Sleep DeprivationCESPNCT07367360
A Comparative Analysis of Stretching Exercise and Pregnancy Exercise on Sleep Quality in Pregnancy: A Quasi Experiment
A study testing Traditional Pregnancy Exercise Group in people with Sleep Deprivation and Sleep Wake Disorders, run by Health Polytechnic of Palangka Raya at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Wake Disorders, Pregnancy
- What is being tested?
- Traditional Pregnancy Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Aug 2025to 4 Nov 2025
- 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 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sleep Deprivation, Sleep Wake Disorders, Pregnancy, Anxiety Disorders, Stretching Exercises, Relaxation Therapy
- Being tested
- Traditional Pregnancy Exercise Group, Stretching Exercise Group (Control)
- Keywords
- Pregnancy, Sleep Deprivation, Anxiety, Stretching Exercises, Exercise Therapy
- Medical subject headings
- Sleep Deprivation, Sleep Wake Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Pregnancy Exercise GroupOther
Also called Traditional Pregnancy Exercise
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.
Stretching Exercise Group (Control)Other
Also called Stretching Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Traditional Pregnancy Exercise Group; Other: 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. Receives: Other: Traditional Pregnancy Exercise Group; Other: Stretching Exercise Group (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment and baseline measurement to completion of the 3-week exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start4 Aug 2025
- Primary completion4 Oct 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Polytechnic of Palangka Raya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vissia Didin Ardiyani, Dr, Study chair, Health Polytechnic of Palangka Raya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367360
- Sponsor's protocol ID
- 121/II/KE.PE/2024
- Other IDs
- 121/II/KE.PE/2024
- Acronym
- CESP
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Stretching Exercise and Pregnancy Exercise on Sleep Quality in Pregnancy: A Quasi Experiment
- ClinicalTrials.gov ID
- NCT07367360
- Acronym / sponsor ID
- CESP / 121/II/KE.PE/2024
- Conditions
- Sleep Deprivation, Sleep Wake Disorders, Pregnancy, Anxiety Disorders, Stretching Exercises, Relaxation Therapy
- Keywords
- Pregnancy, Sleep Deprivation, Anxiety, Stretching Exercises, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Health Polytechnic of Palangka RayaUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Traditional Pregnancy Exercise Group, Other: Stretching Exercise Group (Control)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. |
| Control group | Experimental | Other: Traditional Pregnancy Exercise Group, Other: Stretching Exercise Group (Control)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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Pregnancy Exercise GroupAlso: Traditional Pregnancy ExerciseA 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 | Control group, Intervention Group |
| Stretching Exercise Group (Control)Also: Stretching ExerciseA 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 | Control group, Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Sleep Deprivation
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
ICU, Sleep Deprivation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vissia Didin Ardiyani, Dr study chair
Health Polytechnic of Palangka Raya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Pregnancy Exercise Group in people with Sleep Deprivation and Sleep Wake Disorders, run by Health Polytechnic of Palangka Raya at 1 site in Indonesia.
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 7 inclusion and 8 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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). 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 27 Jan 2026.