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

NCT ID: NCT04092166

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-05-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Controlled

Participants will have no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: OTHER

Stationary Bike

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valley Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suneet Mittal, MD

Role: PRINCIPAL_INVESTIGATOR

The Valley Hospital

Locations

The Valley Hospital

Paramus, New Jersey, United States

Countries

United States

Other Identifiers

18.0090

Identifier Type: -

Identifier Source: org_study_id