NCT05820776

Brief Summary

Pulmonary rehabilitation is a program that helps people with lung disease improve their function. It uses exercise, education, and self-management strategies to improve physical ability and quality of life. Because some people are unable to visit West Park Healthcare Centre, we established a remote supervised pulmonary rehabilitation program that patients can access via an electronic device (computer, tablet or smart phone). Regular quality assurance is necessary to ensure that the program is effective. We plan to collect and summarize the program's results. The benefit of doing so is that it allows us to make any changes or improvements that may help patients with chronic respiratory conditions.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

April 6, 2023

Last Update Submit

July 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • health-related quality of life Chronic Respiratory Questionnaire - dyspnea

    Disease-specific health-related quality of life questionnaire. Developed to measure the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's life.

    12 weeks

Secondary Outcomes (2)

  • 6-minute walk test distance

    12 weeks

  • 30-second Chair Stand Test

    12 weeks

Interventions

The intervention is PR delivered via a telemedicine. The intervention is PR delivered via a telemedicine. The program is delivered by the multidisciplinary via a remote application for two sessions per week for ten weeks. Remotely supervised exercise includes: 1) deep breathing reinforcing pursed lip and diaphragmatic breathing; 2) warm up breathing and stretching exercise; 3) a cardiorespiratory aerobic exercise battery; 4) resistance training, and; stretching cool down. There is also an educational component. The secondary (maintenance) program includes ongoing remotely supervised exercise and education once a week for six months (24 sessions). All patients successfully completing the initial PR are offered the maintenance program.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults diagnosed with chronic respiratory disease affecting the airways and other structures of the lungs causing dyspnea including chronic obstructive pulmonary disease (COPD), occupational lung diseases and pulmonary hypertension.

You may qualify if:

  • stable chronic respiratory disease
  • qualified candidates for pulmonary rehabilitation,
  • current non-smoker;
  • primary diagnosis chronic respiratory disease limited by dyspnea (mMRC≥2);
  • free of exacerbation at the time of admission, and
  • stable co-existing conditions

You may not qualify if:

  • completed PR within the previous 12 months of the current admission and
  • being unable to communicate with the treating team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

RECRUITING

Study Officials

  • Roger Goldstein, MD

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Office Supervisor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Program in Respiratory Rehabilitation

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 20, 2023

Study Start

April 6, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations