Response to a Supervised Structured Aerobic Exercise Training Program in Patients with Type 2 Diabetes Mellitus – Does Gender Make a Difference? A Randomized Controlled Clinical Trial

Response to a Supervised Structured Aerobic Exercise Training Program in Patients with Type 2 Diabetes Mellitus – Does Gender Make a Difference? A Randomized Controlled Clinical Trial

Response to a Supervised Structured Aerobic Exercise Training Program in Patients with Type 2 Diabetes Mellitus e Does Gender Make a Difference? A Ran...

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Response to a Supervised Structured Aerobic Exercise Training Program in Patients with Type 2 Diabetes Mellitus e Does Gender Make a Difference? A Randomized Controlled Clinical Trial Syed Shakil-ur-Rehman, Ph.D. Student., Hossein Karimi, Ph.D., Syed Amir Gillani, Ph.D., Imran Amjad, M.Phil., Shakeel Ahmad, M.S., Amna Yaseen, M.S.

Competing interests: None declared. Funding: Yes by Riphah International University, Islamabad, Pakistan. Acknowledgements: None declared. Abstract: Objective: Because of the globally increasing occurrence of diabetes mellitus (DM) in the population, exercise is becoming vitally important for prevention and disease management, along with medical and dietary interventions. This study was designed to test the hypothesis that women with DM would respond similarly to men with DM following supervised structured aerobic exercise training (SSAET) program. Methods: This randomized, single blind, controlled clinical trial was conducted on 102 patients with T2DM with ranging in age from 40 to 70 years. All the participants were randomly allocated to either an experimental or a control group. The experimental group participated in an SSAET program, routine medication, and dietary plan, while the control group was treated with routine medication and dietary plan, for 25 weeks. Assessments of physical and biochemical variables were carried out at baseline and after 25 weeks’ intervention and gender-based response to the SSAET program was analyzed. Results: Both the male and female patients responded to 25 weeks of SSAET, routine medication, and dietary plan equally in the experimental group, whereas in the control group IL-6 and NOS-1 showed slight differences. All male and female patients in the experimental group treated with SSAET, routine medication, and dietary plan showed significant improvement in all variables (P < 0.05), while in the control group, deterioration or no change was noted except in HDL and LDL. Conclusion: SSAET is equally effective in both male and female patients with T2DM when compared with a non-exercise control group, but no gender-based difference was found. (Trial ID ISRCTN16466697/ http://orcid.org/0000-0002-6682-9896). Keywords: Type 2 diabetes mellitus-Supervised structured aerobic exercise training-Gender-based response

Author affiliations: Syed Shakil-ur-Rehman, University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, Lahore, Pakistan; Riphah College of Rehabilitation Sciences, Riphah International University, Plot#50, St#05, Faiz Ahmad Faiz Road, H-8/2, Islamabad, Pakistan; Hossein Karimi, University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, 1- kilometre Defence Road, Lahore, Pakistan; Syed Amir Gillani, Faculty of Allied Health Sciences, University of Lahore, 1kilometre Defence Road, Lahore, Pakistan; Imran Amjad, Riphah College of Rehabilitation Sciences, Riphah International University, Plot#50, St#05, Faiz Ahmad Faiz Road, H-8/2, Islamabad, Pakistan; Shakeel Ahmad, Riphah College of Rehabilitation Sciences, Riphah International University, Plot#50, St#05, Faiz Ahmad Faiz Road, H-8/2, Islamabad, Pakistan; Amna Yaseen, Riphah College of Rehabilitation Sciences, Riphah International University, Plot#50, St#05, Faiz Ahmad Faiz Road, H-8/2, Islamabad, Pakistan Correspondence. Syed Shakil-ur-Rehman, Ph.D., University Institute of Physical Therapy, Faculty of Allied Health Sciences, University of Lahore, Lahore, Pakistan., email: shakil. [email protected] ª 2017 by the National Medical Association. Published by Elsevier Inc. All rights reserved.

