiece and a hand-held resuscitation bag to stack breaths, inflate the lungs and help clear the airways of secretions by increasing the forcefulness of a cough. We believe this will slow down the steady loss of lung function, prevent lung infection, and improve quality of life. Our aim is to compare the outcome of a group of individuals with DMD treated with standard care to another group that also receives lung volume recruitment. If effective, this study will change clinical practice by including twice-daily treatment as part of the standard of care for individuals with DMD, in order to improve their lung health and quality of life.

Conditions

Interventions

DEVICE

Lung Volume Recruitment (LVR)

LVR will be used twice per day

OTHER

Conventional Treatment

This may include: a. Physiotherapy, consisting of percussion, active cycle of breathing and/or postural drainage; b. Nutritional support, consisting of oral or tube-fed dietary supplements; c. Antibiotics (oral or intravenous), if there is evidence of respiratory infection; d. Non-invasive positive pressure ventilation, if there is evidence of nocturnal hypoventilation or sleep-disordered breathing; e. Systemic steroids

Sponsors & Collaborators

  • Jesse's Journey

    collaborator OTHER

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Sherri Katz, MD · Children's Hospital of Eastern Ontario

  • Ian MacLusky, MD · Children's Hospital of Eastern Ontario

  • Nicholas Barrowman, PhD · Children's Hospital of Eastern Ontario

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-11-22
Completion
2018-11-22

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01999075 on ClinicalTrials.gov