Effects of an Exercise Program for Children With Asthma

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Exercise program

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

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Children who follow the recommendations of their pneumologist
Experimental: Experimental; 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.	Other: Exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Function (Lung Function)	Change from baseline to 2 months, and 3 months	Baseline, 2 months, and 3 months
Change in Cardiorespiratory Fitness	Change from baseline to 2 months, and 3 months using Cardiorespiratory Test	Baseline, 2 months, and 3 months
Change in Muscle Strength	Change from baseline to 2 months, and 3 months using one repetition maximum test	Baseline, 2 months, and 3 months
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
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
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
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
Change in anthropometric outcomes	Change from baseline to 2 months, and 3 months using skinfolds, and circumferences.	Baseline, 2 months, and 3 months
Change in Body Composition	Change from baseline to 2 months, and 3 months using Bioimpedance.	Baseline, 2 months, and 3 months
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
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
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

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Margarita Perez Ruiz, MD, PhD, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; Body composition; Exercise program; Functional capacity; Respiratory symptoms
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: R-0031/14A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No