Gestational Diabetes Mellitus in PregnancyNCT06480292
Telerehabilitation Exercise: Effects on Maternal Quality of Life, Fetal and Neonatal Health.
A study testing telerehabilitation exercise and routine medical care in people with Gestational Diabetes Mellitus in Pregnancy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Gestational diabetes mellitus (GDM) occurs when blood sugar levels rise during pregnancy, typically between 24-28 weeks, affecting about 2-18% of all pregnancies. It is a common metabolic disease that can lead to health risks for the mother, fetus, and child, and can negatively impact the mother's quality of life. 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
- What is being tested?
- telerehabilitation exercise 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
- 68 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2024to 10 Jun 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 Maternal Quality of Life, Fetal and Neonatal Health Outcomes in Women With Gestational Diabetes Mellitus
Gestational diabetes mellitus (GDM) occurs when blood sugar levels rise during pregnancy, typically between 24-28 weeks, affecting about 2-18% of all pregnancies. It is a common metabolic disease that can lead to health risks for the mother, fetus, and child, and can negatively impact the mother's quality of life. This study aims to explore how a telerehabilitation exercise program affects the quality of life of mothers with GDM and the health of fetus/neonate.
Read the detailed description
Gestational diabetes mellitus (GDM) significantly impacts maternal quality of life (QoL) and fetal/neonatal health. According to the World Health Organization, quality of life (QOL) is a person's view of their status in life within their culture and value system. Pregnancies with GDM, negatively affect personal, familial, and social life, leading to poorer QOL. GDM causes medical issues for the mother and fetus and harms the mother's psychological well-being, reducing her QOL. Due to the increasing prevalence of GDM and the importance of improving QOL for affected women, this study examines impact of telerehabilitation exercise on quality of life of pregnant women. Awareness about the importance of exercise in managing gestational diabetes mellitus (GDM) is crucial. Regular physical activity can help control blood sugar levels, reduce insulin resistance, and improve overall health for both the mother and fetus leading to better pregnancy outcomes.Telerehabilitation offers convenience, accessibility, and personalized support, allowing patients to exercise from home with continuous healthcare provider monitoring.It is a cost-effective, flexible, and safer alternative to traditional exercise methods, especially beneficial for managing gestational diabetes.
The control group will recieve routine medical care and the experimental group will recieve 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 their quality of life.
- Being tested
- telerehabilitation exercise, routine medical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitation exerciseOther
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 program | 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. along with routine medical care will be provided. Receives: Other: telerehabilitation exercise |
| Routine medical care | Active comparator | The control group will receive routine medical care including oral medication (metformin), dietry precautions and advised to do regular walk for 20-30minutes. Receives: Other: routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
GDMQ-36 for Maternal Quality of Life
The GDMQ (Gestational Diabetes Mellitus Quality of Life)-36 is a simple, valid, and reliable tool for assessing the quality of life of women with GDM across five domains: Emotional, Physical, Social, Self-Efficacy, and Healthcare. Each domain includes multiple items rated on a 5-point Likert scale (strongly agree to strongly disagree) with a score range of 1 to 5. Domain scores are calculated by summing the responses for each item, and the total GDMQ score is the sum of all domain scores. Higher scores generally indicate better quality of life if the scale is positively oriented. This tool helps identify areas needing intervention and support, offering a comprehensive measure of GDM-related quality of life.
Measured: changes from baseline to 8th week
Secondary outcomes (2)
Fetal Health
Fetal Health measured by fetal obstetric ultrasound and anomaly scan.
Measured: changes from baseline to 8th week
Neonatal Health
Neonatal outcome measured by examination and pediatric records.
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 posted28 Jun 2024
- Study start1 Jul 2024
- Primary completion10 Jun 2025
- Study completion10 Jun 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
- This will be a comparison between two groups; experimental and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 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
- NCT06480292
- Sponsor's protocol ID
- Ghazal Fatima
- 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 Maternal Quality of Life, Fetal and Neonatal Health Outcomes in Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06480292
- Acronym / sponsor ID
- Ghazal Fatima
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 28 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 mellitus (GDM) occurs when blood sugar levels rise during pregnancy, typically between 24-28 weeks, affecting about 2-18% of all pregnancies. It is a common metabolic disease that can lead to health risks for the mother, fetus, and child, and can negatively impact the mother's quality of life. This study aims to explore how a telerehabilitation exercise program affects the quality of life of mothers with GDM and the health of fetus/neonate.
Detailed description
Gestational diabetes mellitus (GDM) significantly impacts maternal quality of life (QoL) and fetal/neonatal health. According to the World Health Organization, quality of life (QOL) is a person's view of their status in life within their culture and value system. Pregnancies with GDM, negatively affect personal, familial, and social life, leading to poorer QOL. GDM causes medical issues for the mother and fetus and harms the mother's psychological well-being, reducing her QOL. Due to the increasing prevalence of GDM and the importance of improving QOL for affected women, this study examines impact of telerehabilitation exercise on quality of life of pregnant women. Awareness about the importance of exercise in managing gestational diabetes mellitus (GDM) is crucial. Regular physical activity can help control blood sugar levels, reduce insulin resistance, and improve overall health for both the mother and fetus leading to better pregnancy outcomes.Telerehabilitation offers convenience, accessibility, and personalized support, allowing patients to exercise from home with continuous healthcare provider monitoring.It is a cost-effective, flexible, and safer alternative to traditional exercise methods, especially beneficial for managing gestational diabetes.
The control group will recieve routine medical care and the experimental group will recieve 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 their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a comparison between two groups; experimental and control group.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation exercise program | Experimental | Other: telerehabilitation exerciseThis 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. along with routine medical care will be provided. |
| Routine medical care | Active comparator | Other: routine medical careThe control group will receive routine medical care including oral medication (metformin), dietry precautions and advised to do regular walk for 20-30minutes. |
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 exercise5 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 program |
| 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
GDMQ-36 for Maternal Quality of Life
Time frame: changes from baseline to 8th week
The GDMQ (Gestational Diabetes Mellitus Quality of Life)-36 is a simple, valid, and reliable tool for assessing the quality of life of women with GDM across five domains: Emotional, Physical, Social, Self-Efficacy, and Healthcare. Each domain includes multiple items rated on a 5-point Likert scale (strongly agree to strongly disagree) with a score range of 1 to 5. Domain scores are calculated by summing the responses for each item, and the total GDMQ score is the sum of all domain scores. Higher scores generally indicate better quality of life if the scale is positively oriented. This tool helps identify areas needing intervention and support, offering a comprehensive measure of GDM-related quality of life.
2 secondary outcomes
Fetal Health
Time frame: changes from baseline to 8th week
Neonatal Health
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 and routine medical care in people with Gestational Diabetes Mellitus in Pregnancy, 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?
GDMQ-36 for Maternal Quality of Life (time frame: changes from baseline to 8th week). 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.