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CTRI Number  CTRI/2018/07/014705 [Registered on: 02/07/2018] Trial Registered Retrospectively
Last Modified On: 28/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA)
Other (Specify) [Structured Excercise therapy]  
Study Design  Other 
Public Title of Study   Evaluation of the effect of structured exercise therapy on neuro physiological and cognitive functions of young adults with type 2 diabetes mellitus. 
Scientific Title of Study   Evaluation of the effect of structured exercise therapy on neuro physiological and cognitive functions of young adults with type 2 diabetes mellitus- A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harpreet Kour 
Designation  Prncipal investigator 
Affiliation  JNMC, KLE University 
Address  Dept of Physiology, J.N.Medical College,Nehru Nagar Belagavi karnataka- 590010
.N.Medical College, KLE University, Nehru Nagar Belagavi karnataka- 590010
Belgaum
KARNATAKA
590010
India 
Phone  9620850326  
Fax  0831-2470759  
Email  harpreet.kour@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivprasad S Goudar 
Designation  Professor 
Affiliation  KLE University, Jawaharlal Nehru Medical College 
Address  Dept of Physiology, J.N.Medical College,Nehru Nagar Belagavi karnataka- 590010
J.N.Medical College, KLE University, Nehru Nagar Belagavi karnataka- 590010
Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax  0831-2470759  
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Public Query  
Name  Dr Harpreet Kour 
Designation  Prncipal investigator 
Affiliation  JNMC, KLE University 
Address  Dept of Physiology, J.N.Medical College,Nehru Nagar Belagavi karnataka- 590010
.N.Medical College, KLE University, Nehru Nagar Belagavi karnataka- 590010
Belgaum
KARNATAKA
590010
India 
Phone  9620850326  
Fax  0831-2470759  
Email  harpreet.kour@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. RamalingaswamiBhawan, Ansari Nagar, P.Box No. 4911 New Delhi – 110029  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harpreet Kour  Dr Prabhakar Kore Hospital and Medical Researach Centre,OPD No.11 . Dept of General Medicne  OPD No 11, Department of General Medicine
Belgaum
KARNATAKA 		 9620850326
0831-2470759
harpreet.kour@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients newly Diagnosed with T2DM, aged 20-45 years,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1. Diabetic Controls 2. Normal Healthy Controls  1. Newly Diagnosed T2DM patients- randomly divided into diabetic and intervention group 2. Sex, age and mean education matched Normal Healthy Controls  
Intervention  Exercise Therapy  Six months of intervention therapy was administered after obtaining baseline parameters exercise program of regular exercise consisting of aerobic and resistance exercises. The aerobic exercise is 30 min of activity 5 days/week,(ADA Guidelines)duration at an intensity of 70–80% of their individualized maximum heart rate and with no gap of more than 2 consecutive days without physical activity. Resistance exercise performed 3 times a week targeting all major muscle groups, progress to 3 sets of 8-10 repetitions at a weight that can’t be lifted more than 8-10 times. All patients were provided with detailed instruction booklets describing each resistance training exercise and appropriate equipment’s (dumbbells) to perform resistance training. Participants were also instructed to complete weekly training diaries and were instructed to attend the research laboratory weekly once to perform the home-based training so that technique and progression could be monitored. Anthropometric, Cardiovascular, Physiological, Biochemical and Cognitive Parameters were assesed 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  i. All the patients diagnosed newly with T2DM (Jan. 2013- Jan 2014)
ii. Age group 20-40 years.
iii. Patients treated with only diet and oral anti-diabetics.
iv. Subjects who, based on their medically assessed health status and physical characteristic, will be enrolled to perform a physical training program designed with ADA guidelines.
v. Minimum educational qualification up to fifth year of schooling.
vi. Patients who can read and write Kannada or Marathi or Hindi or English.
vii. Patients who will be willing to be enrolled for the study and who will give the written informed consent after receiving information about the study objective.
 
