Asthma Clinical Trial - Kids 2 Be & Breathe: A Study on the Use of Yoga &

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Asthma

Clinical Trial Details

NCT number	NCT03752164
Study type	Interventional
Source	Virginia Commonwealth University
Contact
Status	Completed
Phase	N/A
Start date	May 9, 2019
Completion date	September 12, 2019

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04410523` - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04624425` - Additional Effects of Segmental Breathing In Asthma	N/A
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)	N/A
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT03694158` - Investigating Dupilumab's Effect in Asthma by Genotype	Phase 4
Terminated	`NCT04946318` - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Completed	`NCT03086460` - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)	Phase 2
Completed	`NCT01160224` - Oral GW766944 (Oral CCR3 Antagonist)	Phase 2
Completed	`NCT03186209` - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)	Phase 3
Completed	`NCT02502734` - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma	Phase 3
Completed	`NCT01715844` - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics	Phase 1
Terminated	`NCT04993443` - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036	Phase 1
Completed	`NCT02787863` - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology	Phase 4
Recruiting	`NCT06033833` - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study	Phase 2
Completed	`NCT03257995` - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.	Phase 2
Completed	`NCT02212483` - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn	`NCT01468805` - Childhood Asthma Reduction Study	N/A
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms