Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04092166 |
| Other study ID # |
18.0090 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
February 2022 |
| Source |
Valley Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to determine whether participation in an 8-week structured
cardiac rehabilitation program can increase cardiorespiratory fitness in patients with atrial
fibrillation.
Description:
The study is a randomized, prospective single center study to assess the utility and efficacy
of cardiac rehabilitation in patients with AF. All participants will receive the same medical
care and standard baseline education which includes an hour long one on one session with a
nutritionist.
Participants will also receive the guide book, Lifestyle Guide to Healing the Heart, at their
baseline visit as part of their education
After obtaining informed consent to participate in the study and signing a consent form to
participate in the Phase 3 cardiac rehabilitation program, participants will undergo a
baseline assessment of their functional status using the functional capacity NuStep test. The
NuStep test will be conducted at the Valley Hospital at baseline and after 8 weeks using the
NuStep TRS 4000 machine - a stationary bike machine that also engages one's arms by pushing
and pulling arm handles. Participants will sit in the NuStep machine and bike on level 4 (a
low to moderate level) for 6 minutes, if possible. However, participants will be encouraged
to step as quickly as possible during this time period. Participants will be asked about any
discomfort before, during and after the test. The participant's METS are calculated directly
by the machine based on the watts while exercising.
The degree of improvement of the participant's METS over the course of the 8-week program
will produce a greater understanding of the effect of a structured cardiac rehabilitation
program on cardiorespiratory fitness.
Following this baseline assessment, participants will then be randomized to undergo usual
care or an 8-week (24-session) Phase 3 cardiac rehabilitation program at the Valley Health
System Center for Health & Wellness in Mahwah. Eight weeks later, participants will undergo
repeat assessment of functional status.
In addition, participants will be administered the Atrial Fibrillation Effect on
Quality-of-life (AFEQT) survey at baseline, 6-months and 12-months later.
Patients will also undergo a 1-week Zio XT Holter monitor at the same time points (baseline,
6-months and 12-months). The Zio XT Holter monitor is a small, discreet comfortable patch
that sticks on a participant's chest to test for any arrhythmias, such as AF duration and
burden. The Zio XT Holter monitor will be available through commercial (HIPAA-compliant)
remote monitoring portals and will not be stored locally in Valley Health System. However, in
the future this may change and the Zio XT Holter monitor data will be stored as part of the
participant's electronic medical record.
