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February-A 2021, Volume 71, Issue 2

NOTE OF CONCERN

Article published in Journal of Pakistan Medical Association J Pak Med Assoc.February 2021, No. 2-A,Volume 72 Pages 505-507.

This editorial expression of concern serves to notify readers that the Editorial Board has identified discernible weaknesses in the study design, statistical concerns and conclusion drawn regarding this previously published article, titled: "Effects of structured exercise regime on lipid profile and renal function tests in gestational diabetes mellitus patients-A pilot study" J Pak Med Assoc. Vol. 71, No. 2-A, February 2021pages 505-507.

The Editorial Board has determined that :

  • 1. The article did not discuss the feasibility of the pilot study, instead attempted to draw inference from the analytical outcomes, which does not allow readers to interpret the desired implications correctly.
  • 2. The statistical methods applied were not at par and did not use the baseline data. The authors did not make full use of the data to add to the scientific weightage of the study, which could have been reported in the text.
  • 3. The conclusion only points towards the positive impacts on serum markers for diabetes mellitus and renal functions. Considering the very small sample size used, this is an unjustified extrapolation. The authors did not attempt to mention the feasibility of the whole process, including participants' willingness, management, and resources that should have been assessed and reported to benefit the planning of the full-scale RCT.

The editorial board of JPMA decided to publish this editorial expression of concern when we were made aware of deficiencies in the published article so that future researchers can plan their work on better scientific footings.



Pilot Study

Effects of structured exercise regime on lipid profile and renal function tests in gestational diabetes mellitus patients:A pilot study

Wardah Ajaz Qazi  ( Institute of Rehabilitation Sciences (FUIRS), Foundation University Islamabad )
Muhammad Naveed Babur  ( Isra Institute of Rehabilitation Sciences, Islamabad, Pakistan )
Arshad Nawaz Malik  ( Ripah International University, Lahore Campus, Pakistan )
Nadia Ahmed Bokhari  ( Foundation University Medical College, Fauji Foundation Hospital, Islamabad, Pakistan. )
Mirza Shamim Baig  ( Isra Institute of Rehabilitation Sciences, Isra University, Islamabad, Pakistan )
Ruqia Begum  ( Institute of Rehabilitation Sciences, Foundation University Islamabad, Pakistan )

Abstract

Objective: To determine the effects of structured exercise regime on biochemical markers of patients of gestational diabetes mellitus during the third trimester.

Methods: The two-arm pilot study was conducted at the Fauji Foundation Hospital, Rawalpindi, Pakistan, from March to July 2019, and comprised women aged 20-40 years with gestational age >20 weeks who were diagnosed with gestational diabetes mellitus and who were able to do 6min walk test under severity level on the 0-10 Borg scale. The subjects were randomized into two groups using the sealed envelope method. The intervention group received 5 weeks of structured exercise programme. including aerobics, stabilisation and pelvic floor muscle training, while the control group only received postural education. Data was noted at baseline and after intervention, and was analysed using SPSS 20.

Results: Of the 16 subjects, there were 8(50%) in each of the two groups. The mean age was 31.5±4.17 years in the interventional group and it was 35.0±6.30 years in the control group. Serum low-density lipoprotein and serum creatinine showed significant differences between the groups (p<0.05), while the rest of markers were non-significant (p>0.05).

Conclusion: Structured exercise regime was found to have a positive effect in reducing serum low-density lipoprotein and serum creatinine levels in gestational diabetes mellitus during the third trimester.

Keywords: Gestational diabetes mellitus, Lipid profile, Renal function tests, Structured exercise regime, Third trimester. (JPMA 71: 505; 2021)

DOI: https://doi.org/10.47391/JPMA.1052

 

Introduction

 

