Impact of Exercise on Ashtma in Adults

NCT ID: NCT05900128

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-28

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.

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.

Conditions

Asthma; Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

asthmatic patients who receive the educative intervention

Group Type: ACTIVE_COMPARATOR

workshop

Intervention Type: BEHAVIORAL

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

no intervention

asthmatic patients who don't receive the educative intervention

Group Type: PLACEBO_COMPARATOR

no workshop

Intervention Type: OTHER

patients won't receive educative workshops

Interventions

workshop

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

Intervention Type: BEHAVIORAL

no workshop

patients won't receive educative workshops

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

sarah micozzi, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Rey Juan Carlos-Instituto de Investigación FJD

Locations

Hospital Rey Juan Carlos

Móstoles, Madrid, Spain

Countries

Spain

Other Identifiers

EC075-23_HRJC

Identifier Type: -

Identifier Source: org_study_id