Cardiac DiseaseVirtualEXNCT05157568
Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation
A study testing Exercise Streaming (ES) and Exercise Streaming + Equipment (ES+E) in people with Cardiac Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Exercise Streaming (ES) and Exercise Streaming + Equipment (ES+E)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient was discharged from hospitalized at UOHI within the last 12 weeks;
- Patient has stable CHD or repaired valvular disease;
- Patient has been referred to CR and is a candidate an offsite program;
- Patient is able to completed a cardiopulmonary exercise test;
- Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
- Patient is ≥ 18 years of age (the age of consent in Ontario);
- Patient is able to provide informed consent
Who cannot join
- Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
- Patient, in the opinion of the medical advisor (Dr. Andrew Pipe/Dr. Hassan Mir), manifests illness or disease that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence, unresolved cardiac symptoms).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rethinking Post-acute Cardiac Care: Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation
Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. Technological advances in video-conferencing and video-streaming are affording new opportunities to increase access to CR services and supervised exercise sessions for patients who are social distancing, or who face access issues (e.g., time, mobility, transportation etc.). Comfort with these technologies for CR staff and patients has been accelerated by the current pandemic. Technology-enabled interactions between patients and providers is a significant opportunity to help mitigate these effects. We developed a new model for delivery of group exercise training for people with heart disease. Our model delivers all the core components of CR (i.e. counseling, education, risk factor management) but also includes live-streaming of CR exercise classes. Two versions of these classes are available: one that does not require any exercise equipment; and one that relies on a stationary exercise bike and exercise band delivered and installed in patients' homes. The new model has performed well in proof-of-concept testing, but now needs to be rigorously evaluated.
Read the detailed description
Heart diseases affect an estimated 2 million Canadians each year; they are chronic conditions that require patients to manage their health on a daily basis. Moderate-to-vigorous intensity aerobic exercise (e.g. walking, running, cycling) is a key self-management strategy for people living with heart disease and those who accumulate at least 150 minutes of moderate-to-vigorous intensity physical activity (MVPA) each week improve critical patient-relevant outcomes like cardiorespiratory fitness, symptoms of anxiety and depression, quality of life, rehospitalization, and mortality.
Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. In Canada, many patients with heart disease do not access CR programs. Estimates of the proportion of patients with heart disease that attend CR range from 22-52% and a majority of them are men. Long travel distance to CR centres, severe weather, work and caregiving responsibilities, other time constraints, and the costs for parking while attending CR programs consistently top patient-related barriers to participation. In addition, the current COVID-19 pandemic has forced CR programs to limit participation in on-site activities, significantly impacting the ability to provide exercise testing and supervised exercise training sessions, therapies known to improve outcomes. Many CR programs have switched to virtual care, a case-managed approach that is delivered by phone, email and/or the Internet. Participant feedback indicates drawbacks to home-based programming, including: a lack of social support (compared to on-site group exercise); a lack of instruction and feedback on exercise performance; a lack of appropriate home exercise equipment; and, a lack of structure for completing daily exercise sessions.
Technological advances in video-conferencing and video-streaming are affording new opportunities to increase access to CR services and supervised exercise sessions for patients who are social distancing, or who face access issues (e.g., time, mobility, transportation etc.). Comfort with these technologies for CR staff and patients has been accelerated by the current pandemic. Current and future pandemics are likely to feature waves of infection necessitating frequent and long periods of physical distancing, isolation, and healthcare disruption, particularly for vulnerable populations, such as those with heart disease. This will result in progressively poorer physical and mental health for people living with these conditions. Technology-enabled interactions between patients and providers is a significant opportunity to help mitigate these effects.
