Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Stationary Bike

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controlled; Participants will have no intervention.
Other: Cardiac Rehab Exercise: Stationary Bike; 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).	Other: Stationary Bike; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Valley Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 18.0090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No