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NCT03911206 | Completed | Asthma

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

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

Asthma

Intervention/treatment

Inspiratory muscle training (IMT)

Exercise alone

IMT and Exercise

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 11 participants
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
Estimated Primary Completion Date : February 25, 2020
Estimated Study Completion Date : February 25, 2020
Arm Intervention/treatment

Experimental: Arm 1 : 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.

Experimental: Arm 3: IMT and Exercise

a combination of arm 1 and arm 3

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.
Ages Eligible for Study: 10 Years to 17 Years
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
A Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma

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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

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Locations

Not yet recruiting

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710