https://doi.org/10.1016/j.jnma.2017.10.003

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INTRODUCTION

D

iabetes Mellitus (DM) is a metabolic disorder which produces chronic hyperglycemia caused by a defect in insulin secretion and causes damage, dysfunction, and failure to many organs including the heart, kidneys, skin, eyes, and blood vessels.1 DM is among the few diseases affecting the human population in greater numbers as the population has aged in the past several decades.2 Currently DM is a global challenge for health care professionals due to the growing diabetic population and multi-systemic complications in the human body. In 2013 the victims of DM numbered 382 million, which is, 6.4% of the global population. This number is likely to reach 592 million in 2035, which will indeed be a major increase compared to 1985, when the total DM population was 30 million. Developing countries will be affected more compared to developed countries.3 Although DM comprises many types of disease, type 2 DM is the most common, totaling about 90e95% of patients.4 In the United States of America, diabetic patients totaled 11 million in 2000, and this number is likely to increase 165% to 29 million in 2050, from 4% to 7.2% of the total population. This projection is greater in the group aged >75 years, with increases of 271% in females and 437% in males.5 In China 92.4 million people are suffering from diabetes, with 50.2 million males and 42.2 million females.6 In Asian countries, the number of diabetic patients is higher among Indian patients (peak age 70 years) compared to Chinese and Japanese patients (peak age 70e89 years), and this difference increases with age.7 The prevalence of the diabetic population in Pakistan was 6.8% in 2013, and is projected to rise to 8.1% of the total population by 2035.3 Standardized management of T2DM includes lifestyle modifications and pharmacological interventions. The lifestyle modifications comprise dietary recommendations, physical activity, and exercise.8 Metformin is indicated as

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the initial pharmacological intervention, and because of the progressive nature of T2DM insulin therapy is recommend in advance stages, especially when other pharmacological intervention fail. Medical nutrition therapy (MNT) should also be the part of a treatment plan, with emphasis on obesity management through weight loss. In the case of T2DM, regular aerobic physical activity of moderate intensity (150 min per week for 3 days) is recommended by the American Diabetic Association (ADA), along with resistance training twice per week in the absence of postdiabetic complications.9 Positive effects of physical activity and exercise are evident from the literature; they are multi-purpose and multi-systemic, while focusing on prevention and management of both at-risk persons and diagnosed T2DM patients.10 With first-time intervention, chronic exercise training may cause improvements in plasma glucose, body composition, insulin resistance and glycated hemoglobin (HbA1c) although T2DM patients have difficulty implementing an exercise program.11 A long-term exercise program along with dietary intervention and lifestyle changes can significantly prevent or postpone the occurrence of diabetes.12 Literature supports that increased physical activity (150 min per week) and modest weight loss (5e7%) can reduce the risk by 58% from the impaired glucose tolerance (IGT) to T2DM.13,14 Exercise has marked positive effects on glycemic control, visceral adipose tissues, and triglycerides in patients with T2DM.15,16 Regular structured exercise positively influences the VO2max in patients with T2DM, and with increasing intensity exercise leads to noticeable improvements in glycated hemoglobin (HbA1c) and cardiopulmonary fitness.17 An aerobic exercise program improves high-density lipoprotein (HDL) and low-density lipoprotein (LDL) in patients with T2DM, when applied with supervision using a treadmill with proper structure of time, intensity, and inclination.18 There are many significant effects of exercise in patients with T2DM ranging from prevention to management, but no evidence was found in the literature on the gender-specific effects of physical activity and exercise programs in patients with T2DM. Therefore, the current study was designed with the objective to test the hypothesis that women with DM would respond similarly to men with DM following supervised structured aerobic exercise training (SSAET) program.

MATERIALS AND METHODS This randomized, single blind, controlled clinical trial was conducted at Riphah Rehabilitation and Research Center (RRRC) at Islamic International Medical College

