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Effects of an Exercise Program for Children With Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Exercise program

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Respiratory symptoms, Exercise program, Functional capacity, Body composition

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Infantil Universitario Niño Jesus

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

Children who follow the recommendations of their pneumologist

A two month intervention program 3 days/week will be carried out. The session will last ~60 minutes, and will consist of a combined training (aerobic training ~30 min, and strength ~30 min of 7 whole body exercises (3 sets x 10 repetitions).The load was gradually increased as the strength of each child improved, i.e., from 40% of five-repetition maximum (5RM) lifting ability at the start of the program to 60% of 5RM at the end of the program. All sessions were individually supervised by trained professionals.

Outcomes

Primary Outcome Measures

Change in Pulmonary Function (Lung Function)

Change from baseline to 2 months, and 3 months

Change in Cardiorespiratory Fitness

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

Change in Muscle Strength

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

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)

Change in anxiety

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

Change in Body Mass Index (BMI)

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

Change in Waist-to-Height index

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

Change in anthropometric outcomes

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

Change in Body Composition

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

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)

Change in Agility walking

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

Change in Agility stairs.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02693301

First Posted

February 2, 2016

Last Updated

February 25, 2020

Sponsor

Universidad Europea de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT02693301

Brief Title

Effects of an Exercise Program for Children With Asthma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Respiratory symptoms, Exercise program, Functional capacity, Body composition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Children who follow the recommendations of their pneumologist

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Exercise program

Primary Outcome Measure Information:

Title

Change in Pulmonary Function (Lung Function)

Description

Change from baseline to 2 months, and 3 months

Time Frame