STAPLE (Severe asThmA PuLmonary rEhab): Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Saskatchewan
- Enrollment
- 34
- Primary Endpoint
- CPET
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Exclusion criteria include comorbid cardiopulmonary or musculoskeletal conditions that may impact exercise tolerance in accordance with the American Thoracic Society CPET guidelines
Arms & Interventions
Physical activity intervention
8 week virtual pulmonary rehab program including breathing exercises and educational messages.
Intervention: Pulmonary rehab program (Behavioral)
Placebo
Breathing exercises and educational messages
Intervention: Placebo (Behavioral)
Outcomes
Primary Outcomes
CPET
Time Frame: After 8 weeks of intervention
VO2max
Secondary Outcomes
No secondary outcomes reported
Investigators
Brianne Philipenko
Assistant Professor, MD FRCPC
University of Saskatchewan