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Effects of Structured Exercise Regime in Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Structured Exercise for Experimental (Structured Exercise) Group
Control treatment for both groups
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring exercise, pregnancy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women with age of 20 to 40 years and gestational age more than 20 weeks.
  2. Diagnosed Gestational diabetes mellitus patients
  3. Must be able to do 6 min walk test and lie under severity level 6 on the 0-10 Borg scale of breathlessness -

Exclusion Criteria:

1. Diagnosed neurological and cardiopulmonary problems.

-

Sites / Locations

  • Foundation University Islamabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured Exercise Group

Control Group

Arm Description

Structured Exercise Group will receive medical and dietary interventions like insulin plus structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min The combination of Stabilization exercise (10 repetitions) and PFM training ( 20 repetitions set). Relaxation therapy including Mitchells physiological relaxation technique (10 repeatitions) alongwith deep breathing exercises. Life style modification with postural guidance and back care would also be followed. Exercise dosage would be twice a week for 05 weeks while exercise duration will be 45 to 50 min session under Physio supervision and home plan of 10 min exercise daily. Total 150 min per week. Data will be recorded at baseline then after treatment of 5 weeks.

Control Group will receive no structured exercise regime only the group will be receiving medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist due to ethical concerns and their outcomes will be observed at the baseline and then after 05 weeks.

Outcomes

Primary Outcome Measures

HbA1c
HbA1c will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Blood Pressure
Change in the Values of Blood pressure will be assessed at base line and at the end of 5 weeks session.
Lipid profile
Lipid profile will be assessed at the base line and at the end of 5 weeks session
Renal function test (RFT)
RFT will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
C reactive protein
C reactive protein will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Heart rate
Change in the heart rate will be assessed at base line and at the end of 5 weeks session.
Respiratory rate
Change in the respiratory rate will be assessed at base line and at the end of 5 weeks.
Blood glucose level
Change in the blood glucose level will be assessed at base line and at the end of 5 weeks session.

Secondary Outcome Measures

Gestational weight gain
Gestational weight gain by recording weight of women in pounds and gestational age in weeks at baseline and then after 5 weeks.
Edinburgh Post Natal Depression scale (Punjabi version)
The score of Depression using Edinburgh Post Natal Depression scale (Punjabi version). Each answer is given on a score of 0-3 . Maximum score is 30 A score of 10 or higher indicates that depressive symptoms have been

