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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03911206
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: Inspiratory muscle training (IMT) Behavioral: Exercise alone Behavioral: IMT and Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : March 5, 2019
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 25, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911206


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03911206    
Other Study ID Numbers: Pro00100666
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases