Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
|ClinicalTrials.gov Identifier: NCT00554489|
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : August 17, 2017
RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.
PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.
|Condition or disease||Intervention/treatment|
|Leukemia||Behavioral: exercise intervention|
- To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy.
- To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.
OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments.
Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 .
After completion of study intervention, patients are followed for 4 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia|
|Study Start Date :||July 2007|
|Primary Completion Date :||November 2008|
|Study Completion Date :||April 2011|
Behavioral: exercise intervention
- Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study [ Time Frame: day 1 ]
- Percentage of eligible patients recruited into the study [ Time Frame: day 1 ]
- Number and frequency of reported barriers to eligibility and enrollment [ Time Frame: day 1 ]
- Percentage of study participants who successfully completed the physical and the psychosocial measures [ Time Frame: week 13 ]
- Record barriers to completion of the physical activity program [ Time Frame: week 13 ]
- Physical function as measured by the Short Physical Performance Battery (SPPB) [ Time Frame: week 13 ]
- Quality of Life as measured with the Distress Thermometer [ Time Frame: week 13 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554489
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Suzanne C. Danhauer, PhD||Wake Forest University Health Sciences|
|Principal Investigator:||Heidi D. Klepin, MD||Wake Forest University Health Sciences|
|Principal Investigator:||Shannon Mihalko, PhD||Wake Forest University Health Sciences|