AsthmaSTAPLENCT06150300
Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.
A study testing Pulmonary rehab program in people with Asthma, run by University of Saskatchewan.
Trial summary
This is a randomized control trial evaluating the effect of a novel mobile application-delivered pulmonary rehabilitation program in adult severe asthma patients. The intervention will include eight weeks of exercise videos that progress in difficulty, as well as asthma-specific educational content. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Pulmonary rehab program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older with a diagnosis of asthma by a respirologist. They must have severe disease defined by GINA severity classification. Participants must have access to a smartphone or internet browser to allow access to study content.
Who cannot join
- Exclusion criteria include comorbid cardiopulmonary or musculoskeletal conditions that may impact exercise tolerance in accordance with the American Thoracic Society CPET guidelines
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: STAPLE (Severe asThmA PuLmonary rEhab): Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.
This is a randomized control trial evaluating the effect of a novel mobile application-delivered pulmonary rehabilitation program in adult severe asthma patients. The intervention will include eight weeks of exercise videos that progress in difficulty, as well as asthma-specific educational content. The primary outcome measure is change in functional exercise capacity as measured by six-minute walk distance. Secondary outcome measures will include evaluation of overall feasibility, and change in CPET parameters such as VO2max. Change in asthma control questionnaire (ACQ), asthma quality of life questionnaire (AQLQ) and PRAISE self-efficacy score will also be evaluated.
- Conditions
- Asthma
- Being tested
- Pulmonary rehab program, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehab programBehavioural
Exercise videos, breathing exercises, and educational messages delivered virtually
PlaceboBehavioural
Breathing exercises and educational messages
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Active comparator | 8 week virtual pulmonary rehab program including breathing exercises and educational messages. Receives: Behavioral: Pulmonary rehab program |
| Placebo | Placebo comparator | Breathing exercises and educational messages Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPET
VO2max
Measured: After 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brianne Philipenko, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150300
- Sponsor's protocol ID
- Bio4357
- Acronym
- STAPLE
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAPLE (Severe asThmA PuLmonary rEhab): Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.
- ClinicalTrials.gov ID
- NCT06150300
- Acronym / sponsor ID
- STAPLE / Bio4357
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2023 (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.
This is a randomized control trial evaluating the effect of a novel mobile application-delivered pulmonary rehabilitation program in adult severe asthma patients. The intervention will include eight weeks of exercise videos that progress in difficulty, as well as asthma-specific educational content. The primary outcome measure is change in functional exercise capacity as measured by six-minute walk distance. Secondary outcome measures will include evaluation of overall feasibility, and change in CPET parameters such as VO2max. Change in asthma control questionnaire (ACQ), asthma quality of life questionnaire (AQLQ) and PRAISE self-efficacy score will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Active comparator | Behavioral: Pulmonary rehab program8 week virtual pulmonary rehab program including breathing exercises and educational messages. |
| Placebo | Placebo comparator | Behavioral: PlaceboBreathing exercises and educational messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years and older with a diagnosis of asthma by a respirologist. They must have severe disease defined by GINA severity classification. Participants must have access to a smartphone or internet browser to allow access to study content.
Key exclusion criteria (1 listed)
- Exclusion criteria include comorbid cardiopulmonary or musculoskeletal conditions that may impact exercise tolerance in accordance with the American Thoracic Society CPET guidelines
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 |
|---|---|---|
| Pulmonary rehab programExercise videos, breathing exercises, and educational messages delivered virtually | Behavioural | Physical activity intervention |
| PlaceboBreathing exercises and educational messages | Behavioural | Placebo |
Primary outcome
CPET
Time frame: After 8 weeks of intervention
VO2max
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehab program in people with Asthma, run by University of Saskatchewan.
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: opening soon, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brianne Philipenko, MD (306-956-3444, bsp943@mail.usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPET (time frame: After 8 weeks of intervention). 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 29 Nov 2023.