COPDVERTEXNCT05045209
Virtual Exercise Rehabilitation Treatment Program for Post Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Virtual rehabilitation
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Admitted patients >40years of age with documented diagnosis of COPD
Who may be able to join
- minimum age of 18 years
- maximum age of 90 years
- diagnosis of COPD
Who cannot join
- inability to perform exercise
- severe debilitating conditions
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Josephs' Hospital, Hamilton
Hamilton, Ontario, L8N 4A6
Nima Makhdami, 6475321431, makhdamn@mcmaster.ca
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Virtual rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual rehabilitationOther
Patient who are assigned to this group will receive virtual rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test distance
The distance walked during the 6 minute
Measured: 1 year
1-MSTST
One-minute sit to stand test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Natya Raghavan, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045209
- Sponsor's protocol ID
- 13451
- Acronym
- VERTEX
- Status last verified
- Nov 2022
- First submitted
- 5 Sep 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Exercise Rehabilitation Treatment Program for Post Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05045209
- Acronym / sponsor ID
- VERTEX / 13451
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual rehabilitation | – | Other: Virtual rehabilitationVirtual pulmonary rehabilitation will be provided by a tablet with connection to a physiotherapist for monitored exercise sessions with educational videos provided on the tablet. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients >40years of age with documented diagnosis of COPD
Key inclusion criteria (3 listed)
- minimum age of 18 years
- maximum age of 90 years
- diagnosis of COPD
Key exclusion criteria (2 listed)
- inability to perform exercise
- severe debilitating conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual rehabilitationPatient who are assigned to this group will receive virtual rehabilitation | Other | Virtual rehabilitation |
Primary outcome
6 minute walk test distance
Time frame: 1 year
The distance walked during the 6 minute
1-MSTST
Time frame: 1 year
One-minute sit to stand test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natya Raghavan, MDCM (905-521-2100 ext. 44548, raghanat@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test distance (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.