 
ExclusionCriteria 
Details  i. Subject with history of Diabetes more than a year.
ii. Known vascular complication of diabetes, such as coronary artery disease, stroke, nephropathy, retinopathy, and polyneuropathy which, in the investigators judgment, may have comprised the physical integrity of the patient.
iii. Other chronic diseases restricting physical activity.
iv. With peripheral Vascular Diseases.
v. Smokers and Alcoholics.
vi. Any psychiatric history
vii. Juvenile Diabetes
viii. Subjects with prior regimen of physical exercise
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anthropometric, Nerve conduction velocity, Vo2 max, Lipid profile, Glucose Profile, Attention and concentration, immediate recall, delayed recall, verbal retention for dissimilar pairs, visual retention, audio-visual reaction time, intelligence, psycho motor function, and executive functions improved consistently and significantly, exhibiting secular trends.  1. At Baseline
2. At the end of 2 months
3. At the end of 4 months
4. At the end of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. to study short term effects of structured exercise therapy
2. To compare among three groups 		 At 2nd and 4 months 
 
Target Sample Size   Total Sample Size="148"
Sample Size from India="148" 
Final Enrollment numbers achieved (Total)= "148"
Final Enrollment numbers achieved (India)="148" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2014 
Date of Study Completion (India) 04/05/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Harpreet Kour, V.A.Kothivale, Shivaprasad S.Goudar. Short-term effects of structured exercise therapy on memory of adult patients newly diagnosed with type 2 diabetes mellitus. Indian Journal of Clinical Anatomy and Physiology, January – March, 2(1), 31-36. Harpreet Kour, V.A.Kothivale, Shivaprasad S.Goudar. Study to evaluate the effects of Short term structured exercise therapy on Neurophysiological parameters in adults with newly diagnosed Type 2 Diabetes Mellitus - A Randomized Controlled Trial. Journal of Diabetes and Health. Photon 108 (2015) 236-242  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The prevalence of diabetes is rapidly rising all over the globe at an alarming rate due to population growth, aging, urbanization and an increase of obesity and physical inactivity. A less addressed and not as well recognized complication of diabetes is cognitive dysfunction. Patients with diabetes mellitus have been found to have cognitive deficits that can be attributed to their disease. Both hypoglycemia and hyperglycemia have been implicated as causes of cognitive dysfunction. Mild to moderate impairments of cognitive functioning has been reported both in patients with T1DM with T2DM. Exercise has been considered a cornerstone of diabetes management, along with diet and medication. In virtually all populations, higher fat diets and decreased physical activity and sedentary occupational habits have accompanied the process of modernization which has resulted in the doubling of the prevalence of obesity and T2DM in less than a generation. A less addressed and not as well recognized complication of diabetes is cognitive dysfunction. Patients with diabetes mellitus have been found to have cognitive deficits that can be attributed to their disease. Both hypoglycemia and hyperglycemia have been implicated as causes of cognitive dysfunction .Mild to moderate impairments of cognitive functioning has been reported both in patients with T1DM with T2DM Although much research has been done, the pathophysiology underlying this complication is not well understood, and the most appropriate methods to diagnose, treat, and prevent cognitive dysfunction in diabetes have not yet been defined.

Exercise has been considered a cornerstone of diabetes management, along with diet and medication. However, high-quality evidence on the importance of exercise and fitness in diabetes was lacking until recent years. The benefits of exercise in preventing and treating diabetes are widely recognized. Exercise improves glycemic control, body composition, cardiorespiratory fitness, cardiovascular risk, physical functioning and well-being in patients with T2DM but its effect on neurocognitive behavior is still not clear.

Justification of the study (Novelty):

 

It is well known from the literature that neurophysiological and cognitive disturbances are also one of the complications of diabetes mellitus. Although studies have shown that exercise enhances cognitive abilities in normal individuals. Previous studies have found improvement in cognitive dysfunctions in older T2DM patients with exercise regimens but unable to conclude.

The previous investigations were limited to relatively homogenous population, single measure of cognitive function and short follow up times. There is almost no evidence regarding the effect of exercise on neurocognitive function in young adult T2DM.

Targeting young T2DM patients with exercise therapy may delay the onset and complication of cognitive disorders and provide them with a better quality of life.No study exists on effect of exercise therapy on neurophysiological parameters which are of prime importance.Therefore this study is undertaken to evaluate the effect of exercise therapy in T2DM patients of age group 20-45years with neurophysiological and cognitive decline.

 

Research problem:

Effect of exercise on physiological and neurocognition in young adults with type 2 Diabetes mellitus

 

Objectives: To evaluate the effects of structured exercise therapy on cognitive performance and neurophysiological functions in young adults with T2DM.

 

Importance of the Research and applicability: The proposed work is significant on an important wide spreading non-communicable disease incapacitating in India i.e T2DM due to life style modifications. It is innovative in its concept of evaluating the effect of structured exercise therapy on cognitive performance and neurophysiological parameters in young adults with T2DM.

Expected benefits: It is hypothesized that exercise therapy along with dietary control and anti-diabetic medication will have a positive influence on neurocognitive and physiological functions compared to counseling for exercise, diet control and anti- diabetic agents. And the low cost, non-pharmacological nature of exercise will further enhance its therapeutic appeal.

 Benefits:Targeting young T2DM patients with exercise therapy may delay the onset and complication of cognitive disorders and provide them with a better quality of life. The results of this trial will provide novel data to indicate whether exercise improves cognition for a vulnerable group of young adults , and  if proves then will set the stage for larger trials to further examine potential protective and disease modifying effects of exercise therapy. Also if trail show positive results, it may result including recommendations of personalized exercise regimen in management of T2DM.

 

 Methodology:

Source of Data: Patients enrolled in year 2013-14 from Dept. of medicine, KLE’s DrPrabhakarKore Hospital and Research Centre.

Study Design: An Interventional randomized control trial.  (Pre-post Design)      

Sample Size: The patients aged 20-45 years who were eligible as per the inclusion criteria were enrolled at the time of data collection from the medicine department of KLE hospital. Sample size was calculated by using statistical methods.

The sample was divided into two groups by randomization(Randomization done by by computer generated, randomized number sequence, will be placed in  Opaque Sealed Envelopes) into diabetic control group (on medication and diet plan),  Interventional group (medications, diet plan and structured exercise therapy). The Normal control group (Healthy Individuals) was taken as third group.

Study Parameters: Socio-Demographic variables, Cardiovascular Variables, Biochemical Parameters, Physiological Parameters and cognitive parameters.

 

Statistical analysis:

Protection of Human Subjects: The study protocol has been approved by Institutional Ethical Board.

Procedures: Neurocognitive functions  evaluated include remote memory, recent memory, mental balance, attention and concentration, delayed recall, immediate recall, verbal retention for similar pairs, verbal retention for dissimilar pairs, visual retention and recognition by PGI memory analysis scale, intelligence by Bhatia’s Battery of performance test of intelligence, organic brain pathology by Nahor Benson test and visual acuity and motor functioning Bender Visual Motor Gestalt test.

The Physiological and Biochemical functions assessed were Blood sugar levels, Glycated hemoglobin, Hemoglobin%, Lipid Profile, VO2 max., Skin fold thickness, Waist circumference, Hip circumference, BMI, , Audio-Visual reaction time, Blood Pressure Recording, and Nerve Conduction Velocity Test.

Statistical analysis: Distributions of variables and their goodness of fit is studied and tested.To test the difference between means Z Test and Analysis of Variance (ANOVA) wase used.In case of proportions Z Test, Chi-square test and non- parametric test as required ise used.Multiple Regression Analysis and Logistic Regression Analysis as required will be used to study the impact of individual variables and their interactions.

 Results: Consistently increasing secular trends in outcome parameters.

 

Duration of the project: 2 years  
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