Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stationary Bike
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Individuals with paroxysmal or persistent AF
- Individuals with a BMI between 27 and 40
Exclusion Criteria:
- Inability to engage with a cardiac rehabilitation program
- Pregnant women
- If patient can perform exercise at a high intensity (6 METS or above), they will no longer be analyzed in the study
Sites / Locations
- The Valley Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Controlled
Cardiac Rehab Exercise: Stationary Bike
Arm Description
Participants will have no intervention.
Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).
Outcomes
Primary Outcome Measures
Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients?
The primary endpoint of the study is to determine whether engagement with an 8-week, 24- session cardiac rehabilitation program can increase exercise capacity by 2 METS, a threshold that has previously been shown to improve patient outcomes.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04092166
Brief Title
Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation
Official Title
Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valley Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Controlled
Arm Type
No Intervention
Arm Description
Participants will have no intervention.
Arm Title
Cardiac Rehab Exercise: Stationary Bike
Arm Type
Other
Arm Description
Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).
Intervention Type
Other
Intervention Name(s)
Stationary Bike
Intervention Description
Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).
Primary Outcome Measure Information:
Title
Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients?
Description
The primary endpoint of the study is to determine whether engagement with an 8-week, 24- session cardiac rehabilitation program can increase exercise capacity by 2 METS, a threshold that has previously been shown to improve patient outcomes.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Individuals with paroxysmal or persistent AF
Individuals with a BMI between 27 and 40
Exclusion Criteria:
Inability to engage with a cardiac rehabilitation program
Pregnant women
If patient can perform exercise at a high intensity (6 METS or above), they will no longer be analyzed in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suneet Mittal, MD
Organizational Affiliation
The Valley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation
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