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A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia

50 Years
Not Enrolling

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Trial Information

A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia



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


- 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

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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

day 1

Safety Issue:


Principal Investigator

Suzanne C. Danhauer, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

April 2011

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096