An interventional study of Exercise on stationary recumbent exercise cycle and Health Education in Stage I Endometrial Adenocarcinoma, Uterine Cancer and Obesity, sponsored by Case Comprehensive Cancer Center. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
This is an assisted exercise trial involving exercise on a stationary bike, brain imaging and DNA(genetics)sampling. The purpose of this study is to find out if performing a progressive, supervised assisted exercise program on a stationary bike improves quality of life, increases motivation to continue to exercise, improves dietary behavior and leads to sustained weight loss in women who have had early-stage endometrial cancer. Questionnaires will be used to assess exercise motivation and dietary behavior. Brain's responses to different visual images will also be assessed.
Primary Objective:
To evaluate changes in body weight, fitness, bi-manual dexterity, exercise motivation and self-reported eating behavior (via questionnaires) before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-EOT, in obese EC patients who will be randomized to perform 'assisted' or voluntary exercise.
Secondary Objectives:
Objective 1: To objectively examine food behavior as determined by neuronal response to high- versus low-calorie visual stimuli under fasted (hunger) and fed (satiated) states and stop/go signaling (SST) in fed states in brain regions of interest (reward and motivation circuitry) using blood oxygenation level dependent (BOLD) functional MRI before and after a 16-week exercise intervention (EOT) and 12 and 24 weeks post-intervention in obese EC patients performing 'assisted' and voluntary exercise.
Objective 2: To examine the modification of the neuronal response to high vs. low calorie food images in regions of interest by polymorphisms in key genes (e.g., dopamine receptor and dopamine transporter) and serum biomarkers (e.g., leptin, BDNF) involved in regulating homeostatic and non-homeostatic energy systems.
Patients will be randomized to receive either the assisted exercise (n=60) or voluntary exercise (n=60) group. Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks. The control group will be asked to complete all exercise, body composition and fMRI testing similar to the exercise groups.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 95 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in the assisted exercise group will cycle on the same stationary exercise bike; however, a motor will provide assistance to the patient in order to maintain a pedaling rate 35% greater than their voluntary rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.
Behavioral: Exercise on stationary recumbent exercise cycle · Behavioral: Health Education · Behavioral: Questionnaires · Procedure: Neuroimaging · Procedure: Genetic and Biomarkers
Subjects in the voluntary group will exercise on a stationary recumbent exercise cycle and pedal at their preferred rate. Subjects in the exercise groups will complete 45 minute to 1-hour sessions, three times per week for eight weeks.
Behavioral: Exercise on stationary recumbent exercise cycle · Behavioral: Health Education · Behavioral: Questionnaires · Procedure: Neuroimaging · Procedure: Genetic and Biomarkers
Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)
Also known as: Exercise Motivations Inventory (EMI-2), Intrinsic Motivational Inventory (IMI), Three-Factor Eating Questionnaire (TFEQ), Functional Assessment of Cancer Therapy - General (FACT-G), FACT-En, Short-form Medical Outcomes (SF-36), Beck Depression Inventory (BDI), Godin Leisure-Time Exercise (LSI)
Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.
Also known as: MRI
Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).
Also known as: DNA Testing, Biomarker Testing
Weight change from pre- to post-intervention
Time frame: 24 weeks after exercise intervention (EOT)
Change in Body Composition from baseline
Body fat, lean mass and bone mass will be measured with a Lunar iDXA™ (GE Healthcare, Madison, WI. BMI will be computed (weight in kg divided by square of height in meters) and categorized as: \< 18.5 (underweight), 18.5 to 24.9 (normal weight), 25.0 to 29.9 (overweight)
Time frame: at 4 weeks after exercise intervention(EOT)
Change in Motivation to Exercise from baseline
Evaluate motivation to exercise using the Exercise Motivations Inventory (EMI-2) 122 and the Intrinsic Motivational Inventory (IMI) modified for exercise. Past physical activity habits will be assessed with the Godin Leisure-Time Exercise (LSI) questionnaire.
Time frame: 24 weeks after exercise intervention (EOT)
Change in Eating Behavior from baseline
Eating behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ). The TFEQ includes 51 items and addresses three dimensions of human eating behavior; restraint, disinhibition, and perceived hunger.
Time frame: 24 weeks after exercise intervention (EOT)
Change in Quality of Life (QoL)from baseline
The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item core questionnaire evaluating various domains of QoL including, physical, functional, family-social, and emotional well-being. The FACT-En is a 16-item subscale specific for endometrial cancer (EC) and assesses hormone withdrawal, pelvic symptoms, and possible adjuvant therapy side effects. Short-form Medical Outcomes (SF-36) consists of 36 questions scored on a Likert scale, producing overall physical and mental component summary measures.
Time frame: 24 weeks after exercise intervention (EOT)
Change in Depression from baseline
The Beck Depression Inventory (BDI) is a 21-item, Likert-scaled instrument of depressive symptoms that is well-validated and frequently used in lifestyle research studies. Each item is rated on a 4- point scale ranging from 0 to 3 (higher scores are associated with greater symptoms).
Time frame: 24 weeks after exercise intervention (EOT)
Exercise Session Adherence
Barriers to adhering to the exercise protocol will be assessed prospectively using an elicitation procedure similar to that suggested in the theory of planned behavior, whereby an open-ended question is asked to solicit the barrier without any preconceived notion of what the barrier might be. Specifically, participants in the exercise groups will be asked to book their weekly supervised exercise sessions with the Exercise Specialist/Physiologist. Participants cancelling an exercise session or requesting to be removed from the study will be asked why they are no longer interested in completed the program.
Time frame: 24 weeks after exercise intervention (EOT)
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Case Comprehensive Cancer Center