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Trust (IIMCT) Pakistan Railways General Hospital in Rawalpindi, Punjab, Pakistan, from January 1, 2015, to March 31, 2016. Male and female patients aged 30e70 years and diagnosed withT2DM in accordance with WHO criteria were included, whereas individuals with post stroke, Parkinson syndrome, heart failure, acute myocardial infarction, COPD, knee osteoarthritis, and diabetic foot were excluded.19 A screening program was carried out per the inclusion criteria on a total of 195 patients, of which 120 fulfilled the criteria and 102 patients (mean age ¼ 54.73 ± 08.17 years) were willing to be enrolled in the study. All 102 study participant were randomly placed into experimental (n ¼ 51) and control (n ¼ 51) groups by lottery method based on exercise and non-exercise group. A total of 36 patients were males (mean age ¼ 59.12 ± 05.78 years) and 15 were females (mean age ¼ 51.31 ± 8.78 years) in the experimental group, while 32 were females (mean age ¼ 57.93 ± 06.83 years) and 19 were males (mean age ¼ 55.00 ± 08.03 years) patients in the control group. Sample size for the current study was calculated through a pilot study on 20 patients (10 patients in each group) by an online calculator called “Epi Tools.” Statistical parameters were mean of insulin resistance (IR) in the experimental group (0.4340), mean of IR in the control group (0.6402), variance (0.137), confidence level (0.95), and power (0.8) that resulted in 51 patients per group and a total sample size of 102. This clinical trial was in accordance with the Declaration of Helsinki and approved by the Ethical Review Committee (ERC) of Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan. Written informed consent was obtained from all study participants in the Urdu language before enrollment in the study. This trial was registered on the ISRCTN registry website with Trial ID ISRCTN16466697. The SSAET program, routine medication, and dietary plan were the intervention for the experimental group, whereas the control group was kept on routine medication and dietary plan for the period of 25 weeks. Routine medication comprised of all medications advised by the physician and regularly monitored through periodic visits to the diabetic clinic. Patients were allowed to continue on their home medication and not comparable between two groups and changed as per need in all study participants by the physician as part of routine treatment plan. The SSAET program was divided into 5 phases, with each phase 5 weeks’ duration, 3 days per week. A medically graded treadmill was used for exercise intervention, and the inclination was 0 in phase 1, 3 in phase 2, and increased by 3 in every subsequent phase,

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until finally it was 12 in phase 5. Normal speed of each participant was calculated prior to the intervention Response to exercise was analyzed on Physical variables, biochemical variables, inflammatory markers and lipid profile. Physical variables were rate of perceived exertion (RPE), dyspnea, body mass index (BMI), and VO2max, and assessed by a modified Borg scale of perceived exertion, dyspnea index, BMI calculation formula (weight in kg/ height in meters squared), and VO2max by the resting heart rate method.20e22 Biochemical variables included fasting blood glucose level (FBGL), glycemic control (HbA1c), plasma insulin level (PIL) and insulin resistance (IR). Inflammatory markers were interleukin-6 (IL-6), nitric oxide synthase (NOS-1), and cyclooxygenase-2 (COX2). Lipid profile consisted HDL and LDL by a 20 m walk test, and the result was used as a treadmill speed. Duration of the exercise program was 30 min per week in phase 1 (10 min per session), and increased by 30 min in each subsequent phase, until finally it was 150 min per week (50 min of each session) in phase 5. A glucometer was used for the direct testing of FBGL.23 HbA1c was estimated from an ethylenediaminetetraacetic (EDTA) blood sample (2 ml in purple tube) with a kit made by Tianjin MD Pacific Technology Company, China.24 The PIL was estimated from blood serum (2 ml in yellow tube) after centrifuging it for 10 min using a microlisa human insulin kit made by Amgenix USA.25 The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) method was used for the calculation of IR using the formula: IR¼ (insulin mU/L x glucose mg/dl)/405.26 HDL and LDL were estimated by the direct enzymatic method using a kit made by AMEDA Labordiagnostik, Austria.27,28 Estimation of IL-6 was carried out by an AssayMax Human IL-6 kit made by Assaypro Co, USA, NOS-1 by a human NOS1 ELISA kit made by Elabscience, China, and COX2 by a human prostaglandin-2 ELISA kit made by Cusabio Biotech Co, USA.29,30 The Postgraduate research lab of Islamic International Medical College (IIMC) was used for the laboratory work and storage of the blood samples. All the physical and biochemical parameters were assessed at the baseline before intervention and the completion of the 25-week intervention period. Genderbased analysis of the data was done through SPSS software version-21 and a Shapiro-Wilk test was applied to check the normality of the data. The data of FBGL, PIL, GC, HDL, IL-6, NOS-1, and COX2 was found to be normally distributed, and a parametric test was applied to assess the differences between the groups (independent t-test) and within the groups (paired t-test); while the data of IR, LDL, and LPE was found not normally distributed,

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and a non-parametric test was applied to assess the differences between the groups (Mann-Whitney test) and within groups (Wilcoxon test).

RESULTS No gender-based difference was found in the experimental group treated with the SSAET program, routine medication, and dietary plan for 25 weeks. Detailed results including post-treatment mean, standard deviation, and p-value in the case of the parametric test, and mean ranks and p-value in the case of the non-parametric test, are given in Table 1.

DISCUSSION Although exercise is a key modality for the prevention and management of T2DM, certain parameters still need to be explored such as the gender-based response of the diabetic population to exercise. Literature supports that there are gender differences in many ways, but the results of the current study suggest that there is no difference among male and female T2DM patients when exposed to a 25- week SSAET program, routine medication, and dietary plan. The same results were also found in male and female patients in a non-exercise group treated with 25 weeks of routine medication and dietary plan. Very limited studies have addressed gender-based difference in patients with T2DM. Vilhjalmsson and colleagues conducted a study on gender differences in physical activity in geriatric, children, and adolescents, and assessed the central role of organized sport. They reported no marked difference in overall activity levels or strenuous physical activity in male versus female participants registered at a fitness club.31 Schuster and colleagues conducted a study on gender differences in cardiac rehabilitation patients. They assessed adherence, activity tolerance, self efficacy, and anxiety. Their final conclusion was that there were no significant differences in demographic and assessment variations between the male and female genders.32 On the other hand, some studies supported gender differences in response to physical activity and exercise. Perreault and colleagues conducted a study on gender differences in diabetes risk and the effect of intensive lifestyle modification in a diabetes prevention program. In conclusion, they stated that a body weight loss of greater than 3% minimized the risk of diabetes in both male and female participants of the study.33 The current study showed that T2DM patients of both genders showed greater improvement in all physical and biochemical variables in a exercise group treated with a

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Table 1. Details of statistical analysis among the male and female patients in the experimental group.

Pre intervention Mean ± SD

Study variables

Gender

Fasting blood glucose level

Male

274.50 ± 27.13

Female

277.28 ± 24.80

Glycemic control (HbA1C)

Male

8.33 ± 1.53

Female

8.30 ± 1.92

Plasma insulin level

Male

12.85 ± 3.69

Female

14.03 ± 5.91 60.66 ± 19.11

Insulin resistance

Male Female

66.92 ± 30.32

High density lipoprotein

Male

39.62 ± 4.74

Female

44.11 ± 8.90

Low density lipoprotein

Male

113.00 ± 13.02

Female

121.11 ± 21.07

Interleukin-6

Male

0.219 ± 0.089

Female

0.270 ± 0.116

Nitric oxide synthase 1

Male

4.85 ± 1.12

Female

5.01 ± 1.05 18.57 ± 3.82

Cyclooxygenase-2

Male Female

18.79 ± 4.72

Rate of perceived exertion

Male

89.28 ± 25.69

Female

97.45 ± 41.10

Dyspnea level

Male

15.37 ± 1.62

Female

14.65 ± 2.12

Body mass index

Male

31.15 ± 5.64

Female

29.40 ± 5.15

VO2 max

Male

36.18 ± 3.78

Female

37.22 ± 2.18

P-value 0.730

Post intervention Mean ± SD 257.56 ± 24.91

P-value 0.180

246.65 ± 29.32 0.952

7.33 ± 1.47

0.887

7.26 ± 1.47 0.393

9.06 ± 4.38

0.869

8.85 ± 3.62 0.376

38.87 ± 15.07

0.064

44.62 ± 4.99

0.756

37.52 ± 16.00 0.026

48.77 ± 7.66 0.100

97.87 ± 6.06

0.026

104.82 ± 15.05 0.091

0.190 ± 0.043

0.422

0.201 ± 0.048 0.649

2.71 ± 1.33

0.288

3.15 ± 1.42 0.866

15.27 ± 3.16

0.393

62.93 ± 30.46

0.888

15.14 ± 2.40 0.868

61.46 ± 25.18 0.118

11.93 ± 1.87

0.118

10.94 ± 2.41 0.298

29.01 ± 5.04

0.220

27.14 ± 4.71 0.317

39.31 ± 2.84

0.157

40.48 ± 2.18

No genderebased difference was found in the control group treated with routine medication and dietary plan for 25 weeks, except IL6 and NOS-1 showed slight differences. Detailed results including post-treatment mean, standard deviation, and p-value in the case of the parametric test, and mean ranks and p-value in the case of the non-parametric test, are given in Table 2.

