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E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function
This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.
PRIMARY OBJECTIVES: I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors. II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. ARM 2: Patients receive educational materials at baseline. After completion of study intervention, patients are followed up at 3 months.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
August 28, 2023
Primary Completion Date
October 31, 2024
Completion Date
June 5, 2025
Last Updated
January 2, 2026
75
ACTUAL participants
Exercise Intervention
OTHER
Informational Intervention
OTHER
Nutritional Assessment
OTHER
Physical Performance Testing
OTHER
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
NCT05372640
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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