Cardiac Rehab Post-atrial Fib Ablation

NCT05450731 | Completed

• 1 other identifier: 2022/05/04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

cardiac rehabilitation intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

Participants assigned to the control group will participate in pre-post assessments and will maintain usual care and current activity levels.

Interventions

12-week supervised exercise based cardiac rehabilitation program OTHER

12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.

cardiac rehabilitation intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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).

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• MultiCare Health System Research Institute: lead

Study Sites (1)

Tacoma General Hospital

Tacoma, Washington, 98415, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 11, 2022
• Study Start: May 14, 2022
• Primary Completion: June 14, 2023
• Study Completion: January 13, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)