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

Duke University

Status: Completed

Conditions: Asthma

Treatments: Behavioral: IMT and Exercise; Behavioral: Inspiratory muscle training (IMT); Behavioral: Exercise alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03911206

Pro00100666

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 4 patient groups

Arm 1 : Inspirtory muscle training (IMT)

Experimental group

Description:

IMT exercises at home will gradually ramp up.

Treatment:

Behavioral: Inspiratory muscle training (IMT)

Arm 2: Exercise alone

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise alone

Arm 3: IMT and Exercise

Experimental group

Description:

a combination of arm 1 and arm 3

Treatment:

Behavioral: IMT and Exercise

Arm 4: Routine care

No Intervention group

Description:

no interventions will occur in this group besides testing procedures and offering access to the study team in case asthma-related questions come up.