Atrial FibrillationNCT05450731
Cardiac Rehab Post-atrial Fib Ablation
A study testing 12-week supervised exercise based cardiac rehabilitation program in people with Atrial Fibrillation, run by MultiCare Health System Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 12-week supervised exercise based cardiac rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2022to 13 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● 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).
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- 12-week supervised exercise based cardiac rehabilitation program
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week supervised exercise based cardiac rehabilitation programOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the first intake appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start14 May 2022
- Primary completion14 Jun 2023
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MultiCare Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450731
- Sponsor's protocol ID
- 2022/05/04
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiac Rehabilitation Exercise on the Recurrence of Atrial Fibrillation in Post-ablation Patients: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05450731
- Acronym / sponsor ID
- 2022/05/04
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MultiCare Health System Research InstituteUniversity, hospital or other
- Study start
- 14 May 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiac rehabilitation intervention group | Experimental | Other: 12-week supervised exercise based cardiac rehabilitation programParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ● Adult patients 18 years and older.
Key exclusion criteria (8 listed)
- ● Does not speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week supervised exercise based cardiac rehabilitation program12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure. | Other | cardiac rehabilitation intervention group |
Primary outcome
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.
Time frame: 12 months after the first intake appointment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Related trials for Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week supervised exercise based cardiac rehabilitation program in people with Atrial Fibrillation, run by MultiCare Health System Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months after the first intake appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.