Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Study acronym: iPro
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 22 participants (planned 60)
    • Primary and study completion dates changed from estimate of Jun 2026 to May 20, 2026
    • Interventions: Pro2 - 15% of participant's MIP (Device), Pro2 - 60% of participant's MIP (Device) to Pro2 - 15% of participant's MIP (Device), Pro2 - 60% of participant's MIP (Device)
    • Eligibility criteria expanded, about 18 words
    • Site details revised
  2. Primary and study completion dates: Jun 2025 to Jun 2026
    • Site contact updated
    v8
  3. Primary and study completion dates: Jun 2024 to Jun 2025v7
  4. Start date changed from estimate of Jun 30, 2023 to Jul 27, 2023v6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 5 more changesShow less
    • Start date: Apr 20, 2023 to Jun 30, 2023
    • Primary completion date: Dec 2023 to Jun 2024
    • Study completion date: Jan 2024 to Jun 2024
    • Eligibility criteria expanded, about 23 words
    • Site details revised
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  1. Start date: Mar 2023 to Apr 20, 2023v4
  2. Interventions: Pro2 - 15% of participant's MIP (Device), Pro2 - 75% of participant's MIP (Device) to Pro2 - 15% of participant's MIP (Device), Pro2 - 60% of participant's MIP (Device)
    • Study site revised
    • Eligibility criteria shortened, about 1 word
    v3
  3. Start date: Dec 2022 to Mar 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Duke University
457 trials monitored
See 58 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
Asthma
958 trials monitored
See 36 trials at risk
This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma. Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity
Trial Details
NCT Number NCT05608668
Lead Sponsor Duke University
Collaborators: American Lung Association
Conditions
(from sponsor)		 Pediatric Obesity, Pediatric Asthma
Related terms Asthma, Obesity, Pediatric Obesity
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov