Active inspiratory muscle rehabilitation (IMR) group for Pediatric Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke Healthy Lifestyles Clinic, Durham, NC
Pediatric Obesity+1 More
Pro2 - 75% of participant's MIP - Device
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked, interventional trial among children aged 8-17 years (not yet 18 years old) of age with obesity (n=30), recruited from the Duke Healthy Lifestyles 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

Eligible Conditions

  • Pediatric Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: approximately 2 months

Baseline, approximately 2 months
Change in average daily moderate-vigorous physical activity (MVPA) time
Change in average daily sedentary physical activity (SPA) time
Change in average daily step count
Change in dyspnea scores over intervention period
Change in maximum inspiratory pressure (MIP) over intervention period
Heart rate change during 3-minute step test
approximately 2 months
Adherence to active IMR
Participant satisfaction among active IMR participants
Prevalence of completer status

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

SHAM
1 of 2
Active inspiratory muscle rehabilitation (IMR) group
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Active inspiratory muscle rehabilitation (IMR) group · No Placebo Group · N/A

Active inspiratory muscle rehabilitation (IMR) group
Device
Experimental Group · 1 Intervention: Pro2 - 75% of participant's MIP · Intervention Types: Device
SHAM
Device
ActiveComparator Group · 1 Intervention: Pro2 - 15% of participant's MIP · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 months
Closest Location: Duke Healthy Lifestyles Clinic · Durham, NC
Photo of durham  1Photo of durham  2Photo of durham  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Pediatric Obesity
0 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have access to the internet and an approved smart device/computer.
Child must have a designated caregiver who expresses a commitment to encourage the participant to complete the study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.