Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population. (STAPLE)

University of Saskatchewan

Status: Not yet enrolling

Conditions: Asthma

Treatments: Behavioral: Pulmonary rehab program; Behavioral: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06150300

Bio4357

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups, including a placebo group

Physical activity intervention

Active Comparator group

Description:

8 week virtual pulmonary rehab program including breathing exercises and educational messages.

Treatment:

Behavioral: Pulmonary rehab program

Placebo

Placebo Comparator group

Description:

Breathing exercises and educational messages

Treatment:

Behavioral: Placebo