Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554489
• Other study ID #: CDR0000573938
• Secondary ID: CCCWFU-98107IRB0
• Status: Completed
• Phase: N/A
• First received: November 6, 2007
• Last updated: August 14, 2017
• Start date: July 2007
• Est. completion date: April 2011

Study information

• Verified date: August 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• exercise intervention
participation in physical activity intervention program weeks 2 through 5

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		day 1
Primary	Percentage of eligible patients recruited into the study		day 1
Primary	Number and frequency of reported barriers to eligibility and enrollment		day 1
Primary	Percentage of study participants who successfully completed the physical and the psychosocial measures		week 13
Primary	Record barriers to completion of the physical activity program		week 13
Secondary	Physical function as measured by the Short Physical Performance Battery (SPPB)		week 13
Secondary	Quality of Life as measured with the Distress Thermometer		week 13