NCT07023978

Brief Summary

102 pregnant women will be randomly divided into 2 groups. Participants in the control group will be given pregnancy counseling that includes only nutrition, walking (3 days a week for 30 minutes), and breathing exercises, and will be called for 1st, 2nd and 3rd month check-ups. In addition to pregnancy counseling, the Qigong group will receive 2 Qigong training sessions, one via Zoom and one face-to-face, and then the training videos of each exercise will be sent via WhatsApp. Paricipants will be asked to do the Qigong exercises at home for 30 minutes, 3 days a week for 12 weeks. These participants will be called for 1-month, 2-month and 3-month check-ups. Blood pressure and sugar measurements will be recorded at the first visit, 1st month, 2nd month and 3rd month check-ups, and patients will also be evaluated with the Pregnancy Physical Activity Questionnaire, Pregnancy Stress Assessment Scale, Pregnancy-related Anxiety Scale, Pregnancy Exercise Self-Efficacy Questionnaire. After the recruitment period the results will be evaluated statistically.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

August 7, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 1, 2025

Last Update Submit

August 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Blood Glucose Values

    Glucose is the key metabolic substrate for tissue energy production. In the perinatal period the mother supplies glucose to the fetus and for most of the gestational period the normal lower limit of fetal glucose concentration is around 3 mmol/L. diabetes is high blood sugar (glucose) that develops during pregnancy and usually disappears after giving birth. It can happen at any stage of pregnancy, but is more common in the second or third trimester.

    2 minutes

  • Pregnancy Exercise Self-Efficacy Scale

    The Pregnancy Exercise Self-Efficacy Scale (P-ESES) is a validated tool designed to assess a pregnant woman's confidence in her ability to engage in physical activity during pregnancy. It measures self-efficacy across various situations that may influence exercise behavior, such as fatigue, lack of time, or discomfort. The scale typically includes a set of statements where respondents rate their confidence levels using a Likert-type scale (usually from 1 = not at all confident to 5 = completely confident). Higher total scores indicate greater self-efficacy regarding exercise during pregnancy. The final score is calculated by summing all item responses, and it helps identify women who may need additional support or encouragement to stay active.

    10 minutes

  • blood pressure value

    High blood pressure during pregnancy occurs when a pregnant woman has a blood pressure reading of 140/90 mm Hg or higher in two readings that are 4 or more hours apart. Severe high blood pressure during pregnancy occurs when a pregnant woman has a blood pressure reading of 160/110 mm Hg on two or more occasions

    2 minutes

Secondary Outcomes (2)

  • The 30-item Pregnancy Stress Rating Scale (PSRS)

    10 minutes

  • Pregnancy-related anxiety scale

    10 minutes

Study Arms (2)

control arm

NO INTERVENTION

50 Pregnant women in the control group will be given pregnancy counseling that includes only nutrition, walking (3 days a week for 30 minutes), and breathing exercises, and will be called for 1st, 2nd and 3rd month check-ups.

Qigong arm

ACTIVE COMPARATOR

In addition to pregnancy counseling, the Qigong group will receive (52 participants) 2 Qigong training sessions, one via Zoom and one face-to-face, and then the training videos of each exercise will be sent via WhatsApp. Patients will be asked to do the Qigong exercises at home for 30 minutes, 3 days a week for 12 weeks. These patients will be called for 1-month, 2-month and 3-month check-ups.

Other: Some movements in the qigong study called Ba Duan Jin, which will be applied to pregnant women, will be arranged for pregnant women and explained in detail. These are very slow, movements

Interventions

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy females will be participate
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women between the ages of 18-40 who have a new pregnancy detected by USG
  • Pregnant women whose pregnancy week is compatible with fetal development, who do not have any problems and who will not have any problems exercising

You may not qualify if:

  • Those with risky pregnancies (cervical dilation, bleeding, premature membrane rupture, etc.) \*\<18 and \>40 years old pregnant women
  • Those with cardiovascular disease or hypertension
  • Those with uncontrolled diabetes
  • Those with uncontrolled thyroid disease
  • Those with a previous risky pregnancy or a complication
  • Those with an operation, metabolic bone disease or joint limitation that will prevent them from exercising
  • Those who are included in another pregnancy counseling or physical activity program
  • Those who do not give their consent for the study, do not come to regular pregnancy check-ups or have incomplete information will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home adress of the principal investigator

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical medicine and rehabilitation specialist

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 17, 2025

Study Start

December 15, 2024

Primary Completion

July 30, 2025

Study Completion

August 5, 2025

Last Updated

August 7, 2025

Record last verified: 2025-06

Locations