- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242106
Effects of Self-stretching and Aerobic Exercise in Gestational Diabetes.
Effects of Self-stretching With and Without Aerobic Exercise on Glycemic Control, Fatigue and Stress in Gestational Diabetes
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran amjad, phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Faiza Taufiq, PPDPT
- Phone Number: 03214811399
- Email: faiza.taufiq@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 44000
- Jinnah Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20 -40.
- Weight: 70kg-100kg.
- Women diagnosed with gestational diabetes.
- Second and third trimester of pregnancy
Exclusion Criteria:
- Females having history of depression
- Thyroid problems
- Preexisting diabetes • Early onset diabetes
- Multiple pregnancies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic exercises + self-stretching
• 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
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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
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Active Comparator: Control Group (Self stretching)
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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8 weeks
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Fatigue assessment scale
Time Frame: 8 weeks
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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
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8 weeks
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Perceived stress scale:
Time Frame: 8 weeks
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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
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faiza Taufiq, PPDPT, Riphah International University, Senior Lecturer
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
Other Study ID Numbers
- S22C14G92006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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