Gestational Diabetes Mellitus in PregnancyNCT06476730
Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes
A study testing Telerehabilitation exercise program and Routine medical care in people with Gestational Diabetes Mellitus in Pregnancy and Gestational Diabetes, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Gestational Diabetes, Maternal Psychological Distress
- What is being tested?
- Telerehabilitation exercise program and Routine medical care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2024to 10 May 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20 to 35 years
- Gestational age between 20-28weeks
- diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
- Primigravida and multigravida
- able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
- Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
- Who signed informed consent
Who cannot join
- Previously diagnosed T1DM or T2DM
- High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
- Patients taking insulin regularly.
- Patients with fetal anomalies diagnosed at 20 th week.
- Multiple gestation (twin or triplets).
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Pakistan Railways Hospital
Rawalpindi, Punjab Province, 44000
AlKhidmat Razi Hospital,Rawalpindi
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Telerehabilitation Exercise Program on Psychological Health and Delivery Outcomes in Women With Gestational Diabetes Mellitus.
Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Women with gestational diabetes often feel more anxious and stressed and have a higher risk of depression during and after pregnancy. This study will explore how telerehabilitation can reduce anxiety and depression and show how exercise can improve the health of pregnant women with gestational diabetes.
Read the detailed description
The diagnosis of GDM can be unexpected and distressing, leading to feelings of sadness and hopelessness.Women with GDM are at a higher risk of experiencing prenatal and postnatal depression, which can affect their overall well-being and ability to care for their newborn. Regularly checking blood sugar levels, changing diet, and possibly using medication or insulin can be overwhelming. This constant effort and worry about complications can cause a lot of anxiety and stress. Many pregnant women with GDM might not fully understand how exercise can help control their blood sugar levels and improve their overall well-being. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve psychological symptoms in participants with GDM.
The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving psychological health.
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Gestational Diabetes, Maternal Psychological Distress
- Being tested
- Telerehabilitation exercise program, Routine medical care
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation exercise programOther
5 min warmup will include ankle plantar and dorsiflexion ,trunk side flexion ,shoulder circles ,shoulder ROMS.it will be followed by 5 min aerobics that includes spot marching and side stepping. it will be followed by resistance exercise which will be divided into 3 groups. each group of exercise will be performed one day each. chair squats, arm pulls, seated triceps, biceps curls etc. are included in these resistance exercises. intensity of each exercise will be progressively increased
Routine medical careOther
The control group will be given routine medical care (including dietary modification, oral anti diabetics (metformin) and advised to do regular walk (20-30min/day).
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation exercise group | Experimental | This group will receive a structured tele rehabilitation exercise protocol (of low to moderate intensity warm up ,aerobic ,resistance and cool down exercises for 3 times a week progressively increased for 8 weeks) in addition to routine medical care for GDM. Receives: Other: Telerehabilitation exercise program |
| Routine medical care | Active comparator | The control group will receive routine medical care including oral medication, diet and regular walk. Receives: Other: Routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Epidemiologic studies depression scale (CES-D)
The CES-DC is an inventory of 20 self-report items regarding depressive symptoms, taking about 5 minutes to completeIn scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Measured: changes from baseline to 8th week
Strait trait anxiety inventory (STAI)
It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale.The total score ranges from 0-63.The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
Measured: changes from baseline to 8th week
Secondary outcomes (4)
Time of delivery
Maternal delivery time in weeks will be noted.
Measured: At the time of delivery
Mode of delivery
Mode of delivery either vaginal or c-section will be noted.
Measured: At the time of delivery
Incidence of instrumental delivery
The incidence of instrumental delivery will be noted wither yes or no.
Measured: At the time of delivery
Incidence of shoulder dystocia
The incidence of shoulder dystocia will be noted wither yes or no.
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jul 2024
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups, experimental and control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PhD, Principal investigator, Riphah International University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476730
- Sponsor's protocol ID
- Muzna Haq
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Telerehabilitation Exercise Program on Psychological Health and Delivery Outcomes in Women With Gestational Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06476730
- Acronym / sponsor ID
- Muzna Haq
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Gestational Diabetes, Maternal Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 26 Jun 2024 (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.
Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Women with gestational diabetes often feel more anxious and stressed and have a higher risk of depression during and after pregnancy. This study will explore how telerehabilitation can reduce anxiety and depression and show how exercise can improve the health of pregnant women with gestational diabetes.
Detailed description
The diagnosis of GDM can be unexpected and distressing, leading to feelings of sadness and hopelessness.Women with GDM are at a higher risk of experiencing prenatal and postnatal depression, which can affect their overall well-being and ability to care for their newborn. Regularly checking blood sugar levels, changing diet, and possibly using medication or insulin can be overwhelming. This constant effort and worry about complications can cause a lot of anxiety and stress. Many pregnant women with GDM might not fully understand how exercise can help control their blood sugar levels and improve their overall well-being. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve psychological symptoms in participants with GDM.
The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving psychological health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups, experimental and control
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation exercise group | Experimental | Other: Telerehabilitation exercise programThis group will receive a structured tele rehabilitation exercise protocol (of low to moderate intensity warm up ,aerobic ,resistance and cool down exercises for 3 times a week progressively increased for 8 weeks) in addition to routine medical care for GDM. |
| Routine medical care | Active comparator | Other: Routine medical careThe control group will receive routine medical care including oral medication, diet and regular walk. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged 20 to 35 years
- Gestational age between 20-28weeks
- diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
- Primigravida and multigravida
- able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
Key exclusion criteria (5 listed)
- Previously diagnosed T1DM or T2DM
- High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
- Patients taking insulin regularly.
- Patients with fetal anomalies diagnosed at 20 th week.
- Multiple gestation (twin or triplets).
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 |
|---|---|---|
| Telerehabilitation exercise program5 min warmup will include ankle plantar and dorsiflexion ,trunk side flexion ,shoulder circles ,shoulder ROMS.it will be followed by 5 min aerobics that includes spot marching and side stepping. it will be followed by resistance exercise which will be divided into 3 groups. each group of exercise will be performed one day each. chair squats, arm pulls, seated triceps, biceps curls etc. are included in these resistance exercises. intensity of each exercise will be progressively increased | Other | Telerehabilitation exercise group |
| Routine medical careThe control group will be given routine medical care (including dietary modification, oral anti diabetics (metformin) and advised to do regular walk (20-30min/day). | Other | Routine medical care |
Primary outcome
Center of Epidemiologic studies depression scale (CES-D)
Time frame: changes from baseline to 8th week
The CES-DC is an inventory of 20 self-report items regarding depressive symptoms, taking about 5 minutes to completeIn scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Strait trait anxiety inventory (STAI)
Time frame: changes from baseline to 8th week
It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale.The total score ranges from 0-63.The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
4 secondary outcomes
Time of delivery
Time frame: At the time of delivery
Mode of delivery
Time frame: At the time of delivery
Incidence of instrumental delivery
Time frame: At the time of delivery
Incidence of shoulder dystocia
Time frame: At the time of delivery
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 12 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Huma Riaz, PhD principal investigator
Riphah International University, Islamabad, Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation exercise program and Routine medical care in people with Gestational Diabetes Mellitus in Pregnancy and Gestational Diabetes, run by Riphah International University at 2 sites in Pakistan.
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 5 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Center of Epidemiologic studies depression scale (CES-D) (time frame: changes from baseline to 8th week). The study lists 2 primary outcomes in all. 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 12 Jun 2025.