Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

Wake Forest University (WFU)

Status: Completed

Conditions: Leukemia

Treatments: Behavioral: exercise intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00554489

CDR0000573938

CCCWFU-98107

IRB00003355

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 50 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)