NCT06150300

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable asthma

Timeline
8mo left

Started Jan 2024

Typical duration for not_applicable asthma

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

November 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 20, 2023

Last Update Submit

November 20, 2023

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • CPET

    VO2max

    After 8 weeks of intervention

Study Arms (2)

Physical activity intervention

ACTIVE COMPARATOR

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

Behavioral: Pulmonary rehab program

Placebo

PLACEBO COMPARATOR

Breathing exercises and educational messages

Behavioral: Placebo

Interventions

Pulmonary rehab programBEHAVIORAL

Exercise videos, breathing exercises, and educational messages delivered virtually

Physical activity intervention
PlaceboBEHAVIORAL

Breathing exercises and educational messages

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Brianne Philipenko, MD

CONTACT

306-956-3444bsp943@mail.usask.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD FRCPC

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 29, 2023

Study Start

January 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share