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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA235598 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.
Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise Training | Experimental | Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors. |
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| Attention Control | Active Comparator | The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise Training | Other | Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Composition of gut microbiota as measured by fecal samples | Using standard diversity and taxa comparison metrics | Baseline |
| Composition of gut microbiota as measured by fecal samples | Using standard diversity and taxa comparison metrics | 5 weeks after baseline |
| Composition of gut microbiota as measured by fecal samples | Using standard diversity and taxa comparison metrics | 10 weeks after baseline |
| Composition of gut microbiota as measured by fecal samples | Using standard diversity and taxa comparison metrics | 15 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic inflammation tested via blood biomarkers | Blood samples will be analyzed for markers of inflammation (IL-6, IL-10) | Baseline |
| Systemic inflammation tested via blood biomarkers | Blood samples will be analyzed for markers of inflammation (IL-6, IL-10) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol | Cardiorespiratory fitness test on a treadmill | Baseline |
| Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol |
Inclusion criteria:
Exclusion criteria:
self-representation
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| Name | Affiliation | Role |
|---|---|---|
| Laura Q Rogers, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38702085 | Derived | Little RB, Carter SJ, Motl RW, Hunter G, Cook A, Liu N, Krontiras H, Lefkowitz EJ, Turan B, Schleicher E, Rogers LQ. Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial. BMJ Open. 2024 May 3;14(5):e081660. doi: 10.1136/bmjopen-2023-081660. |
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Any data collected with National Institutes of Health (NIH) funding and made public through publication in a peer-reviewed format will thereafter be available on request to faculty of institutions with Public Health Service (PHS) assurance. For sharing data and specimens from individual human subjects, the investigators will comply with all relevant policies including the "Standards for Privacy of Individually Identifiable Health Information" rule of the Health Insurance Portability and Accountability Act (HIPAA). For sharing data, the investigators will comply with the requirements of the Final NIH Statement on Sharing Research Data (NOT-OD-03-032), the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) (NOT-OD-07-088), the NIH Genomic Data Sharing Policy (NOT-OD-14-124), and all other existing, updated, and new requirements as stated by NIH policy.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Randomized controlled trial
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Assessors will be blinded to participant study group allocation
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| Attention Control | Other | The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance. |
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| 5 weeks after baseline |
| Systemic inflammation tested via biomarkers | Blood samples will be analyzed for markers of inflammation (IL-6, IL-10) | 10 weeks after baseline |
| Systemic inflammation tested via blood biomarkers | Blood samples will be analyzed for markers of inflammation (IL-6, IL-10) | 15 weeks after baseline |
| Autonomic nervous system measured through non-invasive ECG | Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly | Baseline |
| Autonomic nervous system measured through non-invasive ECG | Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly | 5 weeks after baseline |
| Autonomic nervous system measured through non-invasive ECG | Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly | 10 weeks after baseline |
| Autonomic nervous system measured through non-invasive ECG | Using a Actiheart 5 to measure heart rate variability and impedance cardiography while resting quietly | 15 weeks after baseline |
| Concentration of cortisol measured through hair sample | Hormone change that is associated with stress | Baseline |
| Concentration of cortisol measured through hair sample | Hormone change that is associated with stress | 5 weeks after baseline |
| Concentration of cortisol measured through hair sample | Hormone change that is associated with stress | 10 weeks after baseline |
| Concentration of cortisol measured through hair sample | Hormone change that is associated with stress | 15 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 | 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 | 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 | 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 | 15 weeks after baseline |
Cardiorespiratory fitness test on a treadmill
| 5 weeks after baseline |
| Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol | Cardiorespiratory fitness test on a treadmill | 10 weeks after baseline |
| Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol | Cardiorespiratory fitness test on a treadmill | 15 weeks after baseline |
| Walking Economy measured via 6 minute treadmill test | Fitness test on a treadmill | Baseline |
| Walking Economy measured via 6 minute treadmill test | Fitness test on a treadmill | 5 weeks after baseline |
| Walking Economy measured via 6 minute treadmill test | Fitness test on a treadmill | 10 weeks after baseline |
| Walking Economy measured via 6 minute treadmill test | Fitness test on a treadmill | 15 weeks after baseline |
| Accelerometer Measured Free-living physical activity (e.g., minutes of activity) | Motion sensor measures physical activity not observed during intervention activities | Baseline |
| Accelerometer Measured Free-living physical activity (e.g., minutes of activity) | Motion sensor measures physical activity not observed during intervention activities | 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 | 10 weeks after baseline |
| Accelerometer Measured Free-living physical activity (e.g., minutes of activity) | Motion sensor measures physical activity not observed during intervention activities | 15 weeks after baseline |
| Body composition using a dual energy x-ray absorptiometry | Measurement of body composition | Baseline |
| Body composition using a dual energy x-ray absorptiometry | Measurement of body composition | 5 weeks after baseline |
| Body composition using a dual energy x-ray absorptiometry | Measurement of body composition | 10 weeks after baseline |
| Body composition using a dual energy x-ray absorptiometry | Measurement of body composition | 15 weeks after baseline |
| FACT-B self-administered survey measuring quality of life | Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life | Baseline |
| FACT-B self-administered survey measuring quality of life | Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life | 5 weeks after baseline |
| FACT-B self-administered survey measuring quality of life | Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life | 10 weeks after baseline |
| FACT-B self-administered survey measuring quality of life | Functional Assessment of Cancer Therapy (FACT) - Breast quality of life scale (37 items; 0 to 4 scale; range is 0 to 148); higher score indicates better quality of life | 15 weeks after baseline |
| Self-efficacy by self-administered survey | Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy. | Baseline |
| Self-efficacy by self-administered survey | Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy. | 6 weeks after baseline |
| Self-efficacy by self-administered survey | Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy. | 10 weeks after baseline |
| Self-efficacy by self-administered survey | Self-efficacy measured with 15 items (barriers self-efficacy = 9 items and walking self-efficacy = 6 items, mean of 0% to 100% Scale, range is 0% to 100%); higher score indicates higher self-efficacy. | 15 weeks after baseline |
| Self-administered survey measuring mood and stress | Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress. | Baseline |
| Self-administered survey measuring mood and stress | Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress. | 5 weeks after baseline |
| Self-administered survey measuring mood and stress | Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress. | 10 weeks after baseline |
| Self-administered survey measuring mood and stress | Measurement of mood and stress after a traumatic experience, Civilian PTSD ( total of 17 items, 1 to 5 scale; range of 17 to 85) higher scores indicate greater PTSD. Perceived Stress Scale - 10 (10 items, 1 to 5 scale; 10 to 50 range) higher score indicates greater perceived stress. | 15 weeks after baseline |
| Self-administered survey measuring memory | Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory. | Baseline |
| Self-administered survey measuring memory | Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory. | 5 weeks after baseline |
| Self-administered survey measuring memory | Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory. | 10 weeks after baseline |
| Self-administered survey measuring memory | Measurement of memory through frequency of forgetting scale (total of 10 items, 1 to 7 scale; range of 10 to 70) higher score indicate lower frequency of forgetting and higher level of memory. | 15 weeks after baseline |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |