Effects of Structured Exercise Regime in Gestational Diabetes Mellitus
NCT ID: NCT04146740
Last Updated: 2020-08-31
Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-03-12
2020-08-27
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Control treatment for both groups
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.
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.
Control treatment for both groups
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.
Interventions
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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.
Control treatment for both groups
Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.
Eligibility Criteria
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Inclusion Criteria
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
\-
20 Years
40 Years
FEMALE
No
Sponsors
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Foundation University Islamabad
OTHER
Responsible Party
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Principal Investigators
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Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD*
Role: PRINCIPAL_INVESTIGATOR
Foundation University Islamabad
Locations
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Foundation University Islamabad
Islamabad, Federal, Pakistan
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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FUI/CTR/2019/1
Identifier Type: -
Identifier Source: org_study_id