AsthmaNCT02693301
Effects of an Exercise Program for Children With Asthma
A study testing Exercise program in people with Asthma, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
exercise program in the pulmonary function and cardiorespiratory fitness in children with asthma and respiratory symptoms Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Diagnosed with other chronic respiratory disease or condition
- Diagnosed with any chronic disease including cardiovascular diseases.
- Reduced mobility
- Uncooperative
- Poor adherence to medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Asthma
- Being tested
- Exercise program
- Keywords
- Asthma, Respiratory symptoms, Exercise program, Functional capacity, Body composition
- Medical subject headings
- Asthma, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary Function (Lung Function)
Change from baseline to 2 months, and 3 months
Measured: Baseline, 2 months, and 3 months
Change in Cardiorespiratory Fitness
Change from baseline to 2 months, and 3 months using Cardiorespiratory Test
Measured: Baseline, 2 months, and 3 months
Change in Muscle Strength
Change from baseline to 2 months, and 3 months using one repetition maximum test
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline, 2 months, and 3 months
Change in anthropometric outcomes
Change from baseline to 2 months, and 3 months using skinfolds, and circumferences.
Measured: Baseline, 2 months, and 3 months
Change in Body Composition
Change from baseline to 2 months, and 3 months using Bioimpedance.
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Perez, Universidad Europea de Madrid
- Investigators
- Margarita Perez Ruiz, MD, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693301
- Sponsor's protocol ID
- R-0031/14A
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2016
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intra-hospital Exercise Program for Children With Asthma and Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT02693301
- Acronym / sponsor ID
- R-0031/14A
- Conditions
- Asthma
- Keywords
- Asthma, Respiratory symptoms, Exercise program, Functional capacity, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Children who follow the recommendations of their pneumologist |
| Experimental | Experimental | Other: Exercise programA 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Diagnosed with other chronic respiratory disease or condition
- Diagnosed with any chronic disease including cardiovascular diseases.
- Reduced mobility
- Uncooperative
- Poor adherence to medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program | Other | Experimental |
Primary outcome
Change in Pulmonary Function (Lung Function)
Time frame: Baseline, 2 months, and 3 months
Change from baseline to 2 months, and 3 months
Change in Cardiorespiratory Fitness
Time frame: Baseline, 2 months, and 3 months
Change from baseline to 2 months, and 3 months using Cardiorespiratory Test
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
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)
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)
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.
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.
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.
Change in Body Composition
Time frame: Baseline, 2 months, and 3 months
Change from baseline to 2 months, and 3 months using Bioimpedance.
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Perez Ruiz, MD, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Asthma, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Function (Lung Function) (time frame: Baseline, 2 months, and 3 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020; AzTrials last refreshed its copy on 3 Nov 2026.