Gestational DiabetesNCT06242106
Effects of Self-stretching and Aerobic Exercise in Gestational Diabetes.
A study testing Glucometer in people with Gestational Diabetes, run by Riphah International University at 1 site in Pakistan.
Trial summary
: Gestational diabetes is a common pregnancy-related condition characterized by impaired glucose metabolism. It poses risks to both maternal and fetal health. Physical activity interventions, such as self-stretching and aerobic exercise, have shown potential in improving glycemic control and managing associated… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Glucometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Feb 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 -40.
- Weight: 70kg-100kg.
- Women diagnosed with gestational diabetes.
- Second and third trimester of pregnancy
Who cannot join
- Females having history of depression
- Thyroid problems
- Preexisting diabetes • Early onset diabetes
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Self-stretching With and Without Aerobic Exercise on Glycemic Control, Fatigue and Stress in Gestational Diabetes
: Gestational diabetes is a common pregnancy-related condition characterized by impaired glucose metabolism. It poses risks to both maternal and fetal health. Physical activity interventions, such as self-stretching and aerobic exercise, have shown potential in improving glycemic control and managing associated symptoms in individuals with diabetes. Objective: To determine the effects of self-stretching, with or without aerobic exercise, on glycemic control, fatigue, and stress for women with gestational diabetes
Read the detailed description
A Randomized controlled trial was conducted at khursheed majeed Hospital Lahore and was completed in 8th month after approval of synopsis .A sample of 24 women having age 20 to 40 with gestational diabetes were selected through non probability convenience sampling technique and then randomly allocated into group A(self-stretching with aerobic exercise) and group B (self-stretching without aerobic exercise). The outcome measures were glycemic control, assessed by measuring fasting and postprandial blood glucose levels using a glucometer fatigue and stress levels, measured by Fatigue Assessment Scale (FAS) and Perceived Stress Scale (PSS), respectively. These measures will be obtained at baseline and after the 7-weeks intervention period. All participants in both groups were evaluated before and after the treatment programs.
Data was analyzed by using SPSS 25. Results: Mean value of Fasting blood glucose pre-treatment (Mean Difference=0.05) and post treatment (Mean Difference=0.14) with p value <0.05. Mean value of 2 h postprandial blood glucose pre-treatment (Mean Difference=0.04) and post treatment (Mean Difference=0.20) with p value <0.05.Mean value of Fatigue assessment scale pre-treatment (Mean Difference=1.56) and post treatment (Mean Difference=4.21) with p value <0.05. Mean value of Perceived stress scale pre-treatment (Mean Difference=1.05) and post treatment (Mean Difference=4.74) with p value <0.05 Conclusion: The study concluded that both groups Aerobic exercises + self-stretching (experimental group) and self-stretching Exercises only (control group) improve glycemic control, reduce fatigue and stress in gestational diabetes. However Aerobic exercises + self-stretching is more effective than self-stretching only
- Conditions
- Gestational Diabetes
- Being tested
- Glucometer
- Keywords
- Aerobic exercise,, Fatigue, Stress, Gestational diabetes, Glycemic control, Self-stretching
- Medical subject headings
- Diabetes, Gestational, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucometerDevice
A glucometer, which is a portable device used to measure blood glucose levels, was used in this study to collect data. It is a dependable and widely used tool for assessing glycemic control in people with diabetes, including gestational diabetes
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercises + self-stretching | Experimental | • After the baseline assessment, the patient in the experimental group received self-stretching with aerobic exercises. Self-stretching that includes butterfly stretch, wall stretching and cat and cow pose for 5 sec each and 10 repetitions, with aerobic exercises that includes 30 minutes (2 sets each is of 15 minutes) of treadmill, Static cycling for 15 minutes and walking for straight 20 minutes. For 7 weeks Receives: Device: Glucometer |
| Control Group (Self stretching) | Active comparator | After the baseline assessment, the patient in the control group received self-stretching without aerobic exercises. Self-stretching that includes butterfly stretch, wall stretching and cat and cow pose for 5 sec each and 10 repetitions for 7 weeks Receives: Device: Glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucometer
A glucometer, which is a portable device used to measure blood glucose levels, was used in this study to collect data. It is a dependable and widely used tool for assessing glycemic control in people with diabetes, including gestational diabetes. These measurements provided factual information on glycemic control and help compare blood glucose levels between the self-stretching with and without aerobic exercise groups
Measured: 8 weeks
Fatigue assessment scale
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale evaluates all aspects of fatigue, it measures both physical and mental symptoms. This scale can be useful in tracking fatigue over time in the context of psychiatric conditions, physical illness or chronic fatigue syndrome. The FAS has an internal consistency of .90. Results on the scale also correlated highly with the fatigue-related subscales of other measures like the Checklist Individual Strength. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. A description of the fatigue experienced is presented for the total score where: less than 22 indicates "normal" (i.e. healthy) levels of fatigue, between 22 and 34 indicates mild-to-moderate fatigue and 35 or more indicates severe fatigue
Measured: 8 weeks
Perceived stress scale:
The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The tool, while originally developed in 1983, remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. The Perceived Stress Scale is interesting and important because your perception of what is happening in your life is most important
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Mar 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PPDPT, Principal investigator, Riphah International University, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242106
- Sponsor's protocol ID
- S22C14G92006
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-stretching With and Without Aerobic Exercise on Glycemic Control, Fatigue and Stress in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06242106
- Acronym / sponsor ID
- S22C14G92006
- Conditions
- Gestational Diabetes
- Keywords
- Aerobic exercise,, Fatigue, Stress, Gestational diabetes, Glycemic control, Self-stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 5 Feb 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 is a common pregnancy-related condition characterized by impaired glucose metabolism. It poses risks to both maternal and fetal health. Physical activity interventions, such as self-stretching and aerobic exercise, have shown potential in improving glycemic control and managing associated symptoms in individuals with diabetes. Objective: To determine the effects of self-stretching, with or without aerobic exercise, on glycemic control, fatigue, and stress for women with gestational diabetes
Detailed description
A Randomized controlled trial was conducted at khursheed majeed Hospital Lahore and was completed in 8th month after approval of synopsis .A sample of 24 women having age 20 to 40 with gestational diabetes were selected through non probability convenience sampling technique and then randomly allocated into group A(self-stretching with aerobic exercise) and group B (self-stretching without aerobic exercise). The outcome measures were glycemic control, assessed by measuring fasting and postprandial blood glucose levels using a glucometer fatigue and stress levels, measured by Fatigue Assessment Scale (FAS) and Perceived Stress Scale (PSS), respectively. These measures will be obtained at baseline and after the 7-weeks intervention period. All participants in both groups were evaluated before and after the treatment programs.
