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NCT Number: NCT06242106

Effects of Self-stretching and Aerobic Exercise 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

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Fatigue Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucometer

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Self-stretching With and Without Aerobic Exercise on Glycemic Control, Fatigue and Stress in Gestational Diabetes

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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