Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women

NCT ID: NCT04546100

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed Description

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:

In this study, a longitudinal and long-term follow-up randomized controlled trial study was adopted. The case was collected in a postpartum ward and an obstetrics and gynecology clinic of a medical center in the north Taiwan. The mothers who met the conditions for sample selection were selected as the research object. There are two different intervention modes (intervention group and control group), the intervention group is a Maternal-Infant Exercise Program, and the control group receives routine postpartum exercise nursing guidance. There are 50 people in each group. It is estimated that 100 healthy women with vagina postpartum will be collected. The questionnaires and physiological measurements are used to collect and aggregate the data. The main research variables are the Maternal-Infant Exercise Program, and the dependent variables are the postpartum women's body composition, stress, fatigue and parent-child attachment. The body composition of postpartum women is measured using a body fat meter, postpartum stress is measured using a Perceived Stress Scale(PSS), postpartum fatigue is measured using a Modified Fatigue Symptoms Checklist(MFSC), and the parent-child attachment relationship is measured using the Maternal Attachment Inventory(MAI). The two groups will collect data at one month, two months and three months after delivery, including body composition measurement and filling in each scale. The analysis method of the research data will use SPSS version 22.0 software, using chi-square test, independent sample t test , Pearson correlation, generalized estimation equations for discussion of results.

Result:

This study expects to understand the current status of postpartum women's body composition, stress, fatigue, and parent-child attachment. It is expected that parent-child exercise programs will improve postpartum women's body composition, as well as improve stress, fatigue, and enhance parent-child attachment.

Conditions

Postpartum; Body Composition; Stress; Fatigue; Attachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Maternal-Infant Exercise Program

In the postpartum period, give the intervention group "Maternal-Infant Exercise Program" and encourage them to do exercise. The "Parent-Child Exercise Program" can be divided into three stages. Videos will be provided in each stage. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.

Group Type: EXPERIMENTAL

Maternal-Infant Exercise Program

Intervention Type: OTHER

"Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.

Regular postpartum exercise guidance

Another group will receive "Regular postpartum exercise guidance". The guidance includes chest exercises, neck exercises, leg exercises, hip exercises, abdominal exercises, vagina contraction exercises, and uterine contraction exercises, starting from the third day after delivery to one month after delivery. The detail information will refer to the General Hospital of Tri-Services Provided the postpartum health education manual-postpartum exercise (p.8-10)

Group Type: PLACEBO_COMPARATOR

Maternal-Infant Exercise Program

Intervention Type: OTHER

"Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.

Interventions

Maternal-Infant Exercise Program

"Maternal-Infant Exercise Program" can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Postpartum healthy women with vaginal delivery

2. No obstetric complications

3. Taiwanese, understand Chinese

4. Agreed to participate in the research after the explanation, and agreed to receive four questionnaire surveys

5. The baby's gestational weeks are more than 37 weeks and the birth weight is more than 2500 grams

6. The baby has no complications or no congenital abnormalities

Exclusion Criteria

1. Four-degree laceration of the perineal wound

2. A history of serious medical and surgical diseases cannot perform exercise

3. Those who cannot cooperate with the implementation of the parent-child exercise program at least three days a week, 20-30 minutes each time

4. The infant must be hospitalized for observation after being evaluated by a doctor and cannot be discharged

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Hsiang-Yun Lan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

TSGH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsiang-Yun Lan, Asst. Prof.

Role: CONTACT

shinnylan@msn.com

87923311 ext. 18781

Facility Contacts

Hsiang-Yun Lan, Asst. Prof.

Role: primary

shinnylan@msn.com

87923311 ext. 18781

Other Identifiers

1-2020-07-16

Identifier Type: -

Identifier Source: org_study_id