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Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554489
First Posted: November 7, 2007
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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.


Condition Intervention
Leukemia Behavioral: exercise intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: July 2007
Study Completion Date: April 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: exercise intervention
    participation in physical activity intervention program weeks 2 through 5
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554489


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00554489     History of Changes
Other Study ID Numbers: CDR0000573938
CCCWFU-98107
IRB00003355
First Submitted: November 6, 2007
First Posted: November 7, 2007
Last Update Posted: August 17, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms