Effects of an Exercise Program for Children With Asthma

Asthma Clinical Trial

Official title:

Effects of an Intra-hospital Exercise Program for Children With Asthma and Respiratory Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693301
• Other study ID #: R-0031/14A
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2018

Study information

• Verified date: February 2020
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

exercise program in the pulmonary function and cardiorespiratory fitness in children with asthma and respiratory symptoms

Description:

This study aims to analyze the effects of an exercise program in the pulmonary function, cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle function, agility, and psychological health in a group of children with asthma and respiratory symptoms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosed with Asthma following the GEMA 2009 criteria (Spanish Guide for Asthma Management) at least 6 months prior to the study.

• Complete successfully both Cardiorespiratory and Functional Tests.

Exclusion Criteria:

• Diagnosed with other chronic respiratory disease or condition

• Diagnosed with any chronic disease including cardiovascular diseases.

• Reduced mobility

• Uncooperative

• Poor adherence to medication

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Exercise program

Locations

Country	Name	City	State
Spain	Hospital Infantil Universitario Niño Jesus	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pulmonary Function (Lung Function)	Change from baseline to 2 months, and 3 months	Baseline, 2 months, and 3 months
Primary	Change in Cardiorespiratory Fitness	Change from baseline to 2 months, and 3 months using Cardiorespiratory Test	Baseline, 2 months, and 3 months
Primary	Change in Muscle Strength	Change from baseline to 2 months, and 3 months using one repetition maximum test	Baseline, 2 months, and 3 months
Primary	Change in Quality of life and anxiety status	Change from baseline to 2 months, and 3 months using the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (Guyatt GH, 1997)	Baseline, 2 months, and 3 months
Primary	Change in anxiety	Change from baseline to 2 months, and 3 months using STAIC (State-Trait Anxiety Inventory for Children)	Baseline, 2 months, and 3 months
Primary	Change in Body Mass Index (BMI)	Change from baseline to 2 months, and 3 months using height and weight.	Baseline, 2 months, and 3 months
Primary	Change in Waist-to-Height index	Change from baseline to 2 months, and 3 months using height and waist.	Baseline, 2 months, and 3 months
Primary	Change in anthropometric outcomes	Change from baseline to 2 months, and 3 months using skinfolds, and circumferences.	Baseline, 2 months, and 3 months
Primary	Change in Body Composition	Change from baseline to 2 months, and 3 months using Bioimpedance.	Baseline, 2 months, and 3 months
Primary	Changes in Physical Activity using questionnaires	Change from baseline to 2 months, and 3 months using Physical Activity Questionnaire for Children (PAQ-C) and Adolescents (PAQ-A)	Baseline, 2 months, and 3 months
Primary	Change in Agility walking	Change from baseline to 2 months, and 3 months using Test of Up and Go	Baseline, 2 months, and 3 months
Primary	Change in Agility stairs.	Change from baseline to 2 months, and 3 months using Test of Up and Down Stairs (TUDS)	Baseline, 2 months, and 3 months