Asthma Control: Increased Physical Activity in Young Adults
August 2, 2022 updated by: Jason Woloski, Geisinger Clinic
Impact of Increased Physical Activity in Young Adult Asthmatic Patients on Patient Perception of Pulmonary Health and Exercise
Investigators want to study to see if patients who participate in a physical activity intervention involving increasing daily step counts will have better mini asthma quality of life questionnaire (Mini AQLQ) scores at the end of the study period compared to patients that are in the control group and do not increase daily step counts.
Participants will be randomized into the two groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Control group (usual care group) of 75 patients will not participate in the intervention but will take an asthma control survey at baseline (point of enrollment into the study) and about 4-6 weeks after.
The Intervention group of 75 patients who will participate in the intervention of step counts and take an asthma control survey at baseline (point of enrollment into the study) and about 4-6 weeks after.
Study Type
Interventional
Enrollment (Actual)
15
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
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Pennsylvania
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Wilkes-Barre, Pennsylvania, United States, 18702
- Geisinger South Wilkes-Barre Primary Care Clinic
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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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients within the Geisinger South Wilkes-Barre Primary Care clinic with a diagnosis of mild to moderate asthma
Exclusion Criteria:
- Patients with any medical history which would prohibit their ability to participate in increased exercise, and/or patients that are diagnosed or associated with severe asthma
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
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Active Comparator: Intervention Group
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Intervention group participants will be enrolled in a standardized step-based program to gradually increase their physical activity.
Daily steps will be measured via a pedometer application on a smartphone or wearable device, with a gradual increase in the goal on a weekly basis, with a target intervention of around 4-6 weeks in total.
The first week's step count will be used to calculate a baseline step count for the week.
At the start of each week, the participants will be asked to increase their daily step counts by 1,000.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Mini Asthma Quality of Life Questionnaire Score as a result of increased physical activity.
Time Frame: 6 weeks
|
Any improvement in the score will be considered an improvement, since other than physical activity changes via step counts no other pharmacologic or lifestyle intervention will be made.
Results will be compared to a control group who complete the survey without any intervention at two dates separated in time.
Improvement in asthma symptoms can improve quality of life for participants.
As noted by developers of the questionnaire being used in this study, "the Asthma Quality of Life Questionnaire has been developed to measure the functional (physical, emotional, occupational and social) problems that are most troublesome to adults with asthma … the impact that asthma has on a patient's quality of life cannot be inferred from the clinical indices."
Descriptive statistics including means, standard deviations, medians, and interquartile ranges for continuous variables and frequency counts and percentages for categorical variables will be presented.
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason Woloski, MD, Geisinger Clinic
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)
July 1, 2021
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
June 21, 2021
First Posted (Actual)
June 29, 2021
Study Record Updates
Last Update Posted (Actual)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0434
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.