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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: IMT and Exercise; Behavioral: Inspiratory muscle training (IMT); Behavioral: Exercise alone

• Registration Number: NCT03911206
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-05
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 3: IMT and Exercise	IMT and Exercise	a combination of arm 1 and arm 3
Arm 1 : Inspirtory muscle training (IMT)	Inspiratory muscle training (IMT)	IMT exercises at home will gradually ramp up.
Arm 2: Exercise alone	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States