Remote Exercise Program for Rural Men

Not Applicable

Recruiting

• Conditions: Rural Health

• Registration Number: NCT07224217
• Lead Sponsor: University of South Carolina

Brief Summary

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a remote physical activity intervention designed for rural inactive men.

Detailed Description

The proposed study is a pilot randomized controlled trial that will randomize participants to either 1) Immediate intervention, which consists of a 12-week physical activity program or 2) Delayed Intervention, which participants will be assigned to a 6-week abridged version of the program at the end of 12 weeks. Both versions of the physical activity program will provide participants a platform to report their exercise weekly, behavioral lessons, and receive personalized feedback on activity levels. The primary endpoint is to examine the feasibility and acceptability of the 12-week program by evaluating recruitment and retention rates, completion of phone calls, adherence to physical activity self-monitoring, and program satisfaction at 12-weeks. Preliminary efficacy will be assessed by changes in moderate-vigorous physical activity (MVPA), steps/day, health-related quality of life, self-efficacy, self-regulation, and supportive accountability at the end of 12-weeks.

Study Timeline

• Study First Submitted: 2025-10-31
• Study First Submitted QC: 2025-10-31
• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Posted: 2025-11-04
• Last Update Submitted: 2025-11-14
• Last Update Posted: 2025-11-17
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Identify biological sex as male
• Engage in less than 90 minutes of self-reported moderate intensity exercise
• Ability to read and write in English
• Primarily living in a rural jurisdiction defined by 1 of the 7 more widely used definitions of rurality by the United States government
• Ability to walk independently for at least one block

Exclusion Criteria

• Have a medical condition that could be made worse with a change in physical activity
• Plans to relocate from primary residence within 3 months of signing up for study
• Not willing to wear physical activity monitor for 7 days or complete surveys
• Less than 4 valid days of activity monitor wear time at baseline assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability	12 weeks	Program satisfaction with the 12 week remote program in Immediate condition
Adherence to self-monitoring	12 weeks	Percentage of self-monitoring logs submitted in Immediate condition
Feasibility of recruitment	12 weeks	Percentage of recruitment rate (screened/enrolled)
Retention	12 weeks	Percentage of participants who complete the study
Adherence to coaching calls	12 weeks	Percentage of coaching calls completed in Immediate condition

Secondary Outcome Measures

Name	Time	Method
Physical activity - Moderate to vigorous minutes/week	baseline to 12 weeks	Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL
Physical activity - Steps	baseline to 12 weeks	Steps/day assessed by activPAL
Global Health	baseline to 12 weeks	Global Health assessed via PROMIS (t-score)

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States