Asthma in Young AdultsNCT04944199
Asthma Control: Increased Physical Activity in Young Adults
A study testing Physical Activity in people with Asthma in Young Adults, run by Geisinger Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Young Adults
- What is being tested?
- Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients within the Geisinger South Wilkes-Barre Primary Care clinic with a diagnosis of mild to moderate asthma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger South Wilkes-Barre Primary Care Clinic
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma in Young Adults
- Being tested
- Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Active comparator | Not described Receives: Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2021
- Primary completion31 Jul 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in Young AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Woloski, Geisinger Clinic
- Investigators
- Jason Woloski, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944199
- Sponsor's protocol ID
- 2021-0434
- Status last verified
- Aug 2022
- First submitted
- 21 Jun 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Increased Physical Activity in Young Adult Asthmatic Patients on Patient Perception of Pulmonary Health and Exercise
- ClinicalTrials.gov ID
- NCT04944199
- Acronym / sponsor ID
- 2021-0434
- Conditions
- Asthma in Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Active comparator | Other: Physical Activity |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients within the Geisinger South Wilkes-Barre Primary Care clinic with a diagnosis of mild to moderate asthma
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityIntervention 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. | Other | Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Woloski, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Asthma in Young Adults, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mini Asthma Quality of Life Questionnaire Score as a result of increased physical activity. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.