Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary rehab program, Placebo.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
STAPLE (Severe asThmA PuLmonary rEhab): Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.
Overview
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.
Interventions
- Behavioral Pulmonary rehab program
Exercise videos, breathing exercises, and educational messages delivered virtually - Behavioral Placebo
Breathing exercises and educational messages
Primary outcome measures
- CPET [Time frame: After 8 weeks of intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06150300 · Bio4357