- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04072133
The Move Well Study (MW)
Effects of Meditative Movement on Body Composition in Midlife Women
연구 개요
상세 설명
A growing body of published evidence indicates that meditative movement (MM) practices may be helpful for body composition improvement. Less strenuous forms of exercise that include a focus on the breath and meditative state (i.e., "meditative movement" such as Yoga, Qigong, or Tai Chi) may be easier to adopt for unfit, sedentary, overweight or obese women, which characterizes a large percentage of the general population. Despite this preliminary evidence, no studies have proposed a model for how or why weight loss might occur in MM interventions where the goals are not designated as weight loss, nutritional counseling is not included, and energy expenditure is not at the level assumed to be required to achieve weight loss. The proposed intervention is designed to refine and gather preliminary evidence for a novel "mindful-body-wisdom" model of intervening on improving body composition and to examine the contribution of model factors (psychological and behavioral) of how such a non-diet/non-vigorous exercise intervention might work, in 60 midlife women.
TCE is a simple TC/QG form that was developed by Dr. Roger Jahnke and developed into a standardized research intervention protocol by a team of researchers. It has been used in several prior projects and one recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors showing reduction in fatigue and depression, and improved sleep and physical function.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Arizona
-
Phoenix, Arizona, 미국, 85004
- Arizona State University Downtown Campus
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female
- 45-75 years of age
- Ability to participate in low intensity activity
Exclusion Criteria:
- Women who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak)
- Women who are unable to walk
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Meditative Movement Intervention
Participants will complete the following components of baseline (T1) data collection: demographics, biometric measurements, a heart rate variability assessment, and questionnaires.
Participants will be asked to provide six saliva samples via passive drool to measure cortisol levels.
Participants will be assigned into hour-long meditative movement (MM) classes for eight weeks total.
Participants will be asked to practice their MM skills at home for at least 30 minutes most days per week.
The study will distribute hard-copy movement manuals and DVD instruction videos for guidance.
Participants will be asked to provide a log of all dates and lengths of their at-home practice.
After the eighth class, participants will return for post-intervention (T2) data collection, consisting of biometric measurements, a heart rate variability assessment, and questionnaires.
Participants will provide six more saliva samples via passive drool method.
|
Intervention will be taught by a certified Tai Chi Easy (TCE) group practice leader.
The TCE movements will be repeated in differing sequences and time-frames during the course of the study.
The variety and combination of the exercises will begin easy and progress to more advanced movements and/or intensities as the study progresses and participants become more experienced and comfortable with the routine.
Participants spend one hour in class each week for a total of eight weeks.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Body Fat Percentage
기간: 8 weeks
|
Body fat percentage will be measured using Bioelectric Impedance Analysis (BIA) via the Tanita monitor.
Score range= 0% to 100%.
A higher score indicates a higher body fat percentage.
|
8 weeks
|
Emotional Eating
기간: 8 weeks
|
Emotional eating will be measured using the Three Factor Eating Questionnaire (TFEQ) (21 items, 4-point Likert scale with response options 1 through 4 for items 1 through 17, response options 1 through 8 for item 18).
Score range= 18 to 76. Emotional eating sub-score is calculated by combining six items of the TFEQ.
A higher score indicates greater emotional eating.
|
8 weeks
|
Sleep Quality
기간: 8 weeks
|
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) (10 items, 4-point Likert scale; 0= positive extreme of scale, 3= negative extreme of scale).
Score range= 0 to 21.
A higher score indicates worse sleep quality.
|
8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Perceived Stress Scale-10
기간: 8 weeks
|
self-report measure of perceived stress, 10-items, Likert scale
|
8 weeks
|
Self-Compassion Scale (SCS)
기간: 8 weeks
|
self-report measure of self-compassion as measured (26 items) by self-kindness, common humanity, non-judgment
|
8 weeks
|
Body Awareness Questionnaire (BAQ)
기간: 8 weeks
|
self-report measure of experienced body awareness/iteroception, 18-items, Likert-scale
|
8 weeks
|
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
기간: 8 weeks
|
self-report measure of mindfulness, Likert-scale, 9-items
|
8 weeks
|
공동 작업자 및 조사자
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Meditative Movement에 대한 임상 시험
-
University of Alabama at Birmingham완전한
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for... 그리고 다른 협력자들완전한
-
Natália Maria Oliveira Campelo완전한병리학적 과정 | 근골격계 질환 | 관절 질환 | 골관절염 고관절
-
Universidade Federal de Sao CarlosCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.완전한
-
University of VermontEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Cliniques universitaires Saint-Luc- Université...모병