Back to resultsAsthma Control: Increased Physical Activity in Young Adults
Primary Purpose
Asthma in Young Adults
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
About this trial
This is an interventional other trial for Asthma in Young Adults
Eligibility Criteria
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
Sites / Locations
- Geisinger South Wilkes-Barre Primary Care Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Intervention Group
Arm Description
Outcomes
Primary Outcome Measures
Change in the Mini Asthma Quality of Life Questionnaire Score as a result of increased physical activity.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04944199
Brief Title
Asthma Control: Increased Physical Activity in Young Adults
Official Title
Impact of Increased Physical Activity in Young Adult Asthmatic Patients on Patient Perception of Pulmonary Health and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Young Adults
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Title
Intervention Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Mini Asthma Quality of Life Questionnaire Score as a result of increased physical activity.
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Woloski, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger South Wilkes-Barre Primary Care Clinic
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Asthma Control: Increased Physical Activity in Young Adults
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