Clinical Trials Directory

Trials / Completed

CompletedNCT05000502

Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Although scientific studies support a link between exercise and the gut microbiome, rigorous randomized trials needed to confirm this causal link are limited and usually involve supervised exercise. Hence, this proposal tests feasibility of a home-based, remote-only research protocol that is more accessible to cancer survivors unable to attend supervised exercise including but not limited to rural populations. This study will also determine if exercise effects on the gut microbiome differ by factors such as race.

Detailed description

Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will be asked to maintain their pre-study diet and attempt to maintain their body weight while participating in the study. Assessments will occur at baseline, week 5 (mid-intervention), and week 10 (post-intervention) by videoconference platform. Study feasibility and changes in the gut microbiome will be assessed.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHome-based exercise interventionA 10-week home-based exercise intervention including weekly video conferences with exercise specialists.

Timeline

Start date
2021-09-01
Primary completion
2024-01-22
Completion
2024-01-31
First posted
2021-08-11
Last updated
2024-03-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05000502. Inclusion in this directory is not an endorsement.