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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
48
A 10-week home-based exercise intervention including weekly video conferences with exercise specialists.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Feasibility - Recruitment
Number of participants excluded or not agreeing to participate will be measured
Time frame: Baseline
Feasibility - Adherence to study protocol activities
Feasibility measure (e.g. percent of assessments and intervention sessions completed
Time frame: Throughout 10 week study period
Feasibility - Attrition rates
Feasibility measure of the number of participants who dropout or are withdrawn
Time frame: Throughout 10 week study period
Feasibility - Adverse events
Feasibility measure of the number of adverse events recorded by staff during the study period
Time frame: Throughout 10 week study period
Feasibility - Participant satisfaction
Self-Administered survey given to the participant at the conclusion of the 10 week study period
Time frame: At conclusion of 10 week study period
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Time frame: Baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Time frame: 5 weeks after baseline
Accelerometer Measured Free-living physical activity (e.g., minutes of activity)
Motion sensor measures physical activity not observed during intervention activities
Time frame: 10 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Time frame: Baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Time frame: 5 weeks after baseline
Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale
Measurement of body fat percentage (0-100%) where a lower percentage is better.
Time frame: 10 weeks after baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Time frame: Baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Time frame: 5 weeks after baseline
Muscle mass analysis using a Tanita bioelectrical impedance analysis scale
Measurement of muscle mass (0 - max body weight in kilograms) where having more muscle mass can be considered positive.
Time frame: 10 weeks after baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Time frame: Baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Time frame: 5 weeks after baseline
Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale
Measurement of height (m) and weight (kg) to assess body mass index, where a higher body mass index is worse.
Time frame: 10 weeks after baseline
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Time frame: Baseline
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Time frame: 5 weeks after baseline
Change in physical performance
Participants will complete a 2-minute step test measured by study staff through videoconference
Time frame: 10 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Time frame: Baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Time frame: 5 weeks after baseline
Composition of gut microbiota as measured by fecal samples
Using standard diversity and taxa comparison metrics
Time frame: 10 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Time frame: Baseline
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Time frame: 5 weeks after baseline
Fatigue measured through fatigue specific questionnaire
Fatigue Symptom Inventory which contains 13 items (fatigue intensity = mean of 4 items, 1 to 10 scale; fatigue interference = mean of 7 items, 0 to 10 scale; 2 general fatigue items = 0 to 7 scale and 1 to 10 scale); higher score indicates greater fatigue
Time frame: 10 weeks after baseline
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale \[HADS\] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Time frame: Baseline
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale \[HADS\] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Time frame: 5 weeks after baseline
Depression and Anxiety measured through specific questionnaire
Hospital Anxiety and Depression Scale \[HADS\] which contains 14 items (depression = total of 7 items, 0 to 3 scale; anxiety = total of 7 items, 0 to 3 scale) higher scores indicate greater depression and/or anxiety
Time frame: 10 weeks after baseline
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Time frame: Baseline
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Time frame: 5 weeks after baseline
Sleep dysfunction measured through specific questionnaire
Pittsburgh Sleep Quality Index which contains 7 components (sleep dysfunction = total of 7 components, 0 to 3 scale) higher score indicates worse sleep quality
Time frame: 10 weeks after baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Time frame: Baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Time frame: 5 weeks after baseline
Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®]
PROMIS® is a set of person-centered measures that evaluates and monitors physical health in adults (T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population) a higher score (higher SD) indicates greater pain
Time frame: 10 weeks after baseline
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Time frame: Baseline
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Time frame: 5 weeks after baseline
Post-traumatic stress measured through specific questionnaire
Post-traumatic Stress Disorder Checklist (PCL) which contains 20 items (PTSD intensity = total of 20 items, 0 to 4 scale) higher score indicates greater PTSD
Time frame: 10 weeks after baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.