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NCT06150300 Clinical Trial

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

Asthma Clinical Trial

— STAPLE  

Official title:
STAPLE (Severe asThmA PuLmonary rEhab): Examining the Effects of a Remote Pulmonary Rehabilitation Program in the Severe Asthma Population.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06150300
Other study ID # Bio4357
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2026

Study information
Verified date November 2023
Source University of Saskatchewan
Contact Brianne Philipenko, MD
Phone 306-956-3444
Email bsp943@mail.usask.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 34
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Pulmonary rehab program
Exercise videos, breathing exercises, and educational messages delivered virtually
• Placebo
Breathing exercises and educational messages

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Saskatchewan

Outcome
Type Measure Description Time frame Safety issue
Primary CPET VO2max After 8 weeks of intervention
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