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Effects of Structured Exercise Regime in Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT04146740
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Foundation University Islamabad

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Other: Structured Exercise for Experimental (Structured Exercise) Group Behavioral: Control treatment for both groups Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Structured Exercise Regime for the Management of Gestational Diabetes Mellitus (GDM) - Bio Psychosocial Perspectives.
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Structured Exercise Group

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.

Other: Structured Exercise for Experimental (Structured Exercise) Group

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.


Behavioral: Control treatment for both groups
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.

Active Comparator: Control Group
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.
Behavioral: Control treatment for both groups
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 5 weeks ]
    HbA1c will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.

  2. Blood Pressure [ Time Frame: 5 weeks ]
    Change in the Values of Blood pressure will be assessed at base line and at the end of 5 weeks session.

  3. Lipid profile [ Time Frame: 5 weeks ]
    Lipid profile will be assessed at the base line and at the end of 5 weeks session

  4. Renal function test (RFT) [ Time Frame: 5 weeks ]
    RFT will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.

  5. C reactive protein [ Time Frame: 5 weeks ]
    C reactive protein will be assessed at the base line and at the end of 5 weeks session. Lower score shows better outcome.

  6. Heart rate [ Time Frame: 5 weeks ]
    Change in the heart rate will be assessed at base line and at the end of 5 weeks session.

  7. Respiratory rate [ Time Frame: 5 weeks ]
    Change in the respiratory rate will be assessed at base line and at the end of 5 weeks.

  8. Blood glucose level [ Time Frame: 5 weeks ]
    Change in the blood glucose level will be assessed at base line and at the end of 5 weeks session.


Secondary Outcome Measures :
  1. Gestational weight gain [ Time Frame: 5 weeks ]
    Gestational weight gain by recording weight of women in pounds and gestational age in weeks at baseline and then after 5 weeks.

  2. Edinburgh Post Natal Depression scale (Punjabi version) [ Time Frame: 5 weeks ]
    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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only.
Accepts Healthy Volunteers:   No
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146740


Contacts
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Contact: Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD* +923212042129 warda.qazi@fui.edu.pk

Locations
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Pakistan
Foundation University Islamabad Recruiting
Islamabad, Federal, Pakistan, 45710
Contact: Wardah Ajaz Qazi, BSPT, PPDPT, PhD*    +923212042129    warda.qazi@fui.edu.pk   
Sponsors and Collaborators
Foundation University Islamabad
Investigators
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Principal Investigator: Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD* Foundation University Islamabad

Publications:
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Responsible Party: Foundation University Islamabad
ClinicalTrials.gov Identifier: NCT04146740     History of Changes
Other Study ID Numbers: FUI/CTR/2019/1
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foundation University Islamabad:
exercise
pregnancy
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs