Clinical trial NCT04146740: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: exercise
pregnancy
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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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Primary outcomes:
measure: HbA1c
timeFrame: 5 weeks
measure: Blood Pressure
timeFrame: 5 weeks
measure: Lipid profile
timeFrame: 5 weeks
measure: Renal function test (RFT)
timeFrame: 5 weeks
measure: C reactive protein
timeFrame: 5 weeks
measure: Heart rate
timeFrame: 5 weeks
measure: Respiratory rate
timeFrame: 5 weeks
measure: Blood glucose level
timeFrame: 5 weeks
Secondary outcomes:
measure: Gestational weight gain
timeFrame: 5 weeks
measure: Edinburgh Post Natal Depression scale (Punjabi version)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Wardah Ajaz Qazi, BS-PT, PP-DPT, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.