Impact of Exercise on Ashtma in Adults

July 11, 2024 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Impact of Exercise on Asthma Control and Management in Adults

The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. All patients will use a step counter in order to evaluate their activity during the study. Spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. Finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

52 asthmatic will be enrolled and randomized into 2 groups. All patients will send a weekly summary of their physical activity (mean number of steps and time of physical activity). All patients will be undergone to a medical visit at month 1 and 3 since study start. In each visit a spirometry, a FeNo, ACQ and AQLQ questionnaires will be done.

The patients of the intervention group will receive 3 workshops about asthma and physical exercise in order to provide information, medical support, and to resolve any question or difficulty about it. The workshops will be al week 1, 2 and 4 since study start.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Móstoles, Madrid, Spain, 28933
        • Hospital Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • asthma well controlled
  • sedentarism (<150 min physical activity/day and/or <7000 daily steps)

Exclusion Criteria:

  • pregnancy
  • cardiological, not well controlled deseases
  • other cronic pulmonary deseases
  • bad asthma control
  • not sign IC
  • unable to practice physical activity (for cognitive or physical conditions)
  • no devices able to count steps and physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
asthmatic patients who receive the educative intervention
Behavioral: workshop
Patients will receive workshops and they will encourage to practice physical activity
Placebo Comparator: no intervention
asthmatic patients who don't receive the educative intervention
Other: no workshop
patients won't receive educative workshops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of asthma control
Time Frame: 3 months
change of 0.5 points in Asthma Control Questionnaire (0-6; higher score means worse result)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

  • Principal Investigator: sarah micozzi, MD, Hospital Rey Juan Carlos-Instituto de Investigación FJD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC075-23_HRJC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pending to decide if share the final report with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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