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Impact of Exercise on Ashtma in Adults

Primary Purpose

Asthma, Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
workshop
no workshop
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma, sedentarism, spirometry, physical excercise

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Rey Juan CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

no intervention

Arm Description

asthmatic patients who receive the educative intervention

asthmatic patients who don't receive the educative intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 2, 2023
Last Updated
October 2, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT05900128
Brief Title
Impact of Exercise on Ashtma in Adults
Official Title
Impact of Exercise on Asthma Control and Management in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Physical Inactivity
Keywords
asthma, sedentarism, spirometry, physical excercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
asthmatic patients who receive the educative intervention
Arm Title
no intervention
Arm Type
Placebo Comparator
Arm Description
asthmatic patients who don't receive the educative intervention
Intervention Type
Behavioral
Intervention Name(s)
workshop
Intervention Description
Patients will receive workshops and they will encourage to practice physical activity
Intervention Type
Other
Intervention Name(s)
no workshop
Intervention Description
patients won't receive educative workshops
Primary Outcome Measure Information:
Title
Improvement of asthma control
Description
change of 0.5 points in Asthma Control Questionnaire (0-6; higher score means worse result)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Micozzi, MD
Phone
914 81 62 25
Ext
50223
Email
sara.micozzi@hospitalreyjuancarlos.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sarah micozzi, MD
Organizational Affiliation
Hospital Rey Juan Carlos-Instituto de Investigación FJD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Rey Juan Carlos
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sarah micozzi, MD
Phone
914 81 62 25
Ext
50223
Email
sara.micozzi@hospitalreyjuancarlos.es

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pending to decide if share the final report with other researchers

Learn more about this trial

Impact of Exercise on Ashtma in Adults

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