Atrial FibrillationWHISH STARNCT05366803
Women's Health Initiative Silent Atrial Fibrillation Recording Study
A study testing Physical Activity in people with Atrial Fibrillation, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. Read more about this study
- Who is it for?
- Ages 65 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,257 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2017to 11 Feb 2020
- 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 65 to 100 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects already enrolled in the parent WHISH study.
- Subjects who are at high risk of developing atrial fibrillation.
Who cannot join
- Subjects who have had atrial fibrillation at baseline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study
The purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.
Read the detailed description
The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF. The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.
- Conditions
- Atrial Fibrillation
- Being tested
- Physical Activity
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | The Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time. The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials. The materials are based on the United States national guidelines for physical activity for older adults. Participants will wear the Zio patch monitor (electrocardiographic loop monitoring device) for 8 days at baseline, as well as at 6 months and again at one year, for a total of 3 times. Receives: Behavioral: Physical Activity |
| Usual Activity Control | No intervention | Participants will wear the Zio patch monitor (electrocardiographic loop monitoring device) for 8 days at baseline, as well as at 6 months and again at one year, for a total of 3 times. Participants carry about their normal activities during this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incidence of Atrial Fibrillation Due to Exercise
Measured: One year
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start8 Sep 2017
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Perez, Stanford University
- Investigators
- Marco Perez, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366803
- Sponsor's protocol ID
- 40082
- Acronym
- WHISH STAR
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gomez SE, Larson J, Hlatky MA, Kooperberg C, LaMonte M, Tinker L, Greenland P, Albert C, Froelicher V, Wheeler M, Stefanick ML, Perez MV. Women's health initiative strong and healthy silent atrial fibrillation recording study: Rationale, study design, and baseline data. Am Heart J. 2026 Oct;300:107478. doi: 10.1016/j.ahj.2026.107478. Epub 2026 May 8.
PubMed 42107553Lin JY, Larson J, Schoenberg J, Sepulveda A, Tinker L, Wheeler M, Albert C, Manson JE, Wells G, Martin LW, Froelicher V, LaMonte M, Kooperberg C, Hlatky MA, Greenland P, Stefanick ML, Perez MV. Serial 7-Day Electrocardiogram Patch Screening for AF in High-Risk Older Women by the CHARGE-AF Score. JACC Clin Electrophysiol. 2022 Dec;8(12):1523-1534. doi: 10.1016/j.jacep.2022.08.024. Epub 2022 Oct 26.
PubMed 36543503
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study
- ClinicalTrials.gov ID
- NCT05366803
- Acronym / sponsor ID
- WHISH STAR / 40082
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 9 May 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 purpose of the WHISH STAR study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ECG patch monitor. We will also study whether those with a known history of AF have any changes in AF hospitalizations due to exercise.
Detailed description
The Silent Atrial Fibrillation Recording study (STAR) study is an ancillary study of the NIH-funded Women's Health Initiative Strong and Healthy (WHISH). The purpose of the Women's Health Initiative Strong and Healthy study (WHISH) is to investigate if light to moderate exercise decreases incident atrial fibrillation (AF) among women over 65 who have no baseline AF. The purpose of the STAR study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. In a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ECG monitoring technology (iRhythm's ZIO® XT Patch). This subgroup of WHISH study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Physical ActivityThe Physical Activity Intervention Group will receive guidance on being physically active, including aerobics, flexibility, balance, strength, and decreased sedentary time. The primary resource is the National Institute of Aging Go4Life exercise and physical activity materials. The materials are based on the United States national guidelines for physical activity for older adults. Participants will wear the Zio patch monitor (electrocardiographic loop monitoring device) for 8 days at baseline, as well as at 6 months and again at one year, for a total of 3 times. |
| Usual Activity Control | No intervention | –Participants will wear the Zio patch monitor (electrocardiographic loop monitoring device) for 8 days at baseline, as well as at 6 months and again at one year, for a total of 3 times. Participants carry about their normal activities during this period. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Subjects already enrolled in the parent WHISH study.
- Subjects who are at high risk of developing atrial fibrillation.
Key exclusion criteria (1 listed)
- Subjects who have had atrial fibrillation at baseline.
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 |
|---|---|---|
| Physical ActivityThe PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available. | Behavioural | Physical Activity Intervention |
Primary outcome
Change in Incidence of Atrial Fibrillation Due to Exercise
Time frame: One year
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring
Time frame: One year
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 May 2022.
- Derived from this study: PubMed 42107553Gomez SE, Larson J, Hlatky MA, Kooperberg C, LaMonte M, Tinker L, Greenland P, Albert C, Froelicher V, Wheeler M, Stefanick ML, Perez MV. Women's health initiative strong and healthy silent atrial fibrillation recording study: Rationale, study design, and baseline data. Am Heart J. 2026 Oct;300:107478. doi: 10.1016/j.ahj.2026.107478. Epub 2026 May 8.
- Derived from this study: PubMed 36543503Lin JY, Larson J, Schoenberg J, Sepulveda A, Tinker L, Wheeler M, Albert C, Manson JE, Wells G, Martin LW, Froelicher V, LaMonte M, Kooperberg C, Hlatky MA, Greenland P, Stefanick ML, Perez MV. Serial 7-Day Electrocardiogram Patch Screening for AF in High-Risk Older Women by the CHARGE-AF Score. JACC Clin Electrophysiol. 2022 Dec;8(12):1523-1534. doi: 10.1016/j.jacep.2022.08.024. Epub 2022 Oct 26.
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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.
Marco Perez, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Atrial Fibrillation, run by Stanford University 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 2 inclusion and 1 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 May 2022. 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?
Change in Incidence of Atrial Fibrillation Due to Exercise (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366803, which also lists 2 linked publications.
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 May 2022.