멈출 시간이 없습니다: 중년 히스패닉 여성의 건강을 개선하기 위한 신체 활동
멈출 시간이 없습니다: 폐경기 전환기 중년 히스패닉 여성의 건강과 웰빙을 개선하기 위한 신체 활동
This study will test the effects of a physical activity intervention among midlife Hispanic women.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The menopausal transition in midlife is a critical juncture where women experience life transitions and adverse physiological and psychological changes that increase the risk for hypertension and cardiovascular diseases in later life. Physical activity improves blood pressure, biomarkers of hypertension, sleep, mood, and well-being; however, Hispanic women meet physical activity recommendations at lower levels than non-Hispanic White women. The investigator will examine the feasibility of the physical activity intervention among sedentary midlife Hispanic women in the menopausal transition with elevated blood pressure, exploring changes in physical activity and health.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Lisa Thibodeaux, BSN, RNC-OB
- 전화번호: 409-747-1756
- 이메일: lbthibod@utmb.edu
연구 장소
-
-
Texas
-
Galveston, Texas, 미국, 77555
- University of Texas Medical Branch, Galveston
-
연락하다:
- Lisa Thibodeaux
- 이메일: lbthibod@utmb.edu
-
수석 연구원:
- Elizabeth Lorenzo, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female
- Hispanic by self-report
- Able to speak and read English
- Sedentary
- Age 45-50
- Diagnosed with elevated blood pressure or objectively measured systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg averaged from ≥ 2 measures on ≥ 2 outpatient visits
- Symptoms consistent with the menopause transition (persistent difference of ≥7 days in the length of consecutive cycles; persistence is defined as recurrence within 10 cycles of the first variable length cycle)
- Apparently healthy
- Self-reported ability to engage in moderate intensity physical activity
- Access to a smart device that is compatible with a Fitbit application
Exclusion Criteria:
- Self-reported physical activity of ≥150 minutes per week
- Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire
- Post-menopausal (12-months without a menstrual cycle)
- Diagnosed hypertension
- Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers
- Previous hysterectomy, oophorectomy, and/or uterine ablation
- Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia
- Hormonal medication via any route or implants
- Tamoxifen
- Pregnant, planning to become pregnant, or breastfeeding
- Planning to move out of the Galveston/Houston area in the next 18 months
- Current participation in another physical activity study or program
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Physical activity intervention
Multi-level intervention to increase physical activity |
Physical activity |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Days the activity monitor was worn
기간: Baseline to 6-months
|
Objectively measured days the wearable activity monitor was worn during the intervention period |
Baseline to 6-months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
기간: Baseline to 6-months
|
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 6-months
|
|
Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months
기간: Baseline to 12-months
|
Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 12-months
|
|
Physical activity as measured by minutes of moderate intensity physical activity at 6 months
기간: Baseline to 6-months
|
Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 6-months
|
|
Physical activity as measured by minutes of moderate intensity physical activity at 6 months
기간: Baseline to 12-months
|
Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 12-months
|
|
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
기간: Baseline to 6-months
|
Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 6-months
|
|
Physical activity as measured by minutes of vigorous intensity physical activity at 6 months
기간: Baseline to 12-months
|
Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 12-months
|
|
Physical activity as measured by minutes of light intensity physical activity at 6 months
기간: Baseline to 6-months
|
Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 6-months
|
|
Physical activity as measured by minutes of light intensity physical activity at 6 months
기간: Baseline to 12-months
|
Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period |
Baseline to 12-months
|
|
Physical activity as measured by minutes of total physical activity at 6 months
기간: Baseline to 6-months
|
Mean daily minutes of total physical activity taken from accelerometers for a 7 day period |
Baseline to 6-months
|
|
Physical activity as measured by minutes of total physical activity at 6 months
기간: Baseline to 12-months
|
Mean daily minutes of total physical activity taken from accelerometers for a 7 day period |
Baseline to 12-months
|
|
Systolic blood pressure
기간: Baseline to 6-months
|
Change in systolic blood pressure (mmHg) |
Baseline to 6-months
|
|
Systolic blood pressure
기간: Baseline to 12-months
|
Change in systolic blood pressure (mmHg) |
Baseline to 12-months
|
|
Diastolic blood pressure
기간: Baseline to 6-months
|
Change in diastolic blood pressure (mmHg) |
Baseline to 6-months
|
|
Diastolic blood pressure
기간: Baseline to 12-months
|
Change in diastolic blood pressure (mmHg) |
Baseline to 12-months
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Abdominal circumference
기간: Baseline to 6-months
|
Change in abdominal circumference (cm) |
Baseline to 6-months
|
|
Abdominal circumference
기간: Baseline to 12-months
|
Change in abdominal circumference (cm) |
Baseline to 12-months
|
|
Body mass index
기간: Baseline to 6-months
|
Change in body mass index (kg/m2) |
Baseline to 6-months
|
|
Body mass index
기간: Baseline to 12-months
|
Change in body mass index (kg/m2) |
Baseline to 12-months
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Elizabeth Lorenzo, PhD, RN, University of Texas
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 23-0320
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The research data from this project will be deposited with a service of the Inter-university Consortium for Political and Social Research (ICPSR), openICPSR, to ensure that the research community has long-term access to the data.
IPD 공유 기간
We agree to deposit and/or make available our data upon completion of the clinical trial and acceptance of the data for publication. Data will be stored in the repository for at least 3 years, as required by federal retention guidelines.
IPD 공유 액세스 기준
Data will be shared via openICPSR as open access.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .