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

Sponsor

University of Saskatchewan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06150300

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Behavioral: Pulmonary rehab program Behavioral: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physical activity intervention 8 week virtual pulmonary rehab program including breathing exercises and educational messages.	Behavioral: Pulmonary rehab program Exercise videos, breathing exercises, and educational messages delivered virtually
Placebo Comparator: Placebo Breathing exercises and educational messages	Behavioral: Placebo Breathing exercises and educational messages

Arm

Intervention/Treatment

Active Comparator: Physical activity intervention

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

Behavioral: Pulmonary rehab program

Exercise videos, breathing exercises, and educational messages delivered virtually

Placebo Comparator: Placebo

Breathing exercises and educational messages

Behavioral: Placebo

Breathing exercises and educational messages

Outcome Measures

Primary Outcome Measures

CPET [After 8 weeks of intervention]
VO2max

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Saskatchewan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brianne Philipenko, Assistant Professor, MD FRCPC, University of Saskatchewan

ClinicalTrials.gov Identifier:

NCT06150300

Other Study ID Numbers:

Bio4357

First Posted:

Nov 29, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Nov 29, 2023