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

August 14, 2019 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 4 weeks
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.
Approximately 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
Time Frame: Approximately 4 weeks
Approximately 4 weeks
Self-reported quality of life
Time Frame: Approximately 24 weeks
Approximately 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 5, 2015

Study Completion (Actual)

February 5, 2017

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00019467
  • NCI-2012-00003 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 97711 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe