Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)
K2B2
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started May 2019
Shorter than P25 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2019
CompletedOctober 2, 2019
September 1, 2019
4 months
November 19, 2018
September 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Preliminary Effects: Change in FEV1
Baseline to 2 hours
Study Arms (1)
Yoga and Mindfulness
EXPERIMENTALAn intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.
Interventions
Single brief session in which children are taught yoga and skills in mindfulness
Eligibility Criteria
You may qualify if:
- on medium to high doses of steroids and/or leukotriene inhibitors
- a Child-Asthma Control Test Score \<21
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Richmond
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Lack
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 23, 2018
Study Start
May 9, 2019
Primary Completion
September 12, 2019
Study Completion
September 12, 2019
Last Updated
October 2, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share