A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma

The Duke Healthy Breathing Study Stage 2 (DHBS): A Randomized Controlled Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03911206

Acronym

DHBS2

Enrollment

Registered

2019-04-11

Start date

2019-03-05

Completion date

2020-02-25

Last updated

2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma

Brief summary

The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory Muscle Training and cardiovascular exercise training program in children and adolescents with asthma. To also determine the efficacy of inspiratory muscle training and exercise in increasing respiratory muscle strength and endurance, and to explore relationships between fitness interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure and dyspnea scores.

Interventions

BEHAVIORALInspiratory muscle training (IMT)

IMT exercises at home will gradually ramp up

BEHAVIORALExercise alone

Subjects will be asked to exercise 2x/week for 6 weeks in person at the Duke research facility and again 2x/week at home for 30 minutes.

BEHAVIORALIMT and Exercise

Combining IMT training and exercise

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

Inclusion criteria

* 10-17 years of age * Clinician-diagnosed asthma * Sedentary activity defined as having not participated in a sports team or formal activity (dance classes, gym membership, active hobby requiring physical activity) in the past 12 months or have a * Body mass index (BMI) ≥85th percentile (adjusted for sex and age) * Child must have a designated caregiver who expresses a commitment to encourage the participant to attend weekly clinic-based exercise and also complete additional home exercise.

Exclusion criteria

* Previous intubation for asthma, * Forced expiratory volume in 1 second (FEV1) \< 50% of predicted at enrollment; * Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures; * Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI * Currently active in sports, vigorous play or planned exercise more than 1 time per week on average over the past month * Current Pregnancy as determined by urine pregnancy test. * Parent/Caregiver unable to consent in English

Design outcomes

Primary

Measure	Time frame
Percentage of Participant's with asthma and not participating in any physical activity	6 weeks
Number of Adverse events reported by participants.	6 weeks
Number of participants that complete respiratory muscle training (IMT) and exercise.	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026