Brief Title
Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
Official Title
Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Feasibility, in terms of participation rates and barriers to recruitment and retention
Secondary Outcome
Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
Condition
Adult Acute Myeloid Leukemia in Remission
Intervention
quality-of-life assessment
Study Arms / Comparison Groups
Arm I (physical activity)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
70
Start Date
October 2012
Completion Date
February 5, 2017
Primary Completion Date
March 5, 2015
Eligibility Criteria
Inclusion Criteria: - Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria - Planned induction chemotherapy - Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain) - Patient must be ambulatory or able to walk with a cane - Patients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer Mental Status Scale) - Adequate English skills to understand and complete questionnaires - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability) - Inability to ambulate
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Heidi Klepin, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01519596
Organization ID
IRB00019467
Secondary IDs
NCI-2012-00003
Responsible Party
Sponsor
Study Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Heidi Klepin, Principal Investigator, Wake Forest University Health Sciences
Verification Date
August 2019