Gestational diabetes mellitus (GDM) is diagnosed after 24th gestational week and persists only during pregnancy, resulting in complications for both the mother and the offspring even later in life.1 The alarming increase in GDM prevalence has been reported by various systematic reviews as 16% globally, 13.2%, in Germany up to 17.5% in China, 11.5% in Asia, and up to 21% in India.2 Pakistan needs to figure out strategies for prevention and management of GDM. Exercise has been helpful in improving glucose homeostasis and supported by literature that difference has been observed in women doing exercise during pregnancy and those who are not following any antenatal exercise.3 It is suggested by the American Diabetes Association and the International Federation of Gynaecology and Obstetrics that lifestyle modification strategies, including physical activity, should be incorporated in GDM management.4 In Pakistan, observational studies have found positive association of physical activity and maternal obesity with GDM.5 Systematic review is available comparing GDM patients and non-GDM women,6 recommending more researches for finding treatment options related to dyslipidaemia in GDM patients. Regarding lipid profile, a study in Pakistan has reported significantly higher values of total cholesterol (TC), low-density lipoprotein (LDL_ and triglycerides (TG) (p<0.05) in GDM patients.7 A study in India found higher levels of serum creatinine in GDM patients compared to non-GDM patients, while no significant difference in urea levels was reported.8

The current study was planned to identify the actual effects of structured exercise with specific type intensity and duration of exercise on biochemical markers.

 

Subjects and Methods

 

The pilot, two-arm randomised controlled trial (RCT) was conducted at the Fauji Foundation Hospital, Rawalpindi, Pakistan, from March to July 2019, and was registered with the United States (US) National Library of Medicine (Protocol ID: FUI/CTR/2019/1).

After approval from the ethics review committee of Foundation University, Islamabad, the sample was raised using non-probability purposive sampling technique. Those included were women aged 20-40 years with gestational age >20 weeks with diagnosed GDM who were able to do 6 min walk test and would lie under severity level on the 0-10 Borg scale of breathlessness.9 GDM patients diagnosed with neurological and cardiopulmonary problems were excluded.

After taking consent from the subjects, they were randomised into two groups using the sealed envelope method. The structured exercise regime (SER) group received medical and dietary interventions, like insulin, plus structured exercise regime consisting of aerobic exercise of moderate intensity by using stationary cycle (3-5 metabolic equivalent [MET]) 10 min and brisk walk for 10 min combined with stabilisation exercise 10 repetitions and pelvic floor muscle (PFM) training 20 repetitions. Lifestyle modification with postural guidance and back care was given to the participants. Exercise was done twice a week for 05 weeks while exercise duration was 45-50 min per session under the supervision of a physical therapist, and home plan of 10 min exercise daily. The control (CTL) group received no structured exercise regime. They were on medical and dietary interventions, like insulin, and were given postural education and back-care from physical therapists due to ethical concerns.

Data was collected using self-structured questionnaire regarding demographics, family history, gravid, para and body mass index (BMI) while blood samples were taken for lipid profile and renal function tests at baseline and after 5 weeks in interventions for both groups. Data was analysed using SPSS 20. Demographics were reported as mean and standard deviation. Shapiro Wilk test found that LDL, high-density lipoprotein (HDL), TC, TG and urea data at baseline was not normally distributed, and, hence, for inter-group analysis, non-parametric Mann-Whitney U test was used. Serum creatinine at baseline showed normal distribution, and, hence, Independent t test was applied. P<0.05 was considered significant.

 

Results

 

Of the 30 patients screened, 18(60%) were included, but 2(11%) of them declined to participate, and the study was completed by 16(89%) subjects; 8(50%) in each of the two groups.  Overall 6(37.5%) patients reported positive family history of diabetes; 14(87.5%) were housewives; and 2(12.5%) were working women. The mean age was 31.5±4.17 years in SER group and it was 35.0±6.30 years in CTL group. Gravida and para status of the two groups was also noted (Table 1).

Serum LDL showed significant improvement (p=0.01), while the difference was not significant for HDL, TC, TG and urea (p>0.05) (Table 2).

Serum creatinine showed significant difference (Table 3).

 

Discussion

 

The current study was the first of its kind in Pakistan to evaluate biochemical markers along with exercise so that proper lifestyle strategies should be defined for GDM patients with evidence. Many studies have identified the role of exercise for GDM, but actual frequency, intensity and duration of exercise still need to be addressed.3 One RCT done on obese pregnant women found effects of exercise on overall aerobic fitness, but not on weight-gain and fat mass.10 One study identified the hike in levels of TC, LDL and TG during pregnancy and also their association with DGM development as significant difference was found between GDM and LDL levels during the third trimester, and TG levels >216mg/dl during the third trimester could become the cause of GDM.11 Similarly, in the current study, high levels of LDL and TH were observed in GDM patients during their third trimester. A meta-analysis done on assessing the role of exercise in prevention of GDM indicated significant decrease, but did not find its effects on glycaemic control in detail.12 Another systematic review concluded better outcomes in exercise group compared to dietary interventions group in diagnosed GDM patients, but it also recommended further studies on biochemical markers.13 Although the current pilot study was done on diagnosed GDM patients and found significant results in lowering LDL through exercise, but the factor is needed to be studied on a large sample size. An RCT was done on 456 patients to evaluate the effects of aerobics exercise on maternal weight between intervention and control groups and revealed that the control group showed higher prevalence of obesity compared to the intervention group which was following aerobics during pregnancy,14 which is in line with the current study. There is a need to conduct such experimental studies on a large scale to further evaluate the role of exercise on lipid profile and renal function tests. Moreover, inflammatory biomarkers should also be included.