Data was analyzed by using SPSS 25. Results: Mean value of Fasting blood glucose pre-treatment (Mean Difference=0.05) and post treatment (Mean Difference=0.14) with p value <0.05. Mean value of 2 h postprandial blood glucose pre-treatment (Mean Difference=0.04) and post treatment (Mean Difference=0.20) with p value <0.05.Mean value of Fatigue assessment scale pre-treatment (Mean Difference=1.56) and post treatment (Mean Difference=4.21) with p value <0.05. Mean value of Perceived stress scale pre-treatment (Mean Difference=1.05) and post treatment (Mean Difference=4.74) with p value <0.05 Conclusion: The study concluded that both groups Aerobic exercises + self-stretching (experimental group) and self-stretching Exercises only (control group) improve glycemic control, reduce fatigue and stress in gestational diabetes. However Aerobic exercises + self-stretching is more effective than self-stretching only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises + self-stretching | Experimental | Device: Glucometer• After the baseline assessment, the patient in the experimental group received self-stretching with aerobic exercises. Self-stretching that includes butterfly stretch, wall stretching and cat and cow pose for 5 sec each and 10 repetitions, with aerobic exercises that includes 30 minutes (2 sets each is of 15 minutes) of treadmill, Static cycling for 15 minutes and walking for straight 20 minutes. For 7 weeks |
| Control Group (Self stretching) | Active comparator | Device: GlucometerAfter the baseline assessment, the patient in the control group received self-stretching without aerobic exercises. Self-stretching that includes butterfly stretch, wall stretching and cat and cow pose for 5 sec each and 10 repetitions for 7 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 -40.
- Weight: 70kg-100kg.
- Women diagnosed with gestational diabetes.
- Second and third trimester of pregnancy
Key exclusion criteria (4 listed)
- Females having history of depression
- Thyroid problems
- Preexisting diabetes • Early onset diabetes
- Multiple pregnancies
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 |
|---|---|---|
| GlucometerA glucometer, which is a portable device used to measure blood glucose levels, was used in this study to collect data. It is a dependable and widely used tool for assessing glycemic control in people with diabetes, including gestational diabetes | Device | Aerobic exercises + self-stretching, Control Group (Self stretching) |
Primary outcome
Glucometer
Time frame: 8 weeks
A glucometer, which is a portable device used to measure blood glucose levels, was used in this study to collect data. It is a dependable and widely used tool for assessing glycemic control in people with diabetes, including gestational diabetes. These measurements provided factual information on glycemic control and help compare blood glucose levels between the self-stretching with and without aerobic exercise groups
Fatigue assessment scale
Time frame: 8 weeks
The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale evaluates all aspects of fatigue, it measures both physical and mental symptoms. This scale can be useful in tracking fatigue over time in the context of psychiatric conditions, physical illness or chronic fatigue syndrome. The FAS has an internal consistency of .90. Results on the scale also correlated highly with the fatigue-related subscales of other measures like the Checklist Individual Strength. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. A description of the fatigue experienced is presented for the total score where: less than 22 indicates "normal" (i.e. healthy) levels of fatigue, between 22 and 34 indicates mild-to-moderate fatigue and 35 or more indicates severe fatigue
Perceived stress scale:
Time frame: 8 weeks
The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The tool, while originally developed in 1983, remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. The Perceived Stress Scale is interesting and important because your perception of what is happening in your life is most important
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 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
Faiza Taufiq, PPDPT principal investigator
Riphah International University, Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucometer in people with Gestational Diabetes, run by Riphah International University at 1 site 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 4 inclusion and 4 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 19 Apr 2024. 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 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?
Glucometer (time frame: 8 weeks). The study lists 3 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 19 Apr 2024.