South Asian Women & Yoga Education Study (SAWYES)
2012년 11월 16일 업데이트: Dr. Amandah Hoogbruin, Kwantlen Polytechnic University
Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study
The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12 week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for cardiovascular disease.
Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques.
The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.
연구 개요
연구 유형
중재적
등록 (예상)
50
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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British Columbia
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Surrey, British Columbia, 캐나다, V3T 0G9
- 모병
- The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
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연락하다:
- Amandah L Hoogbruin, PhD
- 전화번호: 604 599 3144
- 이메일: amandah.hoogbruin@kwantlen.ca
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연락하다:
- Raymond Dong, FRCP(c)
- 전화번호: 604 686 6372
- 이메일: raydongheart@gmail.com
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Surrey, British Columbia, 캐나다, V3W 2M8
- 아직 모집하지 않음
- Kwantlen Polytechnic University
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연락하다:
- Amandah L Hoogbruin, PhD
- 전화번호: 604 599 3144
- 이메일: amandah.hoogbruin@kwantlen.ca
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연락하다:
- Raymond Dong, FRCPC
- 전화번호: 604 838 8418
- 이메일: raydongcardio@gmail.com
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수석 연구원:
- Amandah L Hoogbruin, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- 40- 65 years old
- Postmenopausal (amenorrhea for ≥ 12 months)
- Overweight as evidenced by a body mass index (BMI) ≥ 25 kg/m2), or waist circumference ≥ 80 cm, or have a first degree relative with diabetes or essential hypertension
- Sedentary, do not do a regular exercise program (exercising for 20 minutes at sufficient intensity to produce sweating less than 2x/week)
- Self-identify as a South Asian (sometimes referred to as East Indian in Canada and may be defined "as any person who reports an ethnicity associated with the southern part of Asia or who self-identifies as part of the South Asian visible minority group. This definition encompasses people from a great diversity of ethnic backgrounds, including those with Bangladeshi, Bengali, East Indian, Goan, Gujarati, Hindu, Ismaili, Kashmiri, Nepali, Pakistani, Punjabi, Sikh, Sinhalese, South Asian, Sri Lankan and Tamil ancestry. South Asians may have been born in Canada, on the Indian sub-continent, in the Caribbean, in Africa, in Great Britain or elsewhere
- Given consent to research protocol and willingness to be randomized to either the treatment (yoga) or control (no yoga) group.
Exclusion Criteria:
- Have had a period within the last year
- Are not between the ages of 40 and 65
- Have experience with yoga within the last 12 months
- Have any serious disease or condition such as diabetes, serious high blood pressure or heart problems, kidney disease, severe asthma, cancer (except for skin cancer that is not melanoma)
- Have a major brain or nervous system diagnosis, such as Parkinson's disease or stroke
- Have a severe infectious or other medical illness right now such as pneumonia
- Use medications to lower blood sugar levels
- Have serious back, hip, or neck problems or pain in joints or bones that would prevent the safe completion of a gentle 12 week Hatha yoga program
- Regularly use an assistive device (e.g., cane, walker) to walk
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
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실험적: 요가 개입
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12 week 90 minute hatha yoga session offered three (3x) per week.
Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques.
The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in blood pressure
기간: baseline, at end of study (12 wks), & 3 months post-study
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blood pressure is measured as a specific physiologic index of cardiovascular risk.
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baseline, at end of study (12 wks), & 3 months post-study
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in subjective well-being
기간: baseline, at end of study (12 wks), & 3 months post-study
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The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.
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baseline, at end of study (12 wks), & 3 months post-study
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Change in perceived physical well-being
기간: baseline, end of study (12 wks) & 3 months post-study
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Pittsburgh Sleep Quality Index, Physical Activity Scale for the Elderly, and Exercise Regularly Scale will be used to measure change in perceived physical well-being
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baseline, end of study (12 wks) & 3 months post-study
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Change in insulin sensitivity
기간: baseline, end of study (12 wks) & 3 months post-study
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Fasting insulin & glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in inflammation
기간: baseline, end of study (12 wks) & 3 months post-study
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C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in serum total cholesterol
기간: baseline, end of study (12 wks) & 3 months post-study
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Serum total cholesterol will be measured as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in serum high-density lipoprotein (HDL) cholesterol
기간: baseline, end of study (12 wks) & 3 months post-study
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Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in serum low-density lipoprotein (LDL) cholesterol
기간: baseline, end of study (12 wks) & 3 months post-study
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Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in serum triglycerides
기간: baseline, end of study (12 wks) & 3 months post-study
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Serum triglycerides will be measured as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in waist circumference.
기간: baseline, end of study (12 wks) & 3 months post-study
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Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change waist-hip ratio
기간: baseline, end of study (12 wks) & 3 months post-study
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Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in body mass index (BMI)
기간: baseline, end of study (12 wks) & 3 months post-study
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Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in resting heart rate
기간: baseline, end of study (12 wks) & 3 months post-study
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Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
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baseline, end of study (12 wks) & 3 months post-study
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Change in heart rate
기간: baseline, at end of study (12 wks), & 3 months post-study
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Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
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baseline, at end of study (12 wks), & 3 months post-study
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Amandah L Hoogbruin, PhD, Kwantlen Polytechnic University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 11월 1일
기본 완료 (예상)
2014년 12월 1일
연구 완료 (예상)
2015년 8월 1일
연구 등록 날짜
최초 제출
2012년 6월 17일
QC 기준을 충족하는 최초 제출
2012년 8월 14일
처음 게시됨 (추정)
2012년 8월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 11월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 11월 16일
마지막으로 확인됨
2012년 11월 1일
추가 정보
이 연구와 관련된 용어
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. .