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

Recurrent Adult Acute Myeloid Leukemia Clinical Trial

Official title:

Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519596
• Other study ID #: IRB00019467
• Secondary ID: NCI-2012-00003CC
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: February 5, 2017

Study information

• Verified date: August 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 5, 2017
• Est. primary completion date: March 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrent Adult Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Intervention

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• counseling intervention
Receive lifestyle-related counseling

Behavioral:
• exercise intervention
Undergo physical activity intervention

Other:
• educational intervention
Receive educational materials

Procedure:
• standard follow-up care
Undergo usual care

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, in terms of participation rates and barriers to recruitment and retention	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
Primary	Magnitude and trajectory of changes in objective physical function	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	Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength		Approximately 4 weeks
Secondary	Self-reported quality of life		Approximately 24 weeks