Few randomized controlled trials (RCT) of real-time, video-conferencing-based exercise rehabilitation have been conducted. A scoping review of digital cardiology applications did not include any video-conference-based supervised exercise interventions. We conducted literature searches using the terms 'video-conference,' 'randomized trial,' and 'exercise' and identified only 2 published studies. Tsai and colleagues randomized 37 patients with COPD to either a supervised, home-based tele-rehabilitation group that received exercise training via videoconference 3 times/week for 8 weeks, or a control group that received usual care without exercise training. After 8 weeks, participants in the intervention group showed a significant increase in endurance shuttle walk test time compared to participants in the control group (between group difference = 340 s; P <.0001) (7). Duruturk and Oskoslu randomized 50 participants with type 2 diabetes to treatment or control. Participants in the treatment group performed breathing and calisthenic exercises, three times a week, for 6 weeks, at home by Internet-based video conferences. HbA1c (P <.01), 6 min walking distance (P <.01), and depression levels (P <.01) changed significantly in the treatment versus the control group.
The incremental value of installing specific forms of home exercise equipment is also an important question. Proper equipment may allow people to increase the volume and intensity of their workouts, important drivers of adaptation to exercise and improvements in cardiorespiratory and functional fitness. We were able to locate only one RCT in patients with chronic illness that used provision of home exercise equipment as an independent variable. Jakicic et al examined the effects of home exercise equipment in 148 overweight women (9). Participants who had a treadmill installed in their home achieved greater weight loss (-7.4 kg vs. -3.7 kg; P <.05) and completed more exercise sessions each week in follow-up compared to participants receiving exercise coaching only (6.6 vs. 4.3 sessions per week; P <.05). Of note, the pandemic has accelerated adoption of home exercise equipment and exercise class streaming among healthy adults (e.g. Peloton, Mirror); none of these applications are designed to meet the needs of people with heart disease.
We developed a new model for delivery of group exercise training for people with heart disease. Our model delivers all the core components of CR (i.e. counseling, education, risk factor management) but also includes live-streaming of CR exercise classes. Two versions of these classes are available: one that does not require any exercise equipment; and one that relies on a stationary exercise bike and exercise band delivered and installed in patients' homes. The new model has performed well in proof-of-concept testing, but now needs to be rigorously evaluated.
- Conditions
- Cardiac Disease
- Being tested
- Exercise Streaming (ES), Exercise Streaming + Equipment (ES+E), Control
- Keywords
- Cardiovascular Rehabilitation, Virtual Rehabilitation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Streaming (ES)Behavioural
Participants will complete 8 weeks (1 class per week) of supervised exercise online. No equipment is required. They will follow a pre-recorded exercise video and at the same time, get instruction, feedback and support from their coach. Each class will be held as a teleconference.
Exercise Streaming + Equipment (ES+E)Behavioural
Participants will complete 8 weeks (1 class per week) of supervised exercise online. Each participant will have a stationary exercise bike delivered to their home for use during their live classes. They will follow a pre-recorded exercise video and at the same time, get instruction, feedback and support from their coach. Each class will be held as a teleconference.
ControlBehavioural
Participants will complete 8 weeks (1 class per week) of in-person supervised exercise.
| Study group | Role | What they receive |
|---|---|---|
| Control (C) | Active comparator | Participants will receive a exercise prescription and a home exercise plan. It will specify how many days per week they should exercise and will indicate how hard they should be working using their heart rate and rating of perceived exertion (RPE) as a guide. They will attend 8 onsite rehabilitation classes at the University of Ottawa Heart Institute (1 class per week for 8 weeks). These classes will be led by a specially trained instructor who will teach and encourage self-monitoring of heart rate and RPE. The class will include a warm-up, 30 minutes of aerobic exercise and a 15 min cool-down, including strength exercises and stretches. Following each class there will be a short mini-education session highlighting a variety of topics on how to manage risk factors. Patients will have access to onsite classes for nutrition and stress management. Participants will receive access to 8 additional educational videos that highlight topics such as exercise safety, goal setting and nutrition. Receives: Behavioral: Control |
