Effects of an Exercise Program for Children With Asthma

NCT02693301 | Completed

• 1 other identifier: R-0031/14A
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Interventions

Exercise program OTHER

Experimental

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with other chronic respiratory disease or condition
• Diagnosed with any chronic disease including cardiovascular diseases.
• Reduced mobility
• Uncooperative
• Poor adherence to medication

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Hospital Infantil Universitario Niño Jesus

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Asthma; Signs and Symptoms, Respiratory

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margarita Perez Ruiz, MD, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Exercise Physiology

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 26, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)