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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga and Mindfulness Skills
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Richmond

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga and Mindfulness

Arm Description

An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Preliminary Effects: Change in FEV1
measuring the change in FEV1 pre and post intervention

Full Information

First Posted
November 19, 2018
Last Updated
September 30, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03752164
Brief Title
Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)
Acronym
K2B2
Official Title
Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
September 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga and Mindfulness
Arm Type
Experimental
Arm Description
An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.
Intervention Type
Behavioral
Intervention Name(s)
Yoga and Mindfulness Skills
Intervention Description
Single brief session in which children are taught yoga and skills in mindfulness
Primary Outcome Measure Information:
Title
Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events
Description
whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Preliminary Effects: Change in FEV1
Description
measuring the change in FEV1 pre and post intervention
Time Frame
Baseline to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Lack
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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