Back to resultsCardiac Rehab Post-atrial Fib Ablation
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week supervised exercise based cardiac rehabilitation program
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- Tacoma General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cardiac rehabilitation intervention group
control group
Arm Description
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.
Participants assigned to the control group will participate in pre-post assessments and will maintain usual care and current activity levels.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05450731
First Posted
June 21, 2022
Last Updated
October 5, 2023
Sponsor
MultiCare Health System Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05450731
Brief Title
Cardiac Rehab Post-atrial Fib Ablation
Official Title
Effect of Cardiac Rehabilitation Exercise on the Recurrence of Atrial Fibrillation in Post-ablation Patients: a Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MultiCare Health System Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cardiac rehabilitation intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will participate in pre-post assessments and will maintain usual care and current activity levels.
Intervention Type
Other
Intervention Name(s)
12-week supervised exercise based cardiac rehabilitation program
Intervention Description
12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 months after the first intake appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Edwards, MS
Phone
253-403-1058
Email
edwardsk@multicare.org
Facility Information:
Facility Name
Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Edwards, MS
12. IPD Sharing Statement
Learn more about this trial
Cardiac Rehab Post-atrial Fib Ablation
We'll reach out to this number within 24 hrs