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Ohio State UniversityEvaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial
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Die klinische Studie NCT06445192 ist eine interventionsstudie zur Untersuchung von Lungenkarzinom und hat den Status offene rekrutierung. Die Studie startete am 3. November 2023 und soll 88 Teilnehmer aufnehmen. Durchgeführt von Ohio State University ist der Abschluss für 31. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. Juni 2025 aktualisiert.
Kurzbeschreibung
This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.
Ausführliche Beschreibung
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).
II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
GROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
After completion of study intervention, participants are followed up at 12 weeks and 1 year.
Offizieller Titel
The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
Erkrankungen
LungenkarzinomWeitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2023-11-03
Zuletzt aktualisiert
2025-06-03
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
88
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellGroup I (exercise intervention) Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth BIW in weeks 1-8 and QW in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up. | Biospezimen-Sammlung Undergo collection of blood samples Bewegungsberatung Attend group counseling Bewegungsintervention Receive aerobic and resistance exercise intervention via telehealth Verwendung und Bewertung von Medizinprodukten Wear Fitbit Test der körperlichen Leistungsfähigkeit Ancillary studies Fragebogenverwaltung Ancillary studies Telemedizin Receive aerobic and resistance exercise intervention via telehealth |
Aktives VergleichspräparatGroup II (usual care) Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up. | Best Practice Receive usual care Biospezimen-Sammlung Undergo collection of blood samples Verwendung und Bewertung von Medizinprodukten Wear Fitbit Test der körperlichen Leistungsfähigkeit Ancillary studies Fragebogenverwaltung Ancillary studies |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Number of patients recruited to virtually-delivered exercise intervention (feasibility) | To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC) | Up to 1 year |
Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted. | Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance. | During 12-week program |
Assess the number of participants with a change in inflammatory biomarkers | Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group. | Baseline to post-intervention (12 weeks) |
Microbe relative abundances | Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes. | Baseline to post-intervention (12 weeks) |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
40 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- 50-77 years of age
- Current or former smoker with 20-pack year smoking history and within the last 15 years
- Fewer than 150 minutes of participation in moderate intensity physical activity each week
- All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease [COPD]), or systemic disease that would make moderate intensity exercise participation unsafe
- Willing to sign an informed consent
- Person undergoing treatment for cancer in any form
- Person plans to enter smoking cessation or change status
Ohio State University455 aktive klinische Studien zum ErkundenVerantwortliche Partei
Marisa Bittoni, Hauptprüfer, Principal Investigator, Ohio State University Comprehensive Cancer Center
Zentrale Studienkontakte
Kontakt: The Ohio State Comprehensive Cancer Center, 800-293-5066, [email protected]
1 Studienstandorte in 1 Ländern
Ohio
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Marisa Bittoni, PhD, Kontakt, 614-206-3518, [email protected]
Marisa Bittoni, PhD, Hauptprüfer
Offene Rekrutierung