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Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519596
First Posted: January 27, 2012
Last Update Posted: June 1, 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
January 20, 2012
January 27, 2012
June 1, 2017
October 2012
December 2018   (Final data collection date for primary outcome measure)
  • Feasibility, in terms of participation rates and barriers to recruitment and retention [ Time Frame: Approximately 4 weeks ]
    Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.
  • Magnitude and trajectory of changes in objective physical function [ Time Frame: Approximately 4 weeks ]
    Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.
Same as current
Complete list of historical versions of study NCT01519596 on ClinicalTrials.gov Archive Site
  • Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength [ Time Frame: Approximately 4 weeks ]
  • Self-reported quality of life [ Time Frame: Approximately 24 weeks ]
Same as current
Not Provided
Not Provided
 
Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML.

II. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery).

SECONDARY OBJECTIVES:

I. To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.

ARM II: Patients undergo usual care for 4 weeks.

After completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • 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)
  • Recurrent Adult Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Other: counseling intervention
    Receive lifestyle-related counseling
    Other Name: counseling and communications studies
  • Behavioral: exercise intervention
    Undergo physical activity intervention
  • Other: educational intervention
    Receive educational materials
    Other Name: intervention, educational
  • Procedure: standard follow-up care
    Undergo usual care
  • Experimental: Arm I (physical activity)
    Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.
    Interventions:
    • Procedure: quality-of-life assessment
    • Other: counseling intervention
    • Behavioral: exercise intervention
    • Other: educational intervention
  • Active Comparator: Arm II (usual care)
    Patients undergo usual care for 4 weeks.
    Interventions:
    • Procedure: quality-of-life assessment
    • Procedure: standard follow-up care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria
  • Planned induction chemotherapy
  • Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain)
  • Patient must be ambulatory or able to walk with a cane
  • Patients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer Mental Status Scale)
  • Adequate English skills to understand and complete questionnaires
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)
  • Inability to ambulate
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01519596
CCCWFU 97711
NCI-2012-00003 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: Heidi Klepin Wake Forest University Health Sciences
Wake Forest University Health Sciences
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP