A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma (DHBS2)

November 2, 2020 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

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.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 : Inspirtory muscle training (IMT)
IMT exercises at home will gradually ramp up.
Behavioral: Inspiratory muscle training (IMT)
IMT exercises at home will gradually ramp up
Experimental: Arm 2: Exercise 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.
Behavioral: Exercise 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.
Experimental: Arm 3: IMT and Exercise
a combination of arm 1 and arm 3
Behavioral: IMT and Exercise
Combining IMT training and exercise
No Intervention: Arm 4: Routine care
no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Actual)

February 25, 2020

Study Completion (Actual)

February 25, 2020

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00100666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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