Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05157568 |
| Other study ID # |
20210752-01H |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2022 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Ottawa Heart Institute Research Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
