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Women's Health Initiative Silent Atrial Fibrillation Recording Study

Women's Health Initiative Strong and Healthy Silent Atrial Fibrillation Recording Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05366803
Acronym
WHISH STAR
Enrollment
1257
Registered
2022-05-09
Start date
2017-09-08
Completion date
2020-02-11
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief 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. 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.

Interventions

BEHAVIORALPhysical Activity

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects already enrolled in the parent WHISH study. * Subjects who are at high risk of developing atrial fibrillation.

Exclusion criteria

* Subjects who have had atrial fibrillation at baseline.

Design outcomes

Primary

MeasureTime frame
Change in Incidence of Atrial Fibrillation Due to ExerciseOne year
Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch MonitoringOne year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026