Full Information

First Posted
August 26, 2019
Last Updated
August 28, 2020
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT04146740
Brief Title
Effects of Structured Exercise Regime in Gestational Diabetes Mellitus
Official Title
Effects of Structured Exercise Regime for the Management of Gestational Diabetes Mellitus (GDM) - Bio Psychosocial Perspectives.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Rehabilitation in the field of Obstetrics is an emerging field worldwide although it is still very much neglected in a country like Pakistan. Increasing prevalence of GDM has highlighted the importance of rehabilitation in this specific area. In USA upto14% of pregnancies get GDM problem, 6.8 to 10.4 % in China while in India 27.5% which is exceptionally high. Similarly in Pakistan it has become a common issue. Many observational studies have been done to find the risk factors and causes of GDM. However to the best of investigator's knowledge no experimental study have been done so far on the effects of exercise on physical, physiological and psychological aspects of GDM. Hence a randomized control trial is planned on diagnosed GDM patients in Fauji Foundation Hospital Rawalpindi who will recieve supervised structured exercise regeme for 5 weeks and their data will be recorded using reliable tools at the baseline and after 5 weeks to assess the effects of exercise.
Detailed Description
GDM is a medical condition of high maternal glucose level which is diagnosed only when women are pregnant and overcome after pregnancy. It results in various maternal and neonatal complications like caeserean delivery in mothers and obesity in children. Women having GDM have greater risk of diabetes and cardiovascular problems later in life which is threatening for us. Obese women are at increased risk of developing GDM and it is also a risk factor for developing high blood pressure and protein in the urine after 20 weeks of pregnancy that condition is known as preeclampsia. Many studies have shown that physically active women are less prone to develop GDM as compare to those women who have sedentary life style which draws attention towards the role of antenatal exercises for prevention and management of GDM and has become the first line treatment in developed countries. In addition to obesity and sedentary life style other known risk factors are family history, age of mother and number of children but there is no definite single cause of GDM yet discovered. Exercises programs during pregnancy are not usually practiced in our population and routine domestic activities are considered as enough for fitness. We have a common myth that pregnant women should not do treadmill or stationary cycle or any other aerobic activity which is really wrong and resulting in problems like GDM. Women following moderate exercise programs during their pregnancy have reported reduction in daily insulin administration dosage in comparison with women not doing any prescribed exercise. As Gestational weight gain is a major risk factor for GDM, exercises have given evidence to facilitate weight reduction. Exercise programs prescribed by physical therapists during pregnancy for preventing and managing GDM are considered useful and recommended by researchers and practitioners around the world but in developing countries like Pakistan, women are not receiving this method of treatment due to lack of awareness in general public, lack of referral system from gynaecologists and obstetricians and unavailability of women health Physical therapists in hospital set ups. This study will provide data showing the effects of exercise in biomarkers level and give the option of treatment to obstetricians. This will fill the research gap in the area of rehabilitation in GDM. This will also highlight the importance of women health physical therapists in obstetric conditions as there is less awareness of this speciality in Pakistan. This will provide the data regarding which type, intensity and duration of exercise should be recommendable while treating GDM. This study will open new doors for researchers to do long term studies on different biomarkers with different exercise types.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
exercise, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured Exercise Group
Arm Type
Experimental
Arm Description
Structured Exercise Group will receive medical and dietary interventions like insulin plus structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min The combination of Stabilization exercise (10 repetitions) and PFM training ( 20 repetitions set). Relaxation therapy including Mitchells physiological relaxation technique (10 repeatitions) alongwith deep breathing exercises. Life style modification with postural guidance and back care would also be followed. Exercise dosage would be twice a week for 05 weeks while exercise duration will be 45 to 50 min session under Physio supervision and home plan of 10 min exercise daily. Total 150 min per week. Data will be recorded at baseline then after treatment of 5 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control Group will receive no structured exercise regime only the group will be receiving medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist due to ethical concerns and their outcomes will be observed at the baseline and then after 05 weeks.
Intervention Type
Other
Intervention Name(s)
Structured Exercise for Experimental (Structured Exercise) Group
Intervention Description
Structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min. The combination of Stabilization exercise (10 repeatitions) and PFM training ( 20 repeatitions set). Relaxation therapy including Mitchells physiological relaxation technique (10 repetitions) along with deep breathing exercises.
Intervention Type
Behavioral
Intervention Name(s)
Control treatment for both groups
Intervention Description
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.
Primary Outcome Measure Information:
Title
HbA1c
Description
HbA1c will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Time Frame
5 weeks
Title
Blood Pressure
Description
Change in the Values of Blood pressure will be assessed at base line and at the end of 5 weeks session.
Time Frame
5 weeks
Title
Lipid profile
Description
Lipid profile will be assessed at the base line and at the end of 5 weeks session
Time Frame
5 weeks
Title
Renal function test (RFT)
Description
RFT will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Time Frame
5 weeks
Title
C reactive protein
Description
C reactive protein will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.
Time Frame
5 weeks
Title
Heart rate
Description
Change in the heart rate will be assessed at base line and at the end of 5 weeks session.
Time Frame
5 weeks
Title
Respiratory rate
Description
Change in the respiratory rate will be assessed at base line and at the end of 5 weeks.
Time Frame
5 weeks
Title
Blood glucose level
Description
Change in the blood glucose level will be assessed at base line and at the end of 5 weeks session.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Gestational weight gain
Description
Gestational weight gain by recording weight of women in pounds and gestational age in weeks at baseline and then after 5 weeks.
Time Frame
5 weeks
Title
Edinburgh Post Natal Depression scale (Punjabi version)
Description
The score of Depression using Edinburgh Post Natal Depression scale (Punjabi version). Each answer is given on a score of 0-3 . Maximum score is 30 A score of 10 or higher indicates that depressive symptoms have been
Time Frame
5 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females only.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with age of 20 to 40 years and gestational age more than 20 weeks. Diagnosed Gestational diabetes mellitus patients Must be able to do 6 min walk test and lie under severity level 6 on the 0-10 Borg scale of breathlessness - Exclusion Criteria: 1. Diagnosed neurological and cardiopulmonary problems. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation University Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
45710
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26810272
Citation
Aviram A, Guy L, Ashwal E, Hiersch L, Yogev Y, Hadar E. Pregnancy outcome in pregnancies complicated with gestational diabetes mellitus and late preterm birth. Diabetes Res Clin Pract. 2016 Mar;113:198-203. doi: 10.1016/j.diabres.2015.12.018. Epub 2016 Jan 12.
Results Reference
background
PubMed Identifier
29063044
Citation
Wang C, Guelfi KJ, Yang HX. Exercise and its role in gestational diabetes mellitus. Chronic Dis Transl Med. 2016 Dec 20;2(4):208-214. doi: 10.1016/j.cdtm.2016.11.006. eCollection 2016 Dec.
Results Reference
background
PubMed Identifier
25864059
Citation
Bain E, Crane M, Tieu J, Han S, Crowther CA, Middleton P. Diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst Rev. 2015 Apr 12;(4):CD010443. doi: 10.1002/14651858.CD010443.pub2.
Results Reference
background
PubMed Identifier
26918922
Citation
Barquiel B, Herranz L, Hillman N, Burgos MA, Grande C, Tukia KM, Bartha JL, Pallardo LF. HbA1c and Gestational Weight Gain Are Factors that Influence Neonatal Outcome in Mothers with Gestational Diabetes. J Womens Health (Larchmt). 2016 Jun;25(6):579-85. doi: 10.1089/jwh.2015.5432. Epub 2016 Feb 26.
Results Reference
background
PubMed Identifier
26909480
Citation
Brankica K, Valentina VN, Slagjana SK, Sasha JM. Maternal 75-g OGTT glucose levels as predictive factors for large-for-gestational age newborns in women with gestational diabetes mellitus. Arch Endocrinol Metab. 2016 Feb;60(1):36-41. doi: 10.1590/2359-3997000000126.
Results Reference
background

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Effects of Structured Exercise Regime in Gestational Diabetes Mellitus

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