- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367360
A Comparative Analysis of Stretching Exercise and Pregnancy Exercise on Sleep Quality in Pregnancy: A Quasi Experiment (CESP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sleep problems are very common during pregnancy, especially in the third trimester, when physical discomfort, hormonal changes, and anxiety often make it difficult for women to rest well. Poor sleep can affect a mother's physical and emotional health, contribute to stress and fatigue, and may even influence labour and delivery outcomes. Although exercise is widely recommended during pregnancy, there is still limited research on which types of exercise are most helpful for improving sleep.
This study aims to better understand whether traditional pregnancy exercise or stretching exercise can help improve sleep quality among third trimester pregnant women living in Palangka Raya, Central Kalimantan. Both types of exercise are commonly used in Indonesia, but their specific effects on sleep have not been directly compared in a structured research setting.
A total of 60 pregnant women between 28 and 30 weeks of gestation will take part in the study. Participants are divided into two groups based on the midwifery clinic where they receive care. One group will participate in traditional pregnancy exercise, a structured program developed by the Indonesian Ministry of Health that includes breathing techniques, gentle movements, and relaxation. The other group will take part in a stretching exercise program, which focuses on improving flexibility and reducing muscle tension.
Both programs run for three weeks, with two supervised sessions per week, each lasting about 45-60 minutes. Participants also receive a booklet and video materials so they can practise at home.
To understand how these exercises affect sleep, participants complete several assessments before and after the program:
- Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality
- Hamilton Anxiety Rating Scale (HARS) to assess anxiety levels
- International Physical Activity Questionnaire (IPAQ) to evaluate overall physical activity
- Basic health measurements such as blood pressure, weight, and height
By comparing the results from both groups, the study will explore whether one type of exercise leads to greater improvements in sleep quality or anxiety. The findings may help midwives, health workers, and pregnant women choose effective, safe, and accessible exercise options to support better sleep during late pregnancy.
The goal of this research is to promote healthier pregnancies by finding easy, non-medicinal ways to help expectant mothers sleep better and enhance their overall well-being.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Central Kalimantan
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Palangkaraya, Central Kalimantan, Indonesia, 73111
- Midwifery clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
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.
Other Names:
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.
Other Names:
|
|
Experimental: Control group
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), measured at baseline and after the 3-week intervention period
Time Frame: From enrollment and baseline measurement to completion of the 3-week exercise program
|
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.
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From enrollment and baseline measurement to completion of the 3-week exercise program
|
Collaborators and Investigators
Investigators
- Study Chair: Vissia Didin Ardiyani, Dr, Health Polytechnic of Palangka Raya
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Anxiety Disorders
- Sleep Wake Disorders
- Sleep Deprivation
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Muscle Stretching Exercises
Other Study ID Numbers
- 121/II/KE.PE/2024 (Other Grant/Funding Number: Health Polytechnic of Palangka Raya)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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