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Low accrual
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| Name | Class |
|---|---|
| Colorado Clinical & Translational Sciences Institute | OTHER |
| National Cancer Institute (NCI) | NIH |
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The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined aerobic and resistance exercise | Experimental | 12 weeks of supervised resistance exercise and unsupervised aerobic exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined aerobic and resistance exercise | Behavioral | The 12-week intervention will build upon an ongoing resistance exercise program for cancer patients and survivors at the University of Colorado's Anschutz Health and Wellness Center. Resistance exercise will be led by certified cancer exercise specialists who provide individualized exercise programs to cancer patients and survivors. Exercise sessions are progressive, target all major muscle groups, are 50 minutes in duration, and completed 2x/week. The intervention will also include 3 self-directed moderate-intensity aerobic exercise sessions/week, building to 50 minutes at 60% heart rate maximum (determined at baseline). Target exercise will be achieved by a gradual progression of exercise duration over the first four weeks of the program. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and enrollment feasibility | Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study | Through study completion, up to two years |
| Subjective exercise adherence | Participants will be asked to rate on a 1-10 Likert scale: 1) how adherent they were to the prescribed exercise over the past week, 2) how difficult it was to adhere to the prescribed exercise over the past week, and 3) how likely they feel they can adhere to the prescribed exercise for the next month. | Changes across weeks 4, 8, and 12 |
| Exercise self efficacy | Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy | Changes across weeks 4, 8, and 12 |
| Exercise enjoyment | Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment | Changes across weeks 4, 8, and 12 |
| Intervention acceptability | Subjective ability to adhere to combined AEx/REx | 12 weeks |
| Intervention acceptability | Barriers to completing AEx/REx | 12 weeks |
| Intervention acceptability | Open-ended opinions on the structure and content of the exercise training sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ghrelin | Fasting ghrelin, ghrelin area under the curve in response to a control meal | Baseline, 12 weeks |
| Changes in peptide-YY (PYY) | Fasting PYY, PYY area under the curve in response to a control meal |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in resting energy expenditure | Resting energy expenditure measured by metabolic cart and adjusted for body composition changes | Baseline, 12 weeks |
| Changes in body composition | Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Cancer Center |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Masking is not possible because this is a single-arm exercise study.
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| 12 weeks |
| Intervention acceptability | Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention | 12 weeks |
| Objective exercise adherence | Adherence to additional study-specific AEx will be tracked through heart rate monitor data, logs of attendance, and participant diaries and compared to the REx-only intervention | 12 weeks |
| Baseline, 12 weeks |
| Changes in subjective appetite ratings | Changes in hunger, satiety, and prospective food consumption via visual analog scales | Baseline, 12 weeks |
| Changes in ad libitum energy intake | Energy intake from buffet-style meal | Baseline, 12 weeks |
| Changes in physical activity | Step count measured by accelerometers | Baseline, 12 weeks |
| Changes in sedentary behavior | Time in sedentary activities measured by accelerometers | Baseline, 12 weeks |
| Baseline, 12 weeks |
| Changes in fatigue | Measured by the Functional Assessment of Chronic Illness and Therapy - Fatigue; 13 questions; score range: 0-52, with higher score indicating higher fatigue | Baseline, 12 weeks |
| Denver |
| Colorado |
| 80238 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |