- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00554489
Physical Activity in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia
RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.
PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.
연구 개요
상세 설명
OBJECTIVES:
Primary
- To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy.
Secondary
- To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients.
OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments.
Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 .
After completion of study intervention, patients are followed for 4 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
North Carolina
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Winston-Salem, North Carolina, 미국, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML) by WHO criteria
- Planning to undergo induction or reinduction chemotherapy
- Inpatient status at Wake Forest University Baptist Medical Center
- Must not require intensive care unit support
PATIENT CHARACTERISTICS:
- Able to understand English
- Medical eligibility confirmed with Leukemia Service Attending
- Ambulatory or able to walk with a cane
- No hemodynamic instability
- No acute thrombosis within the past 7 days
- No active ischemia within the past 7 days
- No uncontrolled pain
- Must have < 3 incorrect responses on the Pfeiffer Mental Status Exam
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study
기간: day 1
|
day 1
|
Percentage of eligible patients recruited into the study
기간: day 1
|
day 1
|
Number and frequency of reported barriers to eligibility and enrollment
기간: day 1
|
day 1
|
Percentage of study participants who successfully completed the physical and the psychosocial measures
기간: week 13
|
week 13
|
Record barriers to completion of the physical activity program
기간: week 13
|
week 13
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Physical function as measured by the Short Physical Performance Battery (SPPB)
기간: week 13
|
week 13
|
Quality of Life as measured with the Distress Thermometer
기간: week 13
|
week 13
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Heidi D. Klepin, MD, Wake Forest University Health Sciences
- 수석 연구원: Shannon Mihalko, PhD, Wake Forest University Health Sciences
- 연구 의자: Suzanne C. Danhauer, PhD, Wake Forest University Health Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000573938
- CCCWFU-98107
- IRB00003355
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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