25-week SSAET program, routine medications, and a dietary plan, while the non-exercise group treated with routine medication and dietary plan demonstrated deterioration or no change. Boule and colleagues conducted a meta-analysis and analyzed the effects of exercise in T2DM patients on glycemic control. After a systematic literature search they found 12 randomized controlled trials on aerobic training and 2 on resistance training. They reported a reduction in glycemic controlled HbA1c in their conclusion.16

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Bollinger and group carried out a study and assessed the literature on exercise and IR. In their final conclusion they recommended that exercise is a modality which positively influenced IR in patients with T2DM.34 The results of the present study also reported a positive change in a group of patients with T2DM who underwent a 25week SSAET program, routine medication, and dietary plan. Thomas and team analyzed the acute versus chronic effects of exercise in patients with T2DM, and they reported significantly positive effects of exercise on blood

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Table 2. Details of statistical analysis among the male and female patients in the control group.

Pre intervention mean ± SD

Study variables

Gender

Fasting blood glucose level

Male

258.33 ± 27.18

Female

272.30 ± 19.17

Glycemic control (HbA1C)

Male

7.48 ± 1.68

Female

8.43 ± 1.71

Male

16.05 ± 7.03

Female

13.35 ± 4.57

Insulin resistance

Male

69.95 ± 28.89

Female

62.22 ± 21.12

High density lipoprotein

Male

42.73 ± 10.73

Female

43.63 ± 6.96

Plasma insulin level

123.60 ± 22.55

Low density lipoprotein

Male Female

113.55 ± 15.37

Perceived rate of exertion

Male

111.48 ± 48.86

Interleukin-6

Female

92.73 ± 31.79

Male

0.208 ± 0.088

Female

0.242 ± 0.085 3.31 ± 2.02

Nitric oxide synthase 1

Male

Cyclooxygenase-2

Male

17.41 ± 5.29

Female

18.94 ± 4.22

Dyspnea level

Male

13.46 ± 1.50

Female

14.63 ± 235

Body mass index

Male

28.66 ± 5.01

Female

30.46 ± 4.85

Male

37.73 ± 3.41

Female

38.11 ± 3.24

Female

VO2 max

P-value 0.085

Post intervention mean ± SD

P-value

274.40 ± 39.06

0.381

284.33 ± 27.56 0.081

7.99 ± 1.28

0.299

8.33 ± 1.50 0.186

16.03 ± 6.64

0.382

14.35 ± 4.60 0.360

73.45 ± 26.63

0.766

43.86 ± 10.22

0.634

69.68 ± 22.09 0.792

44.63 ± 6.99 0.130

114.73 ± 21.65

0.809

111.37 ± 46.17

0.274

107.86 ± 14.75 0.442

99.70 ± 31.96 0.227

0.230 ± 0.080

0.025

0.288 ± 0.075 0.869

3.31 ± 2.03

0.332

17.55 ± 5.09

4.73 ± 1.95

0.030

4.73 ± 1.96 0.162

19.74 ± 4.53 0.082

15.13 ± 1.68

0.470

16.27 ± 2.05 0.247

28.61 ± 4.90

0.176

30.72 ± 5.06 0.718

36.93 ± 3.34

0.774

37.22 ± 2.95

Although no gender-based difference was found and all male and female patients responded equally to the intervention in both the experimental and control groups, the patients in the experimental group who participated in the 25 weeks’ duration SSAET program, routine medication, and dietary plan showed greater improvements in all physical and biochemical variables except IL-6 (Table 3).In comparison, the patients in the control group treated with routine medication and dietary plan, showed deterioration or no change except for HDL and LDL, which improved slightly (Table 4).

lipids, blood pressure (BP), and insulin homeostasis and suggested that increasing the duration and intensity of exercise (from 40% to 70% of maximal capacity) can produced significant effects on glucose metabolism; however, this was not carefully examined during the study.35 The present study also reported that a significant change was noted in PIL, GC, and IR in those patients treated with 25 weeks’ SSAET, routine medication, and dietary plan, compared to the control group managed by

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routine medication and dietary plan for the same time duration. Mann and team carried out a research study and analyzed the effects of different types of exercises in a population with a deranged lipid profile. They suggested that high intensity aerobic exercise improves the lipid profile and positive change occurs in HDL, LDL, and triglycerides.36 The current study demonstrated the same results and reported significant improvements in HDL

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Table 3. Effects of supervised structured aerobic exercise training program along with routine medication and dietary plan in experimental group. (Exercise Group).

