Skip to main content
OpenTrials
Completed

NCT Number: NCT03752164

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Richmond

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga and Mindfulness Skills

Behavioral

Single brief session in which children are taught yoga and skills in mindfulness

Primary outcomes

  1. Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events

    Time frame: 2 hours

    whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events

Secondary outcomes

  1. Preliminary Effects: Change in FEV1

    Time frame: Baseline to 2 hours

    measuring the change in FEV1 pre and post intervention

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Acronym: K2B2

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2018
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.