Atrial FibrillationNCT04092166
Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation
A study testing Stationary Bike in people with Atrial Fibrillation, run by Valley Health System at 1 site in United States.
Trial 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. 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?
- Stationary Bike
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 27 Feb 2025
- 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
- Age ≥ 18 years
- Individuals with paroxysmal or persistent AF
- Individuals with a BMI between 27 and 40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study is a randomized, prospective single center study to assess the utility and efficacy of cardiac rehabilitation in patients with AF. All participants will receive the same medical care and standard baseline education which includes an hour long one on one session with a nutritionist.
Participants will also receive the guide book, Lifestyle Guide to Healing the Heart, at their baseline visit as part of their education
After obtaining informed consent to participate in the study and signing a consent form to participate in the Phase 3 cardiac rehabilitation program, participants will undergo a baseline assessment of their functional status using the functional capacity NuStep test. The NuStep test will be conducted at the Valley Hospital at baseline and after 8 weeks using the NuStep TRS 4000 machine - a stationary bike machine that also engages one's arms by pushing and pulling arm handles. Participants will sit in the NuStep machine and bike on level 4 (a low to moderate level) for 6 minutes, if possible. However, participants will be encouraged to step as quickly as possible during this time period. Participants will be asked about any discomfort before, during and after the test. The participant's METS are calculated directly by the machine based on the watts while exercising.
The degree of improvement of the participant's METS over the course of the 8-week program will produce a greater understanding of the effect of a structured cardiac rehabilitation program on cardiorespiratory fitness.
Following this baseline assessment, participants will then be randomized to undergo usual care or an 8-week (24-session) Phase 3 cardiac rehabilitation program at the Valley Health System Center for Health \& Wellness in Mahwah. Eight weeks later, participants will undergo repeat assessment of functional status.
In addition, participants will be administered the Atrial Fibrillation Effect on Quality-of-life (AFEQT) survey at baseline, 6-months and 12-months later.
Patients will also undergo a 1-week Zio XT Holter monitor at the same time points (baseline, 6-months and 12-months). The Zio XT Holter monitor is a small, discreet comfortable patch that sticks on a participant's chest to test for any arrhythmias, such as AF duration and burden. The Zio XT Holter monitor will be available through commercial (HIPAA-compliant) remote monitoring portals and will not be stored locally in Valley Health System. However, in the future this may change and the Zio XT Holter monitor data will be stored as part of the participant's electronic medical record.
- Conditions
- Atrial Fibrillation
- Being tested
- Stationary Bike
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start1 May 2019
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 Randomization
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suneet Mittal, MD, Principal investigator, The Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092166
- Sponsor's protocol ID
- 18.0090
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2019
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Structured Cardiac Rehabilitation Program on Cardiorespiratory Fitness in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04092166
- Acronym / sponsor ID
- 18.0090
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 17 Sep 2019 (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 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.
Detailed description
The study is a randomized, prospective single center study to assess the utility and efficacy of cardiac rehabilitation in patients with AF. All participants will receive the same medical care and standard baseline education which includes an hour long one on one session with a nutritionist.
Participants will also receive the guide book, Lifestyle Guide to Healing the Heart, at their baseline visit as part of their education
After obtaining informed consent to participate in the study and signing a consent form to participate in the Phase 3 cardiac rehabilitation program, participants will undergo a baseline assessment of their functional status using the functional capacity NuStep test. The NuStep test will be conducted at the Valley Hospital at baseline and after 8 weeks using the NuStep TRS 4000 machine - a stationary bike machine that also engages one's arms by pushing and pulling arm handles. Participants will sit in the NuStep machine and bike on level 4 (a low to moderate level) for 6 minutes, if possible. However, participants will be encouraged to step as quickly as possible during this time period. Participants will be asked about any discomfort before, during and after the test. The participant's METS are calculated directly by the machine based on the watts while exercising.
The degree of improvement of the participant's METS over the course of the 8-week program will produce a greater understanding of the effect of a structured cardiac rehabilitation program on cardiorespiratory fitness.
Following this baseline assessment, participants will then be randomized to undergo usual care or an 8-week (24-session) Phase 3 cardiac rehabilitation program at the Valley Health System Center for Health \& Wellness in Mahwah. Eight weeks later, participants will undergo repeat assessment of functional status.
In addition, participants will be administered the Atrial Fibrillation Effect on Quality-of-life (AFEQT) survey at baseline, 6-months and 12-months later.
Patients will also undergo a 1-week Zio XT Holter monitor at the same time points (baseline, 6-months and 12-months). The Zio XT Holter monitor is a small, discreet comfortable patch that sticks on a participant's chest to test for any arrhythmias, such as AF duration and burden. The Zio XT Holter monitor will be available through commercial (HIPAA-compliant) remote monitoring portals and will not be stored locally in Valley Health System. However, in the future this may change and the Zio XT Holter monitor data will be stored as part of the participant's electronic medical record.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 Randomization
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Individuals with paroxysmal or persistent AF
- Individuals with a BMI between 27 and 40
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Stationary BikeParticipants 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 | – |
Primary outcome
Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients?
Time frame: 1 year
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.
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Suneet Mittal, MD principal investigator
The Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stationary Bike in people with Atrial Fibrillation, run by Valley Health System 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 3 inclusion and 3 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 9 Jun 2026. 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?
Will a cardiac rehab program increase cardiorespiratory fitness in Afib patients? (time frame: 1 year). 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 9 Jun 2026.