Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Feasibility, in terms of participation rates and barriers to recruitment and retention
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)
- •Inability to ambulate
研究组 & 干预措施
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.
干预措施: quality-of-life assessment (Procedure)
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.
干预措施: counseling intervention (Other)
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.
干预措施: exercise intervention (Behavioral)
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.
干预措施: educational intervention (Other)
Arm II (usual care)
Patients undergo usual care for 4 weeks.
干预措施: quality-of-life assessment (Procedure)
Arm II (usual care)
Patients undergo usual care for 4 weeks.
干预措施: standard follow-up care (Procedure)
结局指标
主要结局
Feasibility, in terms of participation rates and barriers to recruitment and retention
时间窗: Approximately 4 weeks
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.
Magnitude and trajectory of changes in objective physical function
时间窗: Approximately 4 weeks
Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.
次要结局
- 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)