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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00003 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 97711 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (physical activity) | Experimental | 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 (usual care) | Active Comparator | Patients undergo usual care for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality-of-life assessment | Procedure | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength | Approximately 4 weeks | |
| Self-reported quality of life | Approximately 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Klepin | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40737540 | Derived | Klepin HD, Tooze JA, Rejeski WJ, Mihalko S, Pardee TS, Ellis L, Howard D, 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 Oct 28;9(20):5152-5163. doi: 10.1182/bloodadvances.2025016260. |
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| counseling intervention | Other | Receive lifestyle-related counseling |
|
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| exercise intervention | Behavioral | Undergo physical activity intervention |
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| educational intervention | Other | Receive educational materials |
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| standard follow-up care | Procedure | Undergo usual care |
|
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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