NCT07367360

Brief Summary

The goal of this clinical trial is to learn whether pregnancy exercise or stretching exercise can improve sleep quality in third trimester pregnant women who experience sleep disturbances. The main questions it aims to answer are:

  • Does traditional pregnancy exercise improve sleep quality more effectively than stretching exercise?
  • Does either type of exercise reduce anxiety levels that may affect sleep? Researchers will compare a pregnancy exercise group with a stretching exercise group to see whether one approach leads to better sleep quality. Participants will:
  • Attend guided exercise sessions twice a week for three weeks
  • Complete questionnaires about sleep quality, anxiety, and physical activity
  • Have basic health measurements taken (blood pressure, weight, height) before and after the program This study hopes to show whether moderate exercise can help pregnant women sleep better during the third trimester.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 17, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

PregnancySleep DeprivationAnxietyStretching ExercisesExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), measured at baseline and after the 3-week intervention period

    Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates sleep patterns over the previous one-month period. The PSQI consists of 19 self-rated items\*\* that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, and the scores are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is commonly used to define poor sleep quality. Participants complete the PSQI at baseline and again after the three-week intervention period to determine changes in sleep quality associated with the exercise programs.

    From enrollment and baseline measurement to completion of the 3-week exercise program

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this arm take part in a structured traditional pregnancy exercise program designed specifically for women in the third trimester. The program follows guidelines from the Indonesian Ministry of Health and includes gentle movements, breathing techniques, posture training, pelvic floor exercises, and relaxation components intended to support comfort and well-being during late pregnancy. Sessions are conducted twice per week for three weeks, with each session lasting approximately 45-60 minutes and led by trained midwives or instructors at the participating clinic. Participants also receive printed and video materials to support safe practice at home. The intervention aims to improve sleep quality, reduce physical discomfort, and promote relaxation.

Other: Traditional Pregnancy Exercise GroupOther: Stretching Exercise Group (Control)

Control group

EXPERIMENTAL

Participants in the control group take part in a stretching exercise program designed to promote flexibility, reduce muscle tension, and support overall comfort during late pregnancy. The program consists of gentle, low-intensity stretching movements that target major muscle groups commonly affected during the third trimester, such as the back, hips, legs, and shoulders. Sessions are conducted twice per week for three weeks, with each session lasting approximately 45-60 minutes and guided by trained clinic staff. The stretching routine is simple, safe, and suitable for pregnant women, and participants receive printed and video materials to help them practise at home. This intervention serves as a comparison condition to evaluate whether traditional pregnancy exercise offers additional benefits for sleep quality and anxiety beyond those provided by basic stretching.

Other: Traditional Pregnancy Exercise GroupOther: Stretching Exercise Group (Control)

Interventions

A structured exercise program for third-trimester pregnant women, following the Indonesian Ministry of Health guidelines. Includes breathing techniques, gentle movements, posture training, pelvic floor exercises, and relaxation. Conducted twice weekly for 3 weeks, 45-60 minutes per session, led by trained clinic staff.

Also known as: Traditional Pregnancy Exercise
Control groupIntervention Group

A low-intensity stretching routine targeting major muscle groups to reduce tension and support comfort during late pregnancy. Conducted twice weekly for 3 weeks, 45-60 minutes per session, guided by trained clinic staff.

Also known as: Stretching Exercise
Control groupIntervention Group

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is open only to women who are currently pregnant. Because the research focuses on sleep quality and exercise during the third trimester of pregnancy, only individuals who identify as female and are carrying a pregnancy can take part. People who are not pregnant or who are not biologically able to become pregnant are not eligible for this study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women in their third trimester (28-30 weeks of gestation at enrollment).
  • Having sleeping disturbance complaints.
  • Aged more than 19 years old.
  • Being under prenatal clinical follow-up
  • Not having or participating in specific treatment for sleeping disturbance in the last 3 months
  • Able to participate in light to moderate physical activity as assessed by clinic staff.
  • Signing informed consent for study participation.

You may not qualify if:

  • Failure to attend at least 70% of the 12 planned sessions
  • Having pregnancy complication.
  • Gestational ages \< 28 or \> 30 weeks.
  • Not having bleeding history, abortion.
  • Not having multiple pregnancy.
  • Medical or obstetric conditions that make exercise unsafe (e.g., preeclampsia, placenta previa, risk of preterm labor, uncontrolled hypertension)
  • Current participation in another structured exercise program.
  • Severe musculoskeletal problems that limit movement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwifery clinics

Palangkaraya, Central Kalimantan, 73111, Indonesia

Location

MeSH Terms

Conditions

Sleep DeprivationSleep Wake DisordersAnxiety Disorders

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

DyssomniasNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vissia Didin Ardiyani, Dr

    Health Polytechnic of Palangka Raya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment model with each group receiving a distinct exercise intervention. Clinics use their own staff and routines, creating natural variation in session delivery. Both groups follow structured exercise programs for pregnant women in the third trimester: Intervention Group: Traditional pregnancy exercises per Indonesian Ministry of Health guidelines. Control Group: Stretching focused on flexibility and relaxation. Participants complete two supervised sessions weekly for three weeks (45-60 minutes/session) and receive home practice materials. Sleep quality, anxiety, physical activity, and health indicators are measured before and after to compare changes. The design enables researchers to assess the impact of two exercise approaches on sleep quality, accounting for individual differences.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

August 4, 2025

Primary Completion

October 4, 2025

Study Completion

November 4, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the dataset contains sensitive health information from pregnant women, and sharing it could compromise participant privacy and confidentiality. Additionally, the study was not designed with data-sharing agreements or infrastructure in place to support secure external access.

Locations