To investigate in our defined HF patient population if monitoring in combination with motivation on physical activity leads to an increase in enrollment rate for cardiac rehabilitation and sustained physical activity after cardiac rehabilitation as…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in distance on the 6 minute walk test over the study period
between intervention and control arm.
Secondary outcome
1) The difference of daily amount of steps after CR between intervention and
control arm.
2) The difference in CR enrolment after referral by the cardiologist between
intervention and control arm.
3) Hospitalization and mortality
4) Health related quality of life
5) Physical fitness
6) Mental health
7) Fear of movement
8) Compliance to program
9) (S)AE
Background summary
Heart failure is a severe chronic disease with a great health care burden.
Frequent (re-)hospitalizations and a high mortality remain an important issue.
Optimal medical treatment (OMT) and lifestyle changes such as increased
physical activity (PA) are the cornerstones of treatment. Based on the European
Society for Cardiology (ESC) guidelines, regular aerobic exercise, for example
within a centre-based cardiac rehabilitation (CR) is recommended for all Heart
Failure patients with reduced Ejection Fraction (HFrEF) patients. Several
studies have shown that PA is just as effective as medical therapy and can
lower hospital admissions and decrease mortality. However, physical activity in
this group of patients is challenging as both low participation rates for CR
and relapse to low physical activity levels after CR are major issues. This
study aims to demonstrate that monitoring physical activity in combination with
motivational feedback benefits the level of participation in centre-based CR
and, hence, the outcomes for these HF patients.
Study objective
To investigate in our defined HF patient population if monitoring in
combination with motivation on physical activity leads to an increase in
enrollment rate for cardiac rehabilitation and sustained physical activity
after cardiac rehabilitation as measured by the 6MWT.
Study design
The proposed study is a randomized controlled trial with a follow-up of at
least 6 months. A total of 180 patients will be randomized to 2 arms in a 2:1
fashion: (1) Physical activity monitoring device with feedback and motivation;
(2) Physical activity monitoring device without feedback and motivation. Both
arms will have standard of care (SoC), including standard cardiac
rehabilitation (specific for HF) according to the Dutch guidelines along with
OMT as prescribed by the treating physician. The enrolment period will be 12
months. Additional measurements will take place at 3 time points: at baseline
(within 6 weeks after inclusion), at the end of CR (16-20 weeks after
inclusion) and at the end of follow-up (3 months after CR or at least 6 months
after inclusion).
Intervention
All patients in both arms of the study will wear an Actigraph activity tracker
for physical activity monitoring. In addition, only the intervention arm will
also wear a Fitbit smartwatch on which they will receive automated motivational
feedback based on a goal for physical activity (step count), set by the
treating physician before and after CR.
Study burden and risks
Patients will be included in the study during a regular visit at the outpatient
clinic and will wear an Actigraph activity tracker for three short, defined
periods during the study: the first week after inclusion, 1 week at the end of
CR combined with 1 week after CR and 1 week at the end of follow-up. Only the
patients randomized to the intervention arm will additionally and continuously
wear a Fitbit smartwatch during the entire study period. On this watch, they
can see their current step count with the daily goal and receive feedback on
it.
There will be 3 regular visits at the outpatient clinic, at inclusion, after
completed CR or 16-17 weeks after inclusion (irrespective of completion CR in
case of non-participation or early drop-out) and at the end of follow-up.
During these visits, the following tests will be done: six-minute walk test and
grip strength test. This set of tests will take 30-45 minutes. In addition,
participants are asked to fill out questionnaires through an online portal at
home (20 min) three times during the study period. A similar set and frequency
of tests was found to be feasible in earlier activity monitoring studies from
our group (OPTICARE 1 and OPTICARE XL).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18 years, * 85 years.
2. Patients with chronic HFrEF (ischaemic or non-ischaemic) from the
outpatient clinic.
3. NYHA class II/III.
4. Indication for and referral to CR (first time or last CR was more than 1
year before inclusion).
5. Clinically stable (no hospitalization in the month prior to inclusion).
6. The patient should be willing and able to cooperate with study procedure
(use activity tracker/device, fill out questionnaires, comply with the required
follow-up visits and sign informed consent.
7. Sufficient understanding of Dutch language, both spoken and written.
8. Access to a smartphone with SMS functionality and a personal computer with
internet access and an email address.
Exclusion criteria
1. Patients with acute HF, HFpEF or HFmEF.
2. Patients who are currently or have been (< 1 month) hospitalized.
3. End stage renal disease requiring dialysis.
4. Other comorbidities precluding exercise training.
5. Patients with a life expectancy <1 year.
6. Patients on the waiting list for a heart transplant.
7. Patients already using their own activity tracking device.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68986.078.19 |
| OMON | NL-OMON24242 |