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Effects of Aerobic Exercise in Pregnant WomenNCT04364919

Aerobic Exercise on Prenatal Sleep Quality and Maternal-fetal Attachment

A study testing aerobic exercise program in people with Effects of Aerobic Exercise in Pregnant Women, run by National Cheng-Kung University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 23 to 43 years, women only
What is being tested?
aerobic exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
1 Jan 2014to 31 Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • The inclusion criteria were (a) uncomplicated pregnancy, (b) between 16 and 30 weeks gestation, and (c) informed consent to participate.

Who cannot join

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

About this study

Official title: Effects of Aerobic Exercise on Sleep Quality and Maternal-fetal Attachment in Pregnant Women: A Randomized Controlled Pilot Study

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.

Read the detailed description

3.1 | Study design In this study, a single-blinded, randomized, controlled trial with a prospective pretest-posttest experimental design was implemented to examine the effects of low-impact aerobic exercise with modified yoga movements on sleep quality and maternal-fetal attachment in pregnant women.

3.2 | Participants Participants for this study were recruited from the prenatal clinic of a medical center in southern Taiwan. A sample size of 63 per group was considered sufficient to estimate a medium effect of .50 with α-value of 0.05 and a power of 0.08 (Polit \& Beck, 2011). Considering a 20% attrition rate over 3 months, 140 pregnant women were enrolled.

3.3 | Intervention The intervention group received a 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. 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). The yoga teacher instructed the participants to touch their heart with their right hand and their abdomen with their left hand, feeling a connection with the fetus in the warm-up and in the final breath-regulating stage of exercise (2 minutes). An expert video producer edited the DVD for sound, animation, and subtitles. The exercise program requires twenty minutes to complete. Women were instructed to use the DVD 3 times a week for 3 months. The DVD was reviewed for content validity by two clinical obstetric nursing experts, and in addition, two pregnant women in their second trimester reviewed the DVD for face validity.

3.5 | Procedure and ethical considerations The present study was carried out from January to October 2014 after approval was obtained from the institutional review board of the participating institution. 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.

In addition to routine care, the experimental group was given the DVD and instructed to engage in the aerobic exercise program shown on the DVD. The control group received routine prenatal care only. The two groups were asked to complete the demographic data form, the MMFAS, and the PSQI at 3 time periods: before the intervention, at 4 weeks, and 12 weeks post-intervention. All participants in both groups received a small gift after completing the pretests. The latter two sets of questionnaires were mailed with postage-paid, pre-addressed envelopes to all of the participants for them to complete and return. Sixty-one participants in the experimental group and 62 participants in the control group completed the 1-month posttests; 51 participants in the experimental group and 47 participants in control group completed the 3-month posttests. The CONSORT diagram of this study is shown in Figure 1. The experimental group participants were asked to complete an open-ended question on the subjective benefits of practicing aerobic exercise.

3.6 | Data analysis Tests for differences in baseline characteristics between the two groups included the χ2 test for categorical variables and the t-test for continuous variables. The effectiveness of yoga-based low-impact aerobic exercise on maternal-infant attachment and sleep quality was determined by a paired t-test. All results with p < .05 were considered statistically significant. The SPSS (version 17.0 for Windows, SPSS Inc., Chicago, IL, USA) statistical software package was used to analyze the data.

Being tested
aerobic exercise program
Keywords
aerobic exercise, prenatal care, sleep quality, maternal-fetal attachment
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aerobic exercise programBehavioural

    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).

Study groups in NCT04364919
Study groupRoleWhat they receive
aerobic exercise interventionExperimentalThe 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.
Receives: Behavioral: aerobic exercise program
control groupNo interventionThe control group received routine prenatal care only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start1 Jan 2014
  3. Primary completion31 Oct 2014
  4. Study completion31 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364919
Sponsor's protocol ID
NSC102-2314-B006-063-MY2
Status last verified
Apr 2020
First submitted
24 Apr 2020
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing aerobic exercise program in people with Effects of Aerobic Exercise in Pregnant Women, run by National Cheng-Kung University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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