Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445192
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-10-17
Brief Title:
Evaluating 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
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
The BE FIT Study Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-05556 | REGISTRY | CTRP Clinical Trial Reporting Program | None |