Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Postmenopausal Clinical Trial

Official title:

A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590507
• Other study ID #: 22-007713
• Status: Completed
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: November 21, 2023

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients self-report as being > 1 year postmenopausal.

• Patients are able to walk without a walking aid.

• Patients own and know how to operate a smart phone or tablet.

• Patients are willing and able to complete the activity monitoring.

• Patients are self-reportedly underactive.

Exclusion Criteria:

• Patients are < 1 year postmenopausal.

• Patients require a walking aid for daily mobility.

• Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.

• Patients' primary form of exercise is swimming (the activity monitors are not waterproof).

• Patients are unable or unwilling to complete activity monitoring.

• Patients are unable to provide informed consent independently.

Related Conditions & MeSH terms

• Postmenopausal

Intervention

Behavioral:
• Mindfulness Audio Recordings
A 5-minute audio file aimed to increase likelihood of experiencing positive affect associated with physical activity. Participants will listen to a mindfulness audio file at the beginning of each physical activity session they choose to engage in during weeks 2-4

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of a mindfulness-based physical activity intervention	Number of subjects to rate the remotely-accessible and physical activity-targeted mindfulness audio file as acceptable	4 weeks
Secondary	Daily physical activity	Number of subjects to have an increase in objectively measured daily physical activity variables (such as step counts) recorded by ActiGraph activity monitor	4 weeks