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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752164
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Yoga and Mindfulness Skills Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma
Actual Study Start Date : May 9, 2019
Actual Primary Completion Date : September 12, 2019
Actual Study Completion Date : September 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Yoga and Mindfulness
An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.
Behavioral: Yoga and Mindfulness Skills
Single brief session in which children are taught yoga and skills in mindfulness




Primary Outcome Measures :
  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 Outcome Measures :
  1. Preliminary Effects: Change in FEV1 [ Time Frame: Baseline to 2 hours ]
    measuring the change in FEV1 pre and post intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752164


Locations
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United States, Virginia
Children's Hospital of Richmond
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Sharon Lack Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03752164     History of Changes
Other Study ID Numbers: HM20014054
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases