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

NCT ID: NCT01519596

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-02-05

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

counseling intervention

Intervention Type: OTHER

Receive lifestyle-related counseling

exercise intervention

Intervention Type: BEHAVIORAL

Undergo physical activity intervention

educational intervention

Intervention Type: OTHER

Receive educational materials

Arm II (usual care)

Patients undergo usual care for 4 weeks.

Group Type: ACTIVE_COMPARATOR

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

standard follow-up care

Intervention Type: PROCEDURE

Undergo usual care

Interventions

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

counseling intervention

Receive lifestyle-related counseling

Intervention Type: OTHER

exercise intervention

Undergo physical activity intervention

Intervention Type: BEHAVIORAL

educational intervention

Receive educational materials

Intervention Type: OTHER

standard follow-up care

Undergo usual care

Intervention Type: PROCEDURE

Other Intervention Names

quality of life assessment; counseling and communications studies; intervention, educational

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Klepin

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

Klepin HD, Tooze JA, Rejeski WJ, Mihalko SL, Pardee TS, Ellis LR, Howard DS, Demark-Wahnefried W, Powell BL, Kritchevsky S. Pilot study of an inpatient physical activity intervention for older adults treated intensively for acute myeloid leukemia. Blood Adv. 2025 Jul 30:bloodadvances.2025016260. doi: 10.1182/bloodadvances.2025016260. Online ahead of print.

Reference Type: DERIVED

PMID: 40737540 (View on PubMed)

Other Identifiers

NCI-2012-00003

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 97711

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00019467

Identifier Type: -

Identifier Source: org_study_id