NCT06242106

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

January 28, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Aerobic exercise,FatigueStressGestational diabetesGlycemic controlSelf-stretching

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    8 weeks

Study Arms (2)

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

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

Device: Glucometer

Interventions

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

Aerobic exercises + self-stretchingControl Group (Self stretching)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGestational Diabetes during pregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 -40.
  • Weight: 70kg-100kg.
  • Women diagnosed with gestational diabetes.
  • Second and third trimester of pregnancy

You may not qualify if:

  • Females having history of depression
  • Thyroid problems
  • Preexisting diabetes • Early onset diabetes
  • Multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetes, GestationalFatigue

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Faiza Taufiq, PPDPT

    Riphah International University, Senior Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

March 15, 2023

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations