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Completed

NCT Number: NCT02693301

Effects of an Exercise Program for Children With Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Infantil Universitario Niño Jesus

Madrid, 28009, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise program

Other

Primary outcomes

  1. Change in Pulmonary Function (Lung Function)

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months

  2. Change in Cardiorespiratory Fitness

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using Cardiorespiratory Test

  3. Change in Muscle Strength

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using one repetition maximum test

  4. Change in Quality of life and anxiety status

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (Guyatt GH, 1997)

  5. Change in anxiety

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using STAIC (State-Trait Anxiety Inventory for Children)

  6. Change in Body Mass Index (BMI)

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using height and weight.

  7. Change in Waist-to-Height index

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using height and waist.

  8. Change in anthropometric outcomes

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using skinfolds, and circumferences.

  9. Change in Body Composition

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using Bioimpedance.

  10. Changes in Physical Activity using questionnaires

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using Physical Activity Questionnaire for Children (PAQ-C) and Adolescents (PAQ-A)

  11. Change in Agility walking

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using Test of Up and Go

  12. Change in Agility stairs.

    Time frame: Baseline, 2 months, and 3 months

    Change from baseline to 2 months, and 3 months using Test of Up and Down Stairs (TUDS)

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2016
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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