Maternal Exercise and Antenatal Anxiety

NCT04624802 | Unknown DMC

• 1 other identifier: 20200601031-FS01
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized controlled trial study. We evaluate effectiveness of maternal exercise on anxiety during normal pregnancy compared to those who receive antenatal care regularly. We plan to recruit 220 healthy pregnant women over the age of 18 in Shenzhen and to use a standard maternal exercise from Korea as intervention.

Conditions

Anxiety

Keywords

anxiety; pregnancy; exercise

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of State Anxiety at 32 Weeks of Gestation

  We use state anxiety subscale of State-Trait Anxiety Inventory (STAI) as the measure of anxiety severity. The STAI comprises two-self report scales for measuring two distinct anxiety concepts, the State anxiety and Trait anxiety. Both scales contain 20 statements that ask the respondent to describe how she feels at a particular moment (state anxiety) or how she generally feels (trait anxiety). State anxiety is conceptualized as a transitory emotional state, where as trait anxiety refers to relatively stable individual differences in proneness to anxiety. The respondents are required to rate themselves on a four point likert scale 'not at all' to 'very much so on' various anxiety related symptoms which they experience in the past weeks for the state scale or how they generally feel for the trait scale. STAI is widely used and has been shown to have high reliability and validity with a Cronbach's alpha of 0.88 and 0.83 for state (STAI-I) and trait anxiety (STAI-II) respectively.

  The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).

Secondary Outcomes (2)

• Change from Baseline of Depressive Symptom at 32 Weeks of Gestation

  The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).

• Change from Baseline of Pain at 32 Weeks of Gestation

  The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).

Study Arms (2)

maternal exercise training group

EXPERIMENTAL

Pregnant women in experimental group are invited to participate in 16 exercise weekly classes for 40 min including 15 min aerobic exercise，10 min relaxation exercise, and 15 min aerobic exercise, from week 16 to week 32 of gestation, and receive antenatal care and examination regularly.

Behavioral: maternal exercise

antenatal care group

NO INTERVENTION

Pregnant women in antenatal care group receive antenatal care and examination regularly.

Interventions

maternal exercise BEHAVIORAL

The maternal exercise is broadly practiced by pregnant women in China. It is designed by a team led by Shen Shanmei, a professor of Maternity Exercises at Department of Obstetrics and Gynecology of First Hospital in Korea.

maternal exercise training group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.

You may not qualify if:

• pregnant women who have accepted maternal exercise training (at least twice a week in last month);2.pregnant women who have orthopedics, cardiovascular or mental diseases; 3.pregnant women who have or had any condition as follows:miscarriage more than two times,premature delivery,placenta previa,fetal dysplasia, low weight before pregnancy (BMI \<17.5),polycyesis,preeclampsia,premature rupture of membranes,Uterine growth retardation,cervical/ligation,repeated vaginal bleeding,anemia or diabetes; 4.the gestational age is less than 12 weeks or more than 16 weeks;5.received psychotherapy or psychotropic medication within 6 months before the study;6.can not participate in regular inspections.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

MeSH Terms

Conditions

Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: November 12, 2020
• Study Start: November 10, 2020
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 12, 2020

Record last verified: 2020-11