NCT01519596

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

Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-03-05
• Completion: 2017-02-05
• First posted: 2012-01-27
• Last updated: 2019-08-16

Locations

1 site across 1 country: United States