An interventional study of Combined aerobic and resistance exercise in Breast Cancer Female and Overweight and Obesity, sponsored by University of Colorado, Denver. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other
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).
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 3 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
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Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
12 weeks of supervised resistance exercise and unsupervised aerobic exercise.
Behavioral: Combined aerobic and resistance exercise
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.
Recruitment and enrollment feasibility
Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Changes across weeks 4, 8, and 12
Intervention acceptability
Subjective ability to adhere to combined AEx/REx
Time frame: 12 weeks
Intervention acceptability
Barriers to completing AEx/REx
Time frame: 12 weeks
Intervention acceptability
Open-ended opinions on the structure and content of the exercise training sessions
Time frame: 12 weeks
Intervention acceptability
Changes in subjective physical function, cancer-specific side effects, and overall well-being directly related to the exercise intervention
Time frame: 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
Time frame: 12 weeks
Changes in ghrelin
Fasting ghrelin, ghrelin area under the curve in response to a control meal
Time frame: Baseline, 12 weeks
Changes in peptide-YY (PYY)
Fasting PYY, PYY area under the curve in response to a control meal
Time frame: Baseline, 12 weeks
Changes in subjective appetite ratings
Changes in hunger, satiety, and prospective food consumption via visual analog scales
Time frame: Baseline, 12 weeks
Changes in ad libitum energy intake
Energy intake from buffet-style meal
Time frame: Baseline, 12 weeks
Changes in physical activity
Step count measured by accelerometers
Time frame: Baseline, 12 weeks
Changes in sedentary behavior
Time in sedentary activities measured by accelerometers
Time frame: Baseline, 12 weeks
Changes in resting energy expenditure
Resting energy expenditure measured by metabolic cart and adjusted for body composition changes
Time frame: Baseline, 12 weeks
Changes in body composition
Fat mass and fat-free mass in kg, measured by dual X-ray absorptiometry
Time frame: 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
Time frame: Baseline, 12 weeks
Plan to share: No
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This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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