Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
SECONDARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
TERTIARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
OUTLINE:
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
After completion of study, patients are followed up for 16 weeks.
After completion of study, patients are followed up for 16 weeks.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90033
- USC / Norris Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical stage I EC
- Low grade disease positive for estrogen and progesterone receptors
- Body mass index (BMI) >= 30 kg/m^2
- No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Self ambulatory and without use of assistive walking devices
- Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)
- Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Exclusion Criteria:
- Patients with metastatic disease
- BMI =< 29.9 kg/m^2
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is not self ambulatory and relies on the use of assistive walking devices
- Is a candidate for immediate hysterectomy, following evaluation by a physician
- In judgement of a physician, is not a candidate for progestin agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Supportive Care (exercise and diet)
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks.
Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
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상관 연구
보조 연구
다른 이름들:
Undergo DASH diet
다른 이름들:
Undergo in aerobic exercise
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiorespiratory Fitness (CRF)
기간: Up to 34 weeks
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Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
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Up to 34 weeks
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Cardiovascular (CV) health outcomes
기간: Up to 34 weeks
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Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound.
The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
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Up to 34 weeks
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Depression measured by Center for Epidemiologic Studies Depression scale
기간: Up to 34 weeks
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Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
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Up to 34 weeks
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Fatigue measured by the Brief Fatigue Inventory
기간: Up to 34 weeks
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Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
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Up to 34 weeks
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Muscle strength
기간: Up to 34 weeks
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The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
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Up to 34 weeks
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Percent weight loss at the completion of the intervention
기간: At 16 weeks
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Each of the 25 women will be classified as having achieve the 10% weight-loss or not.
Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated.
The mean percent weight loss, as well as the range and quartiles will be calculated.
In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g.
inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.).
This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
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At 16 weeks
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Quality of Life (QOL)
기간: Up to 34 weeks
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The SF-36 short-form health survey with 36 items will be used to assess physical and mental health.
The FACT-En questionnaire will also be used.
This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
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Up to 34 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christina Dieli-Conwright, PhD, University of Southern California
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 5U-16-1 (기타 식별자: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (미국 NIH 보조금/계약)
- NCI-2016-01684 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
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