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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01519596
Collaborator
National Cancer Institute (NCI) (NIH)
70
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2
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Study Details

Study Description

Brief Summary

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.

Detailed Description

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

  2. 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:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Mar 5, 2015
Actual Study Completion Date :
Feb 5, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
  • Other: counseling intervention
    Receive lifestyle-related counseling
    Other Names:
  • counseling and communications studies
  • Behavioral: exercise intervention
    Undergo physical activity intervention

    Other: educational intervention
    Receive educational materials
    Other Names:
  • intervention, educational
  • Active Comparator: Arm II (usual care)

    Patients undergo usual care for 4 weeks.

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment
  • Procedure: standard follow-up care
    Undergo usual care

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility, in terms of participation rates and barriers to recruitment and retention [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.

    2. Magnitude and trajectory of changes in objective physical function [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.

    Secondary Outcome Measures

    1. Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength [Approximately 4 weeks]

    2. Self-reported quality of life [Approximately 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Heidi Klepin, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01519596
    Other Study ID Numbers:
    • IRB00019467
    • NCI-2012-00003
    • CCCWFU 97711
    First Posted:
    Jan 27, 2012
    Last Update Posted:
    Aug 16, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2019