Asthma Control: Increased Physical Activity in Young Adults

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: Asthma in Young Adults
• Intervention / Treatment: Other: Physical Activity

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

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Geisinger South Wilkes-Barre Primary Care Clinic

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Active Comparator: Intervention Group	Other: Physical Activity; 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.

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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Jason Woloski, MD, Geisinger Clinic

Study record dates

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: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• 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