Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)

Asthma Clinical Trial

— K2B2  

Official title:

Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752164
• Other study ID #: HM20014054
• Status: Completed
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: September 12, 2019

Study information

• Verified date: September 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Yoga and Mindfulness Skills
Single brief session in which children are taught yoga and skills in mindfulness

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events	whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events	2 hours
Secondary	Preliminary Effects: Change in FEV1	measuring the change in FEV1 pre and post intervention	Baseline to 2 hours