Examining the Effects of a Remote Pulmonary Rehabilitatio... | NCT06150300

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

NCT06150300

Sponsor

University of Saskatchewan

Status

Not yet recruiting

Last Update Posted

Nov 29, 2023Actual

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Asthma

Interventions

Pulmonary rehab program
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 20, 2023

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brianne Philipenko, Assistant Professor, MD FRCPC, University of SaskatchewanPrincipal Investigator

Lead Sponsor

University of SaskatchewanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehab program	Behavioral	Exercise videos, breathing exercises, and educational messages delivered virtually	Physical activity intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPET	VO2max	After 8 weeks of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brianne Philipenko, MD	Contact	306-956-3444		bsp943@mail.usask.ca

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided