Clinical trial NCT03752164: Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)
Official title: Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 15
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This proposed pilot study will examine the tolerability, feasibility, acceptability, and preliminary effects of a gentle yoga intervention "Kids 2 Be \& Breathe" (K2B2; a manualized 30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11 with severe asthma.

Detailed description: Pre-Intervention Assessment: permission/assent from the child and consent of the parent/guardian will be obtained and initial data and measurements will be collected to ensure continued eligibility; baseline measures will be assessed.

Intervention: participants will engage in a one-time manualized, age appropriate, 1:1, 30-minute intervention involving gentle yoga and mindfulness techniques in a private room in the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be taught by certified and experienced child yoga instructors who have been trained in the study protocol by the applicant. These yoga instructors collaborated with the interdisciplinary research team in the development of manualized age-appropriate yoga sequences. Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be maintained through the use of a manualized intervention and the PI observing all sessions for manual consistency. The intervention will cease if the participant suffers from any asthma symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle use, chest tightness or shortness of breath, or experiences any other adverse events which precludes the his or her ability to actively participate in the intervention.

Post-Intervention Assessment: upon completion of the intervention, brief semi-structured interviews will be conducted with the child and parent/guardian separately in order to explore the acceptability of the intervention and the PI will again assess the child for any asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign measurements will then be collected.

Eligibility criteria: Inclusion Criteria:

* on medium to high doses of steroids and/or leukotriene inhibitors
* a Child-Asthma Control Test Score \<21

Exclusion Criteria:

* inability to speak English (child); inability to read/write English (parent/guardian)
* child hospitalized in past two weeks for their asthma
* current illness associated with oral temperature \>100.4
* pulse ox \<95% and/or any wheezing, retractions or accessory muscle use

Primary outcomes:
measure: Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events
timeFrame: 2 hours
Secondary outcomes:
measure: Preliminary Effects: Change in FEV1
timeFrame: Baseline to 2 hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Children's Hospital of Richmond
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sharon Lack
role: PRINCIPAL_INVESTIGATOR
References: