NCT03392129

Brief Summary

This study has the aim to assess the effectiveness of the Ai Chi method as an adjunct therapy in the treatment of children with asthma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

December 28, 2017

Last Update Submit

August 8, 2019

Conditions

AsthmaChildRespiratory DiseaseHydrotherapyRespiratory Tract DiseasesRespiratory HypersensitivityRespiration Disorders

Keywords

AsthmaChildrespiratory exercisesHydrotherapyPhysical Therapy SpecialtySleepQuality of lifeAnxietySpirometryClinical trial

Outcome Measures

Primary Outcomes (1)

  • Change in Lung function (spirometry).

    Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow between 25-75% of the pulmonary volume (FEF25-75).

    Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)

Secondary Outcomes (4)

  • Change in asthma control.

    Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)

  • Change in Quality of life

    Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)

  • Change in Anxiety symptoms.

    Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)

  • Change in Disturbed Sleep.

    Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)

Study Arms (2)

Ai Chi

EXPERIMENTAL

Children in the intervention group will perform 12 sessions (twice a week, 40 minutes each session) of treatment with the Ai Chi Method and educational interventions in relation to asthma.

Other: Ai Chi

Asthma education

ACTIVE COMPARATOR

Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.

Other: Asthma education

Interventions

Ai ChiOTHER

Children in the intervention group will perform 12 sessions (twice a week 40 minutes each session) of treatment with the Ai Chi Method, and educational intervention in relation to asthma.

Ai Chi
Asthma educationOTHER

Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.

Asthma education

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from 7 up to 12 years old with asthma diagnose;
  • Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
  • Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), obesity, retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.

You may not qualify if:

  • Children that are not able to perform some of the necessary procedures;
  • Give up participating in the research and present acute symptoms of respiratory tract during the assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Norte (UFRN)

Natal, Rio Grande do Norte, 59078-970, Brazil

RECRUITING

MeSH Terms

Conditions

AsthmaRespiration DisordersRespiratory Tract DiseasesRespiratory HypersensitivityAnxiety Disorders

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesLung Diseases, ObstructiveLung DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Karla Mendonça, PT, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

  • Renata Tomaz, PT, PhD's Student

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

  • Ada Jácome, PT, PhD's student

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

  • Thayla Amorim, PT, Ms

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla Morganna P.P Mendonça, PT, PHD

CONTACT

+55 84 3342-2020karla-morganna@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 5, 2018

Study Start

December 20, 2017

Primary Completion

July 20, 2020

Study Completion

July 20, 2020

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)