Rural HealthNCT07224217
Remote Exercise Program for Rural Men
A study testing Remote Physical Activity Program (12 weeks) and Delayed Remote Physical Activity Program (6 weeks) in people with Rural Health, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rural Health
- What is being tested?
- Remote Physical Activity Program (12 weeks) and Delayed Remote Physical Activity Program (6 weeks)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Conditions
- Rural Health
- Being tested
- Remote Physical Activity Program (12 weeks), Delayed Remote Physical Activity Program (6 weeks)
- Keywords
- physical activity, behavioral intervention, Rural men
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Physical Activity Program (12 weeks)Behavioural
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.
Delayed Remote Physical Activity Program (6 weeks)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | Receive intervention immediately after randomization Receives: Behavioral: Remote Physical Activity Program (12 weeks) |
| Delayed | Other | Start intervention after 12 week assessment Receives: Behavioral: Delayed Remote Physical Activity Program (6 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Percentage of recruitment rate (screened/enrolled)
Measured: 12 weeks
Retention
Percentage of participants who complete the study
Measured: 12 weeks
Adherence to coaching calls
Percentage of coaching calls completed in Immediate condition
Measured: 12 weeks
Adherence to self-monitoring
Percentage of self-monitoring logs submitted in Immediate condition
Measured: 12 weeks
Acceptability
Program satisfaction with the 12 week remote program in Immediate condition
Measured: 12 weeks
Secondary outcomes (3)
Physical activity - Moderate to vigorous minutes/week
Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL
Measured: baseline to 12 weeks
Physical activity - Steps
Steps/day assessed by activPAL
Measured: baseline to 12 weeks
Global Health
Global Health assessed via PROMIS (t-score)
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start1 Nov 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rural HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine A Pellegrini, PhD, University of South Carolina
- Investigators
- Christine A Pellegrini, PhD, Study director, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224217
- Sponsor's protocol ID
- STUDY00000136
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared on request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Remotely Delivered Physical Activity Program for Inactive Men in Rural Communities: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07224217
- Acronym / sponsor ID
- STUDY00000136
- Conditions
- Rural Health
- Keywords
- physical activity, behavioral intervention, Rural men
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Behavioral: Remote Physical Activity Program (12 weeks)Receive intervention immediately after randomization |
| Delayed | Other | Behavioral: Delayed Remote Physical Activity Program (6 weeks)Start intervention after 12 week assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate |
| 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. | Behavioural | Delayed |
Primary outcome
Feasibility of recruitment
Time frame: 12 weeks
Percentage of recruitment rate (screened/enrolled)
Retention
Time frame: 12 weeks
Percentage of participants who complete the study
Adherence to coaching calls
Time frame: 12 weeks
Percentage of coaching calls completed in Immediate condition
Adherence to self-monitoring
Time frame: 12 weeks
Percentage of self-monitoring logs submitted in Immediate condition
Acceptability
Time frame: 12 weeks
Program satisfaction with the 12 week remote program in Immediate condition
3 secondary outcomes
Physical activity - Moderate to vigorous minutes/week
Time frame: baseline to 12 weeks
Physical activity - Steps
Time frame: baseline to 12 weeks
Global Health
Time frame: baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared on request to the PI
Related trials for Rural Health
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Recruiting
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Methamphetamine Use, Heart Failure
Not yet recruiting
Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans
Dementia, Cancer
Not yet recruitingObservational study
Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness
Severe Mental Illness, Hospitalizations Psychiatric
Recruiting
Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Students
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine A Pellegrini, PhD study director
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Physical Activity Program (12 weeks) and Delayed Remote Physical Activity Program (6 weeks) in people with Rural Health, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.