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Completed

NCT Number: NCT03911206

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training (IMT)

Behavioral

IMT exercises at home will gradually ramp up

exercise alone

Behavioral

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.

IMT and Exercise

Behavioral

Combining IMT training and exercise

Primary outcomes

  1. Percentage of Participant's with asthma and not participating in any physical activity

    Time frame: 6 weeks

  2. Number of Adverse events reported by participants.

    Time frame: 6 weeks

  3. Number of participants that complete respiratory muscle training (IMT) and exercise.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: DHBS2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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