Test variables

Gender

Fasting blood glucose level (mean ± SD)

Male

274.50 ± 27.13

257.56 ± 24.91

0.012

Female

277.28 ± 24.80

246.65 ± 29.32

0.001

Post intervention

P-value

8.33 ± 1.53

07.35 ± 1.47

0.015

Glycemic control (HbA1C) (mean ± SD)

Male

8.30 ± 1.92

07.26 ± 1.44

0.001

Plasma insulin level (mean ± SD)

Male

12.85 ± 3.69

9.06 ± 4.38

0.027

Female

14.03 ± 5.91

8.85 ± 3.62

0.001

Female

Insulin resistance (mean ± SD) High density lipoprotein (mean ± SD) Low density lipoprotein (mean ± SD)

Male

60.66 ± 19.11

38.97 ± 15.07

0.004

Female

69.92 ± 30.32

37.52 ± 16.00

0.001

Male

39.62 ± 4.74

44.62 ± 4.99

0.001

Female

44.11 ± 8.90

48.77 ± 7.66

0.001

Male

113.00 ± 13.02

97.87 ± 6.60

0.001

Female

121.11 ± 21.07

104.82 ± 15.05

0.001

0.190 ± 0.043

0.150

Interleukin-6 (mean ± SD)

Male

0.219 ± 0.089

Female

0.270 ± 0.116

0.201 ± 0.048

0.000

Nitric oxide synthase (mean ± SD)

Male

4.85 ± 1.12

02.71 ± 1.33

0.001

Female

5.01 ± 1.05

03.15 ± 1.42

0.001

Cyclooxygenase-2 (mean ± SD)

Male

18.57 ± 3.82

15.27 ± 3.16

0.001

Female

18.79 ± 4.72

15.14 ± 2.40

0.001

Male

15.37 ± 1.62

11.93 ± 1.87

0.001

Female

14.65 ± 2.12

10.94 ± 2.41

0.001

Male

31.15 ± 5.64

29.01 ± 5.04

0.001

Female

27.14 ± 4.71

37.22 ± 2.18

0.001

VO2 max (mean ± SD)

Male

36.18 ± 3.78

39.31 ± 2.84

0.001

Female

37.22 ± 4.71

40.88 ± 2.18

0.001

Perceived rate of exertion (mean ± SD)

Male

10.50 ± 1.82

7.25 ± 1.39

0.001

Female

10.60 ± 1.55

7.45 ± 1.42

0.001

Dyspnea level (mean ± SD) Body mass index (mean ± SD)

and LDL levels in a group of patients with T2DM treated with a 25-week SSAET program, routine medication, and dietary plan, which is higher than that of the control group of T2DM patients who were treated with routine medication and dietary plan for the same time duration. Colbert and colleagues studied the association between physical activity and inflammatory markers in a cross-sectional study. They reported that levels of inflammatory markers (IL-6, CRP, and TNFa) decreased with increasing levels of physical activity and exercise in older adults.37 Jorge and team reported the positive effects of a 12-week exercise program on GC, inflammatory markers, and BP.38 In another study Ito and team reported that 8 weeks of regular treadmill running

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promoted up-regulation of NOS-1 in Zucker diabetic fatty (ZDF) rats.39 The present study also showed the positive effects of a 25-week SSAET program, routine medication, and dietary plan in patients with T2DM, compared to the non-exercise group who managed with routine medication and dietary plan and showed deterioration or no change. Maiorana and colleagues studied the effects of 8 weeks of a circuit training (CT) program along with resistance and aerobic training in patients with T2DM. They reported positive effects of the CT program on lean body mass, GC, cardiopulmonary fitness, and muscular strength.40 In another study Huebschmann and team reported that higher RPE was associated with increased levels of lactate, higher heart rate, and hypertension and is modifiable by regular

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Table 4. Effects of routine medication and dietary plan in the control group. (Non-exercise group).

