NCT04546100

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 4, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

August 3, 2020

Last Update Submit

September 10, 2020

Conditions

PostpartumBody CompositionStressFatigueAttachment

Keywords

postpartummaternal-infant exercise programbody compositionstressfatigueattachment

Outcome Measures

Primary Outcomes (36)

  • Body Composition- weight-T1

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Maternal-Infant Exercise Program

EXPERIMENTAL

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.

Other: Maternal-Infant Exercise Program

Regular postpartum exercise guidance

PLACEBO COMPARATOR

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)

Other: Maternal-Infant Exercise Program

Interventions

Maternal-Infant Exercise ProgramOTHER

"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.

Maternal-Infant Exercise ProgramRegular postpartum exercise guidance

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TSGH

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hsiang-Yun Lan, Asst. Prof.

CONTACT

87923311shinnylan@msn.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2020

First Posted

September 11, 2020

Study Start

August 4, 2020

Primary Completion

July 30, 2021

Study Completion

December 31, 2021

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)