Clinical trial · Interventional
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
The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Exercise Counseling | Other | — | UNRESOLVED |
| Exercise Intervention | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Physical Performance Testing | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telemedicine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (exercise intervention)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Exercise Counseling
- Other: Exercise Intervention
- Other: Medical Device Usage and Evaluation
- Other: Physical Performance Testing
- Other: Questionnaire Administration
- Other: Telemedicine
- type
- ACTIVE_COMPARATOR
- label
- Group II (usual care)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Person undergoing treatment for cancer in any form * Person plans to enter smoking cessation or change status
References
Publications (0)
Data not yet available