| Exercise Streaming (ES) | Active comparator | Participants will complete 1 "live" virtual class per week for 8-weeks. Classes will be led by a specially trained instructor and will include a warm-up, 30 minutes of aerobic exercise, 10 minutes of strength exercises, and a cooldown and stretching segment. During each live class, the instructor will play the corresponding video and supervise the participants through the Zoom for Healthcare platform. Heart rates and RPE data will be collected from each participant. Participants will have access to other pre-recorded exercise videos that they can stream "on demand" at any time. They will be encouraged to access them "on demand" throughout the week. In addition participants will have access to the same 8 pre-recorded educational videos that the control group will receive. Topics include; exercise safety, goal setting, nutrition, stress management, medication information, risk factor awareness and transition planning. Receives: Behavioral: Exercise Streaming (ES) |
| Exercise Streaming + Equipment (ES+E) | Active comparator | Participants will receive an indoor bicycle and an exercise band (delivered and set up in their home). Participants will complete 1 "live" class per week for 8 weeks. Their exercise prescription will be based on a stress test. Classes will be led by a specially trained instructor and will include a warm-up, 30 minutes of aerobic exercise, 10 minutes of strength exercises, and a cooldown and stretching segment. During each "live" class, the exercise supervisor will play the corresponding video and supervise the participants through the Zoom for Healthcare platform. Heart rate and RPE data will be collected from each participant. Participants will have access to other pre-recorded exercise videos that they can stream "on demand" at any time. Participants will be encouraged to access them throughout the week. Participants will have access to the same 8 pre-recorded educational videos that the control and exercise streaming groups will receive. Receives: Behavioral: Exercise Streaming + Equipment (ES+E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility
What proportion of patients referred to CR are eligible to participate based on the inclusion and exclusion criteria?
Measured: 8 weeks
Feasibility of recruitment
What proportion of eligible patients accept the invitation to participate in the research and agree to be randomized to treatment?
Measured: 8 weeks
Feasibility of equipment delivery
Are the interventions acceptable in terms of completion of delivery and set-up of home exercise equipment (ES+E group only), scheduled coaching contacts, and exercise training class attendance (ES and ES+E groups)?
Measured: 8 weeks
Retention
How many patients will complete of follow-up assessments at the end of intervention (8 weeks)?
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start20 Sep 2022
- Primary completion24 Feb 2023
- Study completion1 Sep 2023
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thais Coutinho, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157568
- Sponsor's protocol ID
- 20210752-01H
- Acronym
- VirtualEX
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2021
- Last updated
- 13 Nov 2023
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rethinking Post-acute Cardiac Care: Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation
- ClinicalTrials.gov ID
- NCT05157568
- Acronym / sponsor ID
- VirtualEX / 20210752-01H
- Conditions
- Cardiac Disease
- Keywords
- Cardiovascular Rehabilitation, Virtual Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Dec 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.
Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. Technological advances in video-conferencing and video-streaming are affording new opportunities to increase access to CR services and supervised exercise sessions for patients who are social distancing, or who face access issues (e.g., time, mobility, transportation etc.). Comfort with these technologies for CR staff and patients has been accelerated by the current pandemic. Technology-enabled interactions between patients and providers is a significant opportunity to help mitigate these effects. We developed a new model for delivery of group exercise training for people with heart disease. Our model delivers all the core components of CR (i.e. counseling, education, risk factor management) but also includes live-streaming of CR exercise classes. Two versions of these classes are available: one that does not require any exercise equipment; and one that relies on a stationary exercise bike and exercise band delivered and installed in patients' homes. The new model has performed well in proof-of-concept testing, but now needs to be rigorously evaluated.
Detailed description
Heart diseases affect an estimated 2 million Canadians each year; they are chronic conditions that require patients to manage their health on a daily basis. Moderate-to-vigorous intensity aerobic exercise (e.g. walking, running, cycling) is a key self-management strategy for people living with heart disease and those who accumulate at least 150 minutes of moderate-to-vigorous intensity physical activity (MVPA) each week improve critical patient-relevant outcomes like cardiorespiratory fitness, symptoms of anxiety and depression, quality of life, rehospitalization, and mortality.
Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. In Canada, many patients with heart disease do not access CR programs. Estimates of the proportion of patients with heart disease that attend CR range from 22-52% and a majority of them are men. Long travel distance to CR centres, severe weather, work and caregiving responsibilities, other time constraints, and the costs for parking while attending CR programs consistently top patient-related barriers to participation. In addition, the current COVID-19 pandemic has forced CR programs to limit participation in on-site activities, significantly impacting the ability to provide exercise testing and supervised exercise training sessions, therapies known to improve outcomes. Many CR programs have switched to virtual care, a case-managed approach that is delivered by phone, email and/or the Internet. Participant feedback indicates drawbacks to home-based programming, including: a lack of social support (compared to on-site group exercise); a lack of instruction and feedback on exercise performance; a lack of appropriate home exercise equipment; and, a lack of structure for completing daily exercise sessions.
Technological advances in video-conferencing and video-streaming are affording new opportunities to increase access to CR services and supervised exercise sessions for patients who are social distancing, or who face access issues (e.g., time, mobility, transportation etc.). Comfort with these technologies for CR staff and patients has been accelerated by the current pandemic. Current and future pandemics are likely to feature waves of infection necessitating frequent and long periods of physical distancing, isolation, and healthcare disruption, particularly for vulnerable populations, such as those with heart disease. This will result in progressively poorer physical and mental health for people living with these conditions. Technology-enabled interactions between patients and providers is a significant opportunity to help mitigate these effects.
Few randomized controlled trials (RCT) of real-time, video-conferencing-based exercise rehabilitation have been conducted. A scoping review of digital cardiology applications did not include any video-conference-based supervised exercise interventions. We conducted literature searches using the terms 'video-conference,' 'randomized trial,' and 'exercise' and identified only 2 published studies. Tsai and colleagues randomized 37 patients with COPD to either a supervised, home-based tele-rehabilitation group that received exercise training via videoconference 3 times/week for 8 weeks, or a control group that received usual care without exercise training. After 8 weeks, participants in the intervention group showed a significant increase in endurance shuttle walk test time compared to participants in the control group (between group difference = 340 s; P <.0001) (7). Duruturk and Oskoslu randomized 50 participants with type 2 diabetes to treatment or control. Participants in the treatment group performed breathing and calisthenic exercises, three times a week, for 6 weeks, at home by Internet-based video conferences. HbA1c (P <.01), 6 min walking distance (P <.01), and depression levels (P <.01) changed significantly in the treatment versus the control group.
The incremental value of installing specific forms of home exercise equipment is also an important question. Proper equipment may allow people to increase the volume and intensity of their workouts, important drivers of adaptation to exercise and improvements in cardiorespiratory and functional fitness. We were able to locate only one RCT in patients with chronic illness that used provision of home exercise equipment as an independent variable. Jakicic et al examined the effects of home exercise equipment in 148 overweight women (9). Participants who had a treadmill installed in their home achieved greater weight loss (-7.4 kg vs. -3.7 kg; P <.05) and completed more exercise sessions each week in follow-up compared to participants receiving exercise coaching only (6.6 vs. 4.3 sessions per week; P <.05). Of note, the pandemic has accelerated adoption of home exercise equipment and exercise class streaming among healthy adults (e.g. Peloton, Mirror); none of these applications are designed to meet the needs of people with heart disease.
