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临床试验/NCT04546100
NCT04546100Unknown不适用

Effects of a Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women:A Randomized Control Trial

National Defense Medical Center, Taiwan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年8月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Body Composition- weight-T2

研究概览

简要总结

The aim of this study is to explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

详细描述

Background:

In Taiwan, more than 50% of maternal women will encounter obesity problems, because they have to take care of newborns, lack of proper exercise, and the traditional concept of confinement leads to excessive dietary supplementation, basal metabolic rate decline, and insufficient exercise. In addition to the physical changes after birth, women also face the change of the role of mothers. Caring for newborns is almost 24 hours on standby, gradually forming stress and fatigue. Stress may make postpartum women unable to perform the tasks of mothers. Makes postpartum women feel physiologically and psychologically uncomfortable. Both stress and fatigue have an adverse effect on their health, and are not conducive to parent-child attachment. However, early postpartum mothers and infants are almost inseparable. This period of attachment often affects infants' interpersonal relationships and emotions, if the relationship is not harmonious, may cause deviations in the baby's future behavior. Many studies have pointed out that moderate exercise can not only reduce the fatigue of postpartum women but also help to restore physical strength, help the recovery of organs and body, maintain physical health and weight management. However, busy with baby care and lack of continuous exercise often lead to postpartum women unable to reduce body weight. Therefore, this study hopes to develop a "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress and fatigue, and to improve the attachment relationship between parents and their infants.

Purposes:

Explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

Method:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postpartum healthy women with vaginal delivery
  • No obstetric complications
  • Taiwanese, understand Chinese
  • Agreed to participate in the research after the explanation, and agreed to receive four questionnaire surveys
  • The baby's gestational weeks are more than 37 weeks and the birth weight is more than 2500 grams
  • The baby has no complications or no congenital abnormalities

排除标准

  • Four-degree laceration of the perineal wound
  • A history of serious medical and surgical diseases cannot perform exercise
  • Those who cannot cooperate with the implementation of the parent-child exercise program at least three days a week, 20-30 minutes each time
  • The infant must be hospitalized for observation after being evaluated by a doctor and cannot be discharged

结局指标

主要结局

Body Composition- weight-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).

Body Composition- weight-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).

Body Composition- weight-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).

Body Composition- weight-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: weight(kg).

Body Composition- body mass index-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).

Body Composition- body mass index-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).

Body Composition- body mass index-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).

Body Composition- body mass index-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body mass index(kg/m2).

Body Composition- body fat-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%).

Body Composition- body fat-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%).

Body Composition- body fat-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data: body fat percentage(%).

Body Composition- body fat-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body fat percentage(%).

Body Composition- body water-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).

Body Composition- body water-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).

Body Composition- body water-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).

Body Composition- body water-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body water(%).

Body Composition- muscle mass-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).

Body Composition- muscle mass-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).

Body Composition- muscle mass-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).

Body Composition- basal metabolic rate(BMR)-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).

Body Composition- muscle mass-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:muscle mass(kg).

Body Composition- bone mass-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).

Body Composition- bone mass-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).

Body Composition- bone mass-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).

Body Composition- bone mass-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:bone mass(kg).

Body Composition- basal metabolic rate(BMR)-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).

Body Composition- basal metabolic rate(BMR)-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).

Body Composition- basal metabolic rate(BMR)-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:basal metabolic rate(kcal).

Body Composition- body age-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).

Body Composition- body age-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).

Body Composition- body age-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).

Body Composition- body age-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:body age(age).

Body Composition- Visceral fat-T1

时间窗: T1-baseline

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).

Body Composition- Visceral fat-T2

时间窗: T2-one month later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).

Body Composition- Visceral fat-T3

时间窗: T3-two months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).

Body Composition- Visceral fat-T4

时间窗: T4-three months later

This study uses a body fat meter(TANITA BC-545N), and the Ministry of Health Medical Device Input No. 028886, which has been calibrated by the manufacturer before use. This device record data:visceral fat (level).

次要结局

  • Postpartum stress-T1(T1-baseline)
  • Postpartum stress-T2(T2-one month later)
  • Postpartum stress-T3(T3-two months later)
  • Postpartum stress-T4(T4-three months later)
  • Postpartum fatigue-T1(T1-baseline)
  • Postpartum fatigue-T2(T2-one month later)
  • Postpartum fatigue-T3(T3-two months later)
  • Postpartum fatigue-T4(T4-three months later)
  • Attachment-T1(T1-baseline)
  • Attachment-T2(T2-one month later)
  • Attachment-T3(T3-two months later)
  • Attachment-T4(T4-three months later)

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiang-Yun Lan

Assistant Professor

National Defense Medical Center, Taiwan

研究点 (1)

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