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Programa de ejercicio materno-infantil sobre composición corporal, estrés, fatiga y apego en mujeres posparto

16 de septiembre de 2026 actualizado por: Hsiang-Yun Lan, National Defense Medical Center, Taiwan

Efectos de un programa de ejercicio materno-infantil sobre la composición corporal, el estrés, la fatiga y el apego en mujeres posparto: un ensayo de control aleatorizado

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

81

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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.
Comparador de placebos: 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)
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body Composition- weight-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- weight-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- weight-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- weight-T4
Periodo de tiempo: 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).
T4-three months later
Body Composition- body mass index-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- body mass index-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- body mass index-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- body mass index-T4
Periodo de tiempo: 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).
T4-three months later
Body Composition- body fat-T1
Periodo de tiempo: 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(%).
T1-baseline
Body Composition- body fat-T2
Periodo de tiempo: 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(%).
T2-one month later
Body Composition- body fat-T3
Periodo de tiempo: 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(%).
T3-two months later
Body Composition- body fat-T4
Periodo de tiempo: 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(%).
T4-three months later
Body Composition- body water-T1
Periodo de tiempo: 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(%).
T1-baseline
Body Composition- body water-T2
Periodo de tiempo: 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(%).
T2-one month later
Body Composition- body water-T3
Periodo de tiempo: 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(%).
T3-two months later
Body Composition- body water-T4
Periodo de tiempo: 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(%).
T4-three months later
Body Composition- muscle mass-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- muscle mass-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- muscle mass-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- muscle mass-T4
Periodo de tiempo: 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).
T4-three months later
Body Composition- bone mass-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- bone mass-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- bone mass-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- bone mass-T4
Periodo de tiempo: 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).
T4-three months later
Body Composition- basal metabolic rate(BMR)-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- basal metabolic rate(BMR)-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- basal metabolic rate(BMR)-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- basal metabolic rate(BMR)-T4
Periodo de tiempo: 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).
T4-three months later
Body Composition- body age-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- body age-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- body age-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- body age-T4
Periodo de tiempo: 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).
T4-three months later
Body Composition- Visceral fat-T1
Periodo de tiempo: 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).
T1-baseline
Body Composition- Visceral fat-T2
Periodo de tiempo: 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).
T2-one month later
Body Composition- Visceral fat-T3
Periodo de tiempo: 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).
T3-two months later
Body Composition- Visceral fat-T4
Periodo de tiempo: 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).
T4-three months later

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postpartum stress-T1
Periodo de tiempo: T1-baseline

The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
T1-baseline
Postpartum stress-T2
Periodo de tiempo: T2-one month later

The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
T2-one month later
Postpartum stress-T3
Periodo de tiempo: T3-two months later

The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
T3-two months later
Postpartum stress-T4
Periodo de tiempo: T4-three months later

The Perceived Stress Scale(PSS) has 14 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum stress.
T4-three months later
Postpartum fatigue-T1
Periodo de tiempo: T1-baseline

The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
T1-baseline
Postpartum fatigue-T2
Periodo de tiempo: T2-one month later

The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
T2-one month later
Postpartum fatigue-T3
Periodo de tiempo: T3-two months later

The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
T3-two months later
Postpartum fatigue-T4
Periodo de tiempo: T4-three months later

The Modified Fatigue Symptoms Checklist(MFSC) has 10 questions on the scale. The questions use a response level of 0 to 4. The 0 point means never, 1 point means occasionally, 2 points means sometimes, 3 points means often,and 4 points means always. The higher the total score, the greater the postpartum fatigue.
T4-three months later
Attachment-T1
Periodo de tiempo: T1-baseline

The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
T1-baseline
Attachment-T2
Periodo de tiempo: T2-one month later

The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
T2-one month later
Attachment-T3
Periodo de tiempo: T3-two months later

The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
T3-two months later
Attachment-T4
Periodo de tiempo: T4-three months later

The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often. The higher the total score, the closer the maternal-infant attachment.
T4-three months later

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Defense Medical Center, Taiwan

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de agosto de 2020

Finalización primaria (Actual)

30 de julio de 2021

Finalización del estudio (Actual)

31 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2020

Primero enviado que cumplió con los criterios de control de calidad

10 de septiembre de 2020

Publicado por primera vez (Actual)

11 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1-2020-07-16

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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