Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2020-02-07
2022-02-05
Brief Summary
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Detailed Description
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A randomized cross-over short-term study design was chosen to assessment to profile appetite, energy intake, and physical activity in controlled and free-living settings while also reducing participant burden (as opposed to a long-term intervention). Participants will serve as their own controls, thereby circumventing inter-individual variation in physiology that may confound results. It is anticipated that responses to acute exercise will be amplified in chronic interventions and may therefore be used as a basis for generating hypotheses on the regulation of certain energy balance components. The study will end after the completion of 3 days of dietary intake recall and physical activity measurement for the last participant.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Sedentary Control/REx
Subjects will complete the Sedentary control testing sessions, have a 7-14 day washout period, and then complete the REx
REx Condition First
REx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete \~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM.
Sedentary Control Condition First
Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.
REx/Sedentary Control
Subjects will complete the REx testing sessions, have a 7-14 day washout period, and then complete the Sedentary control
REx Condition First
REx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete \~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM.
Sedentary Control Condition First
Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.
Interventions
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REx Condition First
REx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete \~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM.
Sedentary Control Condition First
Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.
Eligibility Criteria
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Inclusion Criteria
* Age: 18 - 45 years, since older age may impact appetite regulation45-47 and women \>45 are more likely to have begun the menopausal transition (estrogen relates to appetite and eating behavior)
* Body mass index \[BMI\]: 25 - 35 kg/m2. Since body composition and body mass relate to appetite regulation and energy intake, a narrow BMI range should decrease heterogeneity within the results. The BMI range was chosen to represent a population at risk for developing obesity and associated comorbidities, while also excluding individuals with severe obesity (which may plausibly significantly impact energy intake regulation).
* Pre-menopausal before cancer diagnosis and treatment
* \<1 hour/week of planned physical activity by self-report in the previous 12 months, since exercise may alter appetite and response to food
* Diagnosis of primary stage I - II estrogen receptor/progesterone receptor-positive (ER/PR+) breast cancer, according to institutional standards.
* All chemotherapy, radiation, and surgery completed at least two weeks (14 days), but less than 6 months prior to registration
Exclusion Criteria
* History of cardiovascular disease or symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
* Diabetes mellitus, uncontrolled hypertension (defined as: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100mmHg, as measured during the screening visit with participants seated quietly), untreated/uncontrolled thyroid disease, or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition become controlled they will be allowed to be re-evaluated for inclusion in the current trial.
* Unable to exercise due to cardiac, pulmonary, neurological, orthopedic reasons.
* Currently smoking and/or nicotine use.
* Treatment with medications known to significantly affect appetite, weight, energy metabolism, EI or energy expenditure in the last 3 months (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
* Corticosteroid use within the last two weeks
* History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons
* Currently pregnant, lactating or less than 6 months post-partum.
* Score of ≥ 2 on the CAGE (cut-annoyed-guilty-eye opener) questionnaire adapted to include drug use
* Score of \> 20 on the Eating Attitude Test - 26 (EATS-26), indicative of disordered eating. Participants with a score \>20 on the EATS-26 will be referred to their primary care physician for further evaluation.
* Significant food intolerances/allergies that cannot be accommodated by the University of Colorado Hospital Clinical Translational Research Center (CTRC) Metabolic Kitchen.
* Currently participating in any formal weight loss or physical activity programs or clinical trials for weight loss.
* Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician, Dr. Marc-Andre Cornier).
* Unable or unwilling to undergo study procedures
18 Years
45 Years
FEMALE
No
Sponsors
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Colorado Clinical & Translational Sciences Institute
OTHER
National Center for Advancing Translational Sciences (NCATS)
NIH
National Cancer Institute (NCI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Ed Melanson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Countries
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References
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Purcell SA, Melanson EL, Afghahi A, Borges VF, Sinelli I, Cornier MA. The effects of resistance exercise on appetite sensations, appetite related hormones and energy intake in hormone receptor-positive breast cancer survivors. Appetite. 2023 Mar 1;182:106426. doi: 10.1016/j.appet.2022.106426. Epub 2022 Dec 17.
Related Links
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Main results of the study
Other Identifiers
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19-1974.cc
Identifier Type: -
Identifier Source: org_study_id