Cardiac Rehab Post-atrial Fib Ablation

NCT ID: NCT05450731

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-14

Study Completion Date

2024-01-13

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

12-week supervised exercise based cardiac rehabilitation program

Intervention Type 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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MultiCare Health System Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tacoma General Hospital

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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2022/05/04

Identifier Type: -

Identifier Source: org_study_id

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