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Winston-Salem, North Carolina 27157


Purpose:

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.


Study summary:

OBJECTIVES: Primary - To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy. Secondary - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia (AML) by WHO criteria - Planning to undergo induction or reinduction chemotherapy - Inpatient status at Wake Forest University Baptist Medical Center - Must not require intensive care unit support PATIENT CHARACTERISTICS: - Able to understand English - Medical eligibility confirmed with Leukemia Service Attending - Ambulatory or able to walk with a cane - No hemodynamic instability - No acute thrombosis within the past 7 days - No active ischemia within the past 7 days - No uncontrolled pain - Must have < 3 incorrect responses on the Pfeiffer Mental Status Exam PRIOR CONCURRENT THERAPY: - See Disease Characteristics


NCT ID:

NCT00554489


Primary Contact:

Study Chair
Suzanne C. Danhauer, PhD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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