 

Conclusion

 

Structured exercise regime had a positive effect in reducing serum LDL and serum creatinine levels in GDM patients during their third trimester. It should be added in the interdisciplinary management of GDM patients.

 

Disclaimer: The manuscript is a part of Ph.D thesis.

Conflict of interest: None.

Source of Funding: None.

 

References

 

1.      Benhalima K, Jegers K, Devilegers R. Glucose Intolerance after a Recent History of Gestational Diabetes Based on the 2013 WHO Criteria. PLoS One 2016; 11: e0157272.

2.      Gao C, Sun X, Lu L, Liu F, Yuan J. Prevalence of gestational diabetes mellitus in mainland China: A systematic review and meta-analysis. J Diabetes Investig 2019; 10: 154-62.

3.      Wang C, Guelfi KJ, Yang HX. Exercise and its role in gestational diabetes mellitus. Chronic Dis Transl Med 2016; 2: 208-14.

4.      Zhao P, Liu E, Qiao Y, Katzmarzyk PT, Chaput JP, Fogelholm M, et al. Maternal gestational diabetes and childhood obesity at age 9-11: results of a multinational study. Diabetologia 2016; 59: 2339-48.

5.      Jahan S, Qazi W, Khalid M, Rafi U. Association of gestational diabetes mellitus with maternal obesity and preeclampsia: hospital-based cross-sectional study. Khyber Med Uni J 2018; 10: 19-22.

6.      Huynh J, Xiong G, Bentley-Lewis R. A systematic review of metabolite profiling in gestational diabetes mellitus. Diabetologia 2014; 57: 2453-64.

7.      Alyas S, Roohi N, Ashraf  S, Ilyas S, Ilyas A. Early pregnancy biochemical markers of placentation for screening of gestational diabetes mellitus (GDM). Diabetes Metab Syndr 2019; 13: 2353-6.

8.      Khan R, Ali K, Khan Z, Ahmad T. Lipid profile and glycosylated hemoglobin status of gestational diabetic patients and healthy pregnant women. Indian J Med Sci 2012; 66:149-54.

9.      Intarakamhang P, Wangjongmeechaikul P. The assessment of dyspnea during the virorous intensity exercise by three dyspnea Rating Scales in inactive medical personnel. Glob J Health Sci 2013; 5: 19-29

10.    Seneviratne SN, Jiang Y, Derraik J, McCowan L, Parry GK, Biggs JB, et al. Effects of antenatal exercise in overweight and obese pregnant women on maternal and perinatal outcomes: a randomised controlled trial. BJOG 2016; 123: 588-97.

11.    Ghodke B, Pusukuru R, Mehta V. Association of Lipid Profile in Pregnancy with Preeclampsia, Gestational Diabetes Mellitus, and Preterm Delivery. Cureus 2017; 9: e1420.

12.    Yu Y, Xie R, Shen C, Shu L. Effect of exercise during pregnancy to prevent gestational diabetes mellitus: a systematic review and meta-analysis. J Matern Fetal Neonatal Med 2018; 31: 1632-7.

13.    Allehdan SS, Basha AS, Asali FF, Tayyem RF. Dietary and exercise interventions and glycemic control and maternal and newborn outcomes in women diagnosed with gestational diabetes: Systematic review. Diabetes Metab Syndr 2019; 13: 2775-84.

14.    Barakat  R, Refoyo I, Coteron J, Franco E. Exercise during pregnancy has a preventative effect on excessive maternal weight gain and gestational diabetes. A randomized controlled trial. Braz J Phys Ther 2019; 23: 148-55.

 

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