Cardiac Rehab Post-atrial Fib Ablation

Effect of Cardiac Rehabilitation Exercise on the Recurrence of Atrial Fibrillation in Post-ablation Patients: a Randomized Controlled Pilot Study

The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: 12-week supervised exercise based cardiac rehabilitation program

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Edwards, MS; Phone Number: 253-403-1058; Email: edwardsk@multicare.org

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98415
      • Tacoma General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ● Adult patients 18 years and older.

  • Willing to participate in the study after randomization to either an intervention group (cardiac rehabilitation exercise) or a control group (usual care).
  • Able to attend two pre and post study clinic visits at a local designated Pulse Heart Institute cardiac rehab program.
  • If randomized to the cardiac rehab intervention group can attend exercise rehab visits for 3 x per week for 12 weeks (36 visits) at a designated Pulse cardiac rehab program.
  • Has an active email address and phone number.
  • Documented diagnosis of Paroxysmal and persistent Atrial Fibrillation.
  • Undergone ablation treatment and is at a minimum of 2 weeks post ablation status.
  • Compliant with medication therapy including medications for heart rate control and anticoagulant(s).

Exclusion Criteria:

• ● Does not speak English.

  • Does not have clearance to participate in the study by their attending cardiologist.
  • Documented cardiovascular disease or pulmonary/respiratory disease that would qualify the patient for Cardiac, Pulmonary or Vascular Rehabilitation at a Pulse Heart Institute rehabilitation program.
  • Dementia or cognitive impairment.
  • Unable to participate in rehabilitation exercise due to physical limitations.
  • Greater than one prior ablation procedure
  • Long standing, chronic Atrial Fibrillation
  • Patients who have undergone posterior wall isolation ablation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cardiac rehabilitation intervention group; Participants assigned to the intervention group will participate in pre-post assessments and a 12-week supervised exercise based cardiac rehabilitation program at a designated local Pulse Heart Institute Cardiac Rehabilitation program.	Other: 12-week supervised exercise based cardiac rehabilitation program; 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.
No Intervention: control group; Participants assigned to the control group will participate in pre-post assessments and will maintain usual care and current activity levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in 40 patients at six- and twelve-months post-ablation procedure.	Examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation at 6- and 12-months post-ablation treatment.	12 months after the first intake appointment

Collaborators and Investigators

• Sponsor: MultiCare Health System Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2022
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): January 13, 2024

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

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: 2022/05/04

Drug and device information, study documents

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