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

Brief Title

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

Official Title

Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy

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:

      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

Primary Outcome

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

Secondary Outcome

 Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength

Condition

Adult Acute Myeloid Leukemia in Remission

Intervention

quality-of-life assessment

Study Arms / Comparison Groups

 Arm I (physical activity)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

70

Start Date

October 2012

Completion Date

February 5, 2017

Primary Completion Date

March 5, 2015

Eligibility Criteria

        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
      

Gender

All

Ages

60 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Heidi Klepin, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01519596

Organization ID

IRB00019467

Secondary IDs

NCI-2012-00003

Responsible Party

Sponsor

Study Sponsor

Wake Forest University Health Sciences

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Heidi Klepin, Principal Investigator, Wake Forest University Health Sciences

Verification Date

August 2019