Remote Exercise Program for Rural Men

Evaluating a Remotely Delivered Physical Activity Program for Inactive Men in Rural Communities: A Feasibility Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rural Health
• Intervention / Treatment: Behavioral: Remote Physical Activity Program (12 weeks); Behavioral: Delayed Remote Physical Activity Program (6 weeks)

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate; Receive intervention immediately after randomization	Behavioral: Remote Physical Activity Program (12 weeks); Participants will receive a 12 week remotely delivered physical activity program immediately after randomization. Participants will receive bi-weekly calls, behavioral lessons, and bi-weekly behavioral feedback via email.
Other: Delayed; Start intervention after 12 week assessment	Behavioral: Delayed Remote Physical Activity Program (6 weeks); Participants receive a 6 week remote physical activity program after completing the 12 week assessment. The program includes weekly calls, behavioral lessons, and weekly behavioral feedback via email.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Investigators: Study Director: Christine A Pellegrini, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Actual): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; behavioral intervention; Rural men
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: STUDY00000136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared on request to the PI
• IPD Sharing Time Frame: IPD will be available on request after outcomes have been published
• IPD Sharing Access Criteria: IPD will be available on request after outcomes have been published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No