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Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.
PRIMARY OBJECTIVES: I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML. II. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery). SECONDARY OBJECTIVES: I. To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly. ARM II: Patients undergo usual care for 4 weeks. After completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24.
Age
60 - No limit years
Sex
ALL
Healthy Volunteers
No
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Start Date
October 1, 2012
Primary Completion Date
March 5, 2015
Completion Date
February 5, 2017
Last Updated
August 16, 2019
70
ESTIMATED participants
quality-of-life assessment
PROCEDURE
counseling intervention
OTHER
exercise intervention
BEHAVIORAL
educational intervention
OTHER
standard follow-up care
PROCEDURE
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT02159495
NCT02122081
Data Source & Attribution
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