Test variables

Gender

Fasting blood glucose level (mean ± SD)

Male

258.33 ± 27.18

274.40 ± 39.06

0.033

Female

272.30 ± 19.17

284.33 ± 27.56

0.009

Glycemic control (HbA1C) (mean ± SD)

Pre treatment

Post treatment

P value

Male

07.48 ± 1.68

07.99 ± 1.28

0.400

Female

08.43 ± 1.71

08.33 ± 1.50

0.694

Plasma insulin level (mean ± SD)

Male

16.05 ± 7.03

16.03 ± 6.64

0.948

Female

13.35 ± 4.57

14.35 ± 4.60

0.003

Insulin resistance (mean ± SD)

Male

62.22 ± 21.12

69.68 ± 22.09

0.001

Female

69.95 ± 28.89

73.45 ± 26.63

0.169

High density lipoprotein (mean ± SD)

Male

43.63 ± 6.97

44.63 ± 6.99

0.001

42.73 ± 10.73

43.86 ± 10.22

0.016

Low density lipoprotein (mean ± SD)

Male

123.60 ± 22.55

114.73 ± 21.65

0.001

Female

113.55 ± 15.37

107.86 ± 14.75

0.001

Female

Interleukin-6 (mean ± SD)

Male

0.209 ± 0.089

0.230 ± 0.080

0.339

Female

0.242 ± 0 .085

0.288 ± 0.075

0.001

Cyclooxygenase-2 (mean ± SD)

Male

17.41 ± 5.29

17.55 ± 5.09

0.614

Female

18.94 ± 4.22

19.74 ± 4.53

0.066

Nitric oxide synthase 1 (mean ± SD)

Male

4.69 ± 1.68

3.31 ± 2.03

0.020

Female

4.60 ± 1.61

4.73 ± 1.95

0.643

13.46 ± 1.50

15.13 ± 1.68

0.001

Dyspnea level (mean ± SD)

Male Female

14.63 ± 2.35

16.27 ± 2.05

0.001

Body mass index (mean ± SD)

Male

28.66 ± 5.01

28.61 ± 4.90

0.460

Female

30.46 ± 4.85

30.72 ± 5.06

0.003

Male

37.73 ± 3.41

36.93 ± 3.34

0.090

Female

38.11 ± 3.24

37.22 ± 2.95

0.008

Male

10.46 ± 1.50

11.86 ± 1.30

0.001

Female

10.58 ± 1.66

12.16 ± 1.10

0.001

VO2 max (mean ± SD) Perceived rate of exertion (mean ± SD)

and structured exercise in patients with T2DM.41 The present study also demonstrated greater improvements in dyspnea, RPE, Vo2max, and BMI through 25 weeks of a SSAET program, routine medication, and dietary plan compared to patients in the control group who were treated with routine medication and dietary plan. There were some limitations of the current study including unequal male and female groups, non comparable amount of routine medication and documentation of any change in it.

DECLARATION

CONCLUSION

Yes and can be provided on demand.

SSAET is equally effective in both male and female T2DM patients compared with non-exercise control group, and no gender-based difference was found.

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Ethical approval and consent to participate Yes.

Consent for publication Yes.

Availability of data and material

Authors’ information Yes.

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Authors’ contributions

exercise the 6-year Malmö feasibility study. Diabetologia, 34(12), 891e898.

Syed Shakil-ur-Rehman e idea, data collection and analysis, writing. Hossein Karimi e idea, methodology, writing and review and finally approval. Syed Amir Gillani e methodology, review. Imran Amjad e Data Collection and analysis. Shakil Ahmad e Data Collection and analysis. Amina Yaseen e Lab work.

13. Tuomilehto, J., Lindström, J., Eriksson, J. G., et al. (2001 May 3). Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med, 344(18), 1343e1350. 14. Diabetes Prevention Program Research Group. (2002 Feb 7). Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med, 2002(346), 393e403. 15. Thomas, D. E., Elliott, E. J., & Naughton, G. A. (2006 Jul). Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev, 3(3).

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