Aerobic Exercise on Prenatal Sleep Quality and Maternal-fetal Attachment

NCT04364919 | Completed

• 1 other identifier: NSC102-2314-B006-063-MY2
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

A growing body of evidence suggests that exercise is an important contributor to maternal health and is beneficial to infants. A single-blinded randomised experimental study was used to evaluate the effect of aerobic exercise on sleep quality and maternal-fetal attachment in pregnancy women. 140 eligible pregnant women were systematically assigned, with a random start to experimental group (n = 70) received a 20 minutes aerobic exercise video and was instructed to exercise at least three times a week for 3 months at home, while the control group (n = 70) received the usual care only. The Pittsburgh Sleep Quality Index and Modified Maternal-Fetal Attachment Scale were used to assess outcomes measured before the intervention and at 4 and 12 weeks postintervention. Paired sample t-tests were conducted before and after aerobic exercise to measure whether there were any statistically significant changes in outcome variables.

Conditions

Effects of Aerobic Exercise in Pregnant Women

Keywords

aerobic exercise; prenatal care; sleep quality; maternal-fetal attachment

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index (PSQI) was used to measure subjective sleep quality during pregnancy. The PSQI, developed by Buysse et al. (1989), contains 19 items and measures 7 components of sleep quality, including habitual sleep efficiency, sleep latency, sleep duration, sleep disturbances, use of sleep medication, daytime dysfunction, and subjective sleep quality. Each component is evaluated on a 4-point Likert scale, with 0 representing better sleep and 3 representing worse sleep. The summed scores range from 0 to 21, with scores over 5 indicating poor sleep quality and scores less than or equal to 5 indicating good sleep quality.

  12 weeks

• Modified Maternal-Fetal Attachment Scale

  The Modified Maternal-Fetal Attachment Scale (MMFAS) was used to measure maternal attachment to the fetus. The MMFAS was developed by merging the Muller's (1993) Prenatal Attachment Inventory with the Cranley's (1981) Maternal-Fetal Attachment Scale. The MMFAS Mandarin language version comprises 39 items addressing four factors: interacting with the fetus, giving of self, identifying the fetus, and fantasizing (Hsu \& Chen, 2001). Each item is ranked on a 5-point Likert scale, with 0 = never and 4 = always. Scores range from 0 to 156, with higher scores indicating greater maternal attachment.

  12 weeks

Study Arms (2)

aerobic exercise intervention

EXPERIMENTAL

The intervention group received a DVD with low-impact aerobic exercises developed by the researchers in collaboration with a qualified prenatal yoga teacher. With a soft musical background, the exercise actions were arranged in following order: warm-up → neck → shoulder → arm → chest → waist →leg → regulating the breathing. The first 14.5 minutes of the yoga exercises were performed in a sitting position, followed by 3.5 minutes in standing position, and then returning to 2 minutes in sitting position. The exercise program requires twenty minutes to complete. Women were instructed to use the DVD 3 times a week for 3 months.

Behavioral: aerobic exercise program

control group

NO INTERVENTION

The control group received routine prenatal care only.

Interventions

aerobic exercise program BEHAVIORAL

The program incorporated modified yoga movements suitable for pregnant women. The DVD provides an illustration with the written caption, "Please take enough water before exercise, and wear loose and comfortable clothes in a suitable environment. If you feel tired, stop exercising immediately." The DVD's narrator then says, "Now you are ready to prepare a comfortable, solid chair with a chair back." With a soft musical background, the exercise actions were arranged in following order: warm-up → neck → shoulder → arm → chest → waist →leg → regulating the breathing. The first 14.5 minutes of the yoga exercises were performed in a sitting position, followed by 3.5 minutes in standing position, and then returning to 2 minutes in sitting position. The exercises were developed as a progressive program in order to achieve the goals of strength-conditioning, moderate-intensity exercise (ACOG, 2015).

aerobic exercise intervention

Eligibility Criteria

• Age: 23 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Women were excluded if they reported any contraindications to aerobic exercise during pregnancy according to the 2015 ACOG guidelines.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Chung-Hey Chen, PhD

  College of Medicine, National Cheng-Kung University, Tainan, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: One hundred and forty women who met the inclusion criteria and returned their consent documents were systematically assigned, from a random starting point to experimental (n = 70) or a control (n = 70) group. Women usually talk to each other during the prenatal check and this could cause study data contamination, so we used a month as the unit of allocation to avoid between-group data contamination. The first month collecting data was control group decided by drawing lots (two lots which were marked "E" for experimental group and marked "C" for control group in a sack). Research assistant drew the lot from the sack. Then, the following month, group allotment was systematically assigned in sequence to either the experimental group or the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In addition to routine care, the experimental group was given a DVD and instructed to engage in the aerobic exercise program shown on the DVD. The DVD with low-impact aerobic exercises developed by the researchers in collaboration with a qualified prenatal yoga teacher. The program incorporated modified yoga movements suitable for pregnant women. Women in experimental group were instructed to use the DVD 3 times a week for 3 months. The control group received routine prenatal care only.

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: January 1, 2014
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share