Women's Health Initiative Silent Atrial Fibrillation Recording Study

NCT05366803 | Completed

• 1 other identifier: 40082
• Study Type: interventional
• Target: 1,257
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Change in Incidence of Atrial Fibrillation Due to Exercise

  One year

• Number of Participants without Clinically Diagnosed Atrial Fibrillation (AF) Found to have Silent AF with Prolonged ECG Patch Monitoring

  One year

Study Arms (2)

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.

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.

Interventions

Physical Activity BEHAVIORAL

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.

Physical Activity Intervention

Eligibility Criteria

• Age: 65 Years - 100 Years
• Gender Eligibility Details: The participants are all older women, since the parent study is a post-menopausal study from the Women's Health Initiative.
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who have had atrial fibrillation at baseline.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Lin 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.

  PMID: 36543503 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marco Perez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Cardiovascular Medicine)

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: September 8, 2017
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)