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

Asthma Clinical Trial

— DHBS2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911206
• Other study ID #: Pro00100666
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Inspiratory muscle training (IMT)
IMT exercises at home will gradually ramp up
• 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.
• IMT and Exercise
Combining IMT training and exercise

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participant's with asthma and not participating in any physical activity		6 weeks
Primary	Number of Adverse events reported by participants.		6 weeks
Primary	Number of participants that complete respiratory muscle training (IMT) and exercise.		6 weeks