NCT05900128

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

July 12, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

June 2, 2023

Last Update Submit

July 11, 2024

Conditions

Keywords

asthmasedentarismspirometryphysical excercise

Outcome Measures

Primary Outcomes (1)

  • Improvement of asthma control

    change of 0.5 points in Asthma Control Questionnaire (0-6; higher score means worse result)

    3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

asthmatic patients who receive the educative intervention

Behavioral: workshop

no intervention

PLACEBO COMPARATOR

asthmatic patients who don't receive the educative intervention

Other: no workshop

Interventions

workshopBEHAVIORAL

Patients will receive workshops and they will encourage to practice physical activity

Intervention

patients won't receive educative workshops

no intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

MeSH Terms

Conditions

AsthmaSedentary Behavior

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Study Officials

  • sarah micozzi, MD

    Hospital Rey Juan Carlos-Instituto de Investigación FJD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

June 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

July 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Pending to decide if share the final report with other researchers

Locations