NCT04092166

Brief Summary

The objective of this study is to determine whether participation in an 8-week structured cardiac rehabilitation program can increase cardiorespiratory fitness in patients with atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

4 years

First QC Date

July 3, 2019

Last Update Submit

February 2, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients?

    The primary endpoint of the study is to determine whether engagement with an 8-week, 24- session cardiac rehabilitation program can increase exercise capacity by 2 METS, a threshold that has previously been shown to improve patient outcomes.

    1 year

Study Arms (2)

Controlled

NO INTERVENTION

Participants will have no intervention.

Cardiac Rehab Exercise: Stationary Bike

OTHER

Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).

Other: Stationary Bike

Interventions

Stationary BikeOTHER

Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).

Cardiac Rehab Exercise: Stationary Bike

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Individuals with paroxysmal or persistent AF
  • Individuals with a BMI between 27 and 40

You may not qualify if:

  • Inability to engage with a cardiac rehabilitation program
  • Pregnant women
  • If patient can perform exercise at a high intensity (6 METS or above), they will no longer be analyzed in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Suneet Mittal, MD

    The Valley Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 1:1 Randomization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

September 17, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)