Assisted Exercise in Obese Endometrial Cancer Patients
REWARD (Revving-Up Exercise for Sustained Weight Loss by Altering Neurological Reward and Drive): A Randomized Trial of Assisted Exercise in Obese Endometrial Cancer Patients
1 other identifier
interventional
95
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2011
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2019
CompletedJanuary 27, 2020
January 1, 2020
8 years
June 4, 2013
January 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight change from pre- to post-intervention
24 weeks after exercise intervention (EOT)
Secondary Outcomes (6)
Change in Body Composition from baseline
at 4 weeks after exercise intervention(EOT)
Change in Motivation to Exercise from baseline
24 weeks after exercise intervention (EOT)
Change in Eating Behavior from baseline
24 weeks after exercise intervention (EOT)
Change in Quality of Life (QoL)from baseline
24 weeks after exercise intervention (EOT)
Change in Depression from baseline
24 weeks after exercise intervention (EOT)
- +1 more secondary outcomes
Study Arms (2)
'Assisted-Rate' Exercise Intervention
EXPERIMENTALSubjects 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.
'Voluntary-Rate' Exercise Intervention
EXPERIMENTALSubjects 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.
Interventions
Informational brochure ("Better Health and You," Weight Control Information Network, June, 2004)
Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.
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).
Eligibility Criteria
You may qualify if:
- Histologically confirmed Stage I endometrial adenocarcinoma (EC), grade 1 or 2, with no adjuvant chemotherapy. Patients will be eligible to enroll as soon as 3 months after completion of treatment but no later than 4 years after completion of treatment.
- BMI ≥ 30.0 (obese)
- Approved to be contacted by the patient's treating gynecologic oncologist
- Meets screening criteria including successful completion of a cardiopulmonary stress test
- Receives medical clearance from the patient's primary care physician (PCP) or gynecologic oncologist to exercise in this study
You may not qualify if:
- Individuals unable to read and provide informed consent.
- Women currently participating in a structured weight loss or exercise program in the past 6 months or any woman who has previously had bariatric surgery or is planning to undergo bariatric surgery in the next 12 months
- Participants who do not consent to be in the study or who will be unavailable for follow-up assessments,
- Pre-existing medical conditions that would be a barrier for participation in supervised exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Related Publications (1)
Nock NL, Dimitropoulos A, Zanotti KM, Waggoner S, Nagel C, Golubic M, Michener CM, Kirwan JP, Alberts J. Sleep, quality of life, and depression in endometrial cancer survivors with obesity seeking weight loss. Support Care Cancer. 2020 May;28(5):2311-2319. doi: 10.1007/s00520-019-05051-1. Epub 2019 Sep 2.
PMID: 31478164DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nora Nock, PhD
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 6, 2013
Study Start
September 7, 2011
Primary Completion
September 4, 2019
Study Completion
September 4, 2019
Last Updated
January 27, 2020
Record last verified: 2020-01