RECRUITING

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Conditions

Pediatric Obesity Pediatric Asthma Asthma Obesity Pediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma

Quick Facts

Study Start:2023-07-27

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05608668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Documented informed consent from legal guardian and assent from participant as appropriate. * Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma. * Participants (or parent/guardian) 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. * Participant and legal guardian must speak and read English. * Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)	* Prior intubation for asthma * Current self-reported pregnancy or planning to become pregnant. * Have an FEV1 \< 50% of predicted at screening * History of lung surgery in the past two years, * History of pulmonary embolism in the past two years, * Any history of recurrent spontaneous pneumothorax, or pneumothorax in the past 12 months * Current undiagnosed chest pain, * History of inner ear surgery in the past 12 months, * Undiagnosed syncopal episodes in the past two years, * Progressive neurological or neuromuscular disorders or need for chronic O2 therapy. * Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment. * Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms

Inclusion Criteria

Exclusion Criteria

* Documented informed consent from legal guardian and assent from participant as appropriate.
* Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma.
* Participants (or parent/guardian) 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.
* Participant and legal guardian must speak and read English.
* Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)

* Prior intubation for asthma
* Current self-reported pregnancy or planning to become pregnant.
* Have an FEV1 \< 50% of predicted at screening
* History of lung surgery in the past two years,
* History of pulmonary embolism in the past two years,
* Any history of recurrent spontaneous pneumothorax, or pneumothorax in the past 12 months
* Current undiagnosed chest pain,
* History of inner ear surgery in the past 12 months,
* Undiagnosed syncopal episodes in the past two years,
* Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
* Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment.
* Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms

Contacts and Locations

Study Contact

Veronica Carrion, BS

CONTACT

9197041523

vmp19@duke.edu

Jasong Lang, MD

CONTACT

9196843364

jason.lang@duke.edu

Principal Investigator

Jason Lang, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke Healthy Lifestyles Clinic

Durham, North Carolina, 27704

United States

Collaborators and Investigators

Sponsor: Duke University

Jason Lang, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-27

Study Completion Date2025-06

Study Record Updates

Study Start Date2023-07-27

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

Asthma
Obesity
Pediatric

Additional Relevant MeSH Terms

Pediatric Obesity
Pediatric Asthma