NCT04944199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

June 21, 2021

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

ACTIVE COMPARATOR
Other: Physical Activity

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients within the Geisinger South Wilkes-Barre Primary Care clinic with a diagnosis of mild to moderate asthma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger South Wilkes-Barre Primary Care Clinic

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jason Woloski, MD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor Family Medicine, Geisinger Commonwealth School of Medicine; Assistant Program Director, Geisinger Kistler Family Medicine Residency; Principal Investigator

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 29, 2021

Study Start

July 1, 2021

Primary Completion

July 31, 2021

Study Completion

April 30, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations