REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Pilot Study of Assisted Exercise in Obese Endometrial Cancer Patients
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 4 weeks post-EOT in obese EC patients who will be randomized to
perform 'assisted', voluntary or no exercise (healthy living educational information only).
Secondary Objective:
To objectively examine food behavior as determined by neuronal response to high- versus
low-calorie visual stimuli under fasted (hunger) and fed (satiated) 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 4 weeks
post-intervention (EOT+4) in obese EC patients performing 'assisted', voluntary or no
exercise (healthy living educational information only).
Patients will be randomized to receive either the assisted exercise (n=10), voluntary
exercise (n=10) or no exercise (n=6) 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. Patients in
the No Exercise/Educational Information Only control group will complete the same set of
questionnaires as the patients in the exercise groups.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Weight change from pre- to post-intervention
24 weeks after exercise intervention (EOT)
No
Nora Nock, PhD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Institutional Review Board
CASE5811
NCT01870947
September 2011
Name | Location |
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |