Virtual Exercise Rehabilitation Treatment Program for Post Exacerbation of Chronic Obstructive Pulmonary Disease (VERTEX)

November 9, 2022 updated by: Natya Raghavan, St. Joseph's Healthcare Hamilton
Respiratory rehabilitation is an intervention proven to improve quality of life in those with chronic lung disease but access remains poor. The investigators will assess the feasibility and acceptability of a virtual platform for respiratory rehabilitation as an alternative to in person rehabilitation. The aim is to use the technology in those post admission with COPD where access has been even more of a challenge as during this period patients find it difficult to access an out patient program due to their frailty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

People living with lung disease struggle with activities. An exercise program can help but these programs are limited and are hard to get to and generally have a long wait list. The investigators will offer exercise and education through a tablet with internet provided 2 times per week for 10 weeks for patients admitted to hospital with a worsening of their COPD. Patients will work with a trained therapist for the exercise sessions and with the team for the education sessions. The investigators will assess outcomes on functional and quality of life improvements as well as feasibility and scalability of the technology.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natya Raghavan, MDCM
  • Phone Number: 44548 905-521-2100
  • Email: raghanat@hhsc.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Josephs' Hospital, Hamilton
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Admitted patients >40years of age with documented diagnosis of COPD

Description

Inclusion Criteria:

  • minimum age of 18 years
  • maximum age of 90 years
  • diagnosis of COPD

Exclusion Criteria:

  • inability to perform exercise
  • severe debilitating conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Virtual rehabilitation
Virtual pulmonary rehabilitation will be provided by a tablet with connection to a physiotherapist for monitored exercise sessions with educational videos provided on the tablet.
Other: Virtual rehabilitation
Patient who are assigned to this group will receive virtual rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minute walk test distance
Time Frame: 1 year
The distance walked during the 6 minute
1 year
1-MSTST
Time Frame: 1 year
One-minute sit to stand test
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily activity levels
Time Frame: 1 year
Measured by step counts
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Boeringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 5, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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