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Universität von South CarolinaRemote Exercise Program for Rural Men
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07224217 ist eine interventionsstudie zur Untersuchung von Ländliche Gesundheit und hat den Status offene rekrutierung. Die Studie startete am 1. November 2025 und soll 40 Teilnehmer aufnehmen. Durchgeführt von Universität von South Carolina ist der Abschluss für 30. April 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 17. November 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.
Offizieller Titel
Evaluating a Remotely Delivered Physical Activity Program for Inactive Men in Rural Communities: A Feasibility Study
Erkrankungen
Ländliche GesundheitWeitere Studien-IDs
- STUDY00000136
NCT-Nummer
Studienbeginn (tatsächlich)
2025-11-01
Zuletzt aktualisiert
2025-11-17
Studienende (vorauss.)
2026-04-30
Geplante Rekrutierung
40
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
physical activity
behavioral intervention
Rural men
behavioral intervention
Rural men
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellImmediate Receive intervention immediately after randomization | 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. |
AndereDelayed Start intervention after 12 week assessment | 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Männlich
Akzeptiert gesunde Freiwillige
Ja
- 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
- 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
Universität von South Carolina303 aktive klinische Studien zum ErkundenVerantwortliche Partei
Christine A Pellegrini, PhD, Hauptprüfer, Associate Professor, University of South Carolina
Zentrale Studienkontakte
Kontakt: Scott Jamieson, 803-777-9236, [email protected]
Kontakt: Christine Pellegrini, PhD, 803-777-0911, [email protected]
1 Studienstandorte in 1 Ländern
South Carolina
University of South Carolina, Columbia, South Carolina, 29208, United States
Scott Jamieson, Kontakt, 803-777-9236, [email protected]
Offene Rekrutierung