We developed a new model for delivery of group exercise training for people with heart disease. Our model delivers all the core components of CR (i.e. counseling, education, risk factor management) but also includes live-streaming of CR exercise classes. Two versions of these classes are available: one that does not require any exercise equipment; and one that relies on a stationary exercise bike and exercise band delivered and installed in patients' homes. The new model has performed well in proof-of-concept testing, but now needs to be rigorously evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (C) | Active comparator | Behavioral: ControlParticipants will receive a exercise prescription and a home exercise plan. It will specify how many days per week they should exercise and will indicate how hard they should be working using their heart rate and rating of perceived exertion (RPE) as a guide. They will attend 8 onsite rehabilitation classes at the University of Ottawa Heart Institute (1 class per week for 8 weeks). These classes will be led by a specially trained instructor who will teach and encourage self-monitoring of heart rate and RPE. The class will include a warm-up, 30 minutes of aerobic exercise and a 15 min cool-down, including strength exercises and stretches. Following each class there will be a short mini-education session highlighting a variety of topics on how to manage risk factors. Patients will have access to onsite classes for nutrition and stress management. Participants will receive access to 8 additional educational videos that highlight topics such as exercise safety, goal setting and nutrition. |
| Exercise Streaming (ES) | Active comparator | Behavioral: Exercise Streaming (ES)Participants will complete 1 "live" virtual class per week for 8-weeks. Classes will be led by a specially trained instructor and will include a warm-up, 30 minutes of aerobic exercise, 10 minutes of strength exercises, and a cooldown and stretching segment. During each live class, the instructor will play the corresponding video and supervise the participants through the Zoom for Healthcare platform. Heart rates and RPE data will be collected from each participant. Participants will have access to other pre-recorded exercise videos that they can stream "on demand" at any time. They will be encouraged to access them "on demand" throughout the week. In addition participants will have access to the same 8 pre-recorded educational videos that the control group will receive. Topics include; exercise safety, goal setting, nutrition, stress management, medication information, risk factor awareness and transition planning. |
| Exercise Streaming + Equipment (ES+E) | Active comparator | Behavioral: Exercise Streaming + Equipment (ES+E)Participants will receive an indoor bicycle and an exercise band (delivered and set up in their home). Participants will complete 1 "live" class per week for 8 weeks. Their exercise prescription will be based on a stress test. Classes will be led by a specially trained instructor and will include a warm-up, 30 minutes of aerobic exercise, 10 minutes of strength exercises, and a cooldown and stretching segment. During each "live" class, the exercise supervisor will play the corresponding video and supervise the participants through the Zoom for Healthcare platform. Heart rate and RPE data will be collected from each participant. Participants will have access to other pre-recorded exercise videos that they can stream "on demand" at any time. Participants will be encouraged to access them throughout the week. Participants will have access to the same 8 pre-recorded educational videos that the control and exercise streaming groups will receive. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient was discharged from hospitalized at UOHI within the last 12 weeks;
- Patient has stable CHD or repaired valvular disease;
- Patient has been referred to CR and is a candidate an offsite program;
- Patient is able to completed a cardiopulmonary exercise test;
- Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
Key exclusion criteria (2 listed)
- Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
- Patient, in the opinion of the medical advisor (Dr. Andrew Pipe/Dr. Hassan Mir), manifests illness or disease that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence, unresolved cardiac symptoms).
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 |
|---|---|---|
| Exercise Streaming (ES)Participants will complete 8 weeks (1 class per week) of supervised exercise online. No equipment is required. They will follow a pre-recorded exercise video and at the same time, get instruction, feedback and support from their coach. Each class will be held as a teleconference. | Behavioural | Exercise Streaming (ES) |
| Exercise Streaming + Equipment (ES+E)Participants will complete 8 weeks (1 class per week) of supervised exercise online. Each participant will have a stationary exercise bike delivered to their home for use during their live classes. They will follow a pre-recorded exercise video and at the same time, get instruction, feedback and support from their coach. Each class will be held as a teleconference. | Behavioural | Exercise Streaming + Equipment (ES+E) |
| ControlParticipants will complete 8 weeks (1 class per week) of in-person supervised exercise. | Behavioural | Control (C) |
Primary outcome
Eligibility
Time frame: 8 weeks
What proportion of patients referred to CR are eligible to participate based on the inclusion and exclusion criteria?
Feasibility of recruitment
Time frame: 8 weeks
What proportion of eligible patients accept the invitation to participate in the research and agree to be randomized to treatment?
Feasibility of equipment delivery
Time frame: 8 weeks
Are the interventions acceptable in terms of completion of delivery and set-up of home exercise equipment (ES+E group only), scheduled coaching contacts, and exercise training class attendance (ES and ES+E groups)?
Retention
Time frame: 8 weeks
How many patients will complete of follow-up assessments at the end of intervention (8 weeks)?
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Thais Coutinho, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Streaming (ES) and Exercise Streaming + Equipment (ES+E) in people with Cardiac Disease, run by Ottawa Heart Institute Research Corporation 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 7 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: stopped early, as of the sponsor's last update on 13 Nov 2023. 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?
The study was stopped early (reason given: Funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility (time frame: 8 weeks). The study lists 4 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 13 Nov 2023.