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CTRI Number  CTRI/2024/01/061956 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 22/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   In type 2 diabetes mellitus the cognitive motor dual task blindfold training is crucial to stimulate the cognitive neural network and facilitate various sensory receptors in body where helps in improving cognitive function of patients. 
Scientific Title of Study   Effects of cognitive motor dual task training with blindfold on cognition in type 2 diabetes mellitus - A Randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  J Anandh Raj 
Designation  Assistant Professor 
Affiliation  Apollo Institute of Medical Science and Research. 
Address  Apollo college of Physiotherapy, 1st floor near library lobby, Apollo Institute of Medical Science and Research, Murakambattu, Chittoor, Chittoor District, Andhra Pradesh - 517127, India.

Chittoor
ANDHRA PRADESH
517127
India 
Phone  9100230011  
Fax    
Email  j.anandhraj2246@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ramesh Chandra Patra 
Designation  Assistant Professor 
Affiliation  Lovely Professional University 
Address  Room no. 210, 2nd floor, Block no 3, School of Health Sciences, Lovely professional University, jalandhar-

Jalandhar
PUNJAB
144411
India 
Phone  7009769587  
Fax    
Email  rameshpatra2208@gmail.com  
 
Details of Contact Person
Public Query
 
Name  J Anandh Raj 
Designation  Assistant Professor 
Affiliation  Apollo College Physiotherapy, Apollo Institute of Medical Science and Research. 
Address  Apollo College of Physiotherapy, 1st floor near library lobby, Apollo Institute of Medical Science and Research, Murakambattu, Chittoor, Chittoor District - 517127, Andhra pradesh - 517127, India

Chittoor
ANDHRA PRADESH
517127
India 
Phone  9100230011  
Fax    
Email  j.anandhraj2246@gmail.com  
 
Source of Monetary or Material Support  
Apollo College of Physiotherapy, Apollo Institute of Medical Science and Research, Chittoor- 517127, Andhra Pradesh, India. 
Apollo District head Quarter hospital, AIMSR, Chittoor, AP, India 
Dr. Ramesh Chandra Patra, Faculty of Allied Health Sciences, Lovely Professional University 
 
Primary Sponsor  
Name  J Anandh Raj 
Address  Apollo College of Physiotherapy, AIMSR, Chittoor - 517127, Andhra Pradesh, India. 
Type of Sponsor  Other [Self] 
 
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 Raja Sekhar  Chittoor District Head Quarters Hospital, Apollo Institute of Medical Science and Research.  Room no 31, Physio OPD, Apollo Chittoor District Head Quarters Hospital, Apollo institute of medical sciences and research, Chittoor-517001, Andhra Pradesh, India
Chittoor
ANDHRA PRADESH 
9989252509

rajasekhar8817@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Apollo institute of medical sciences and research, chittoor.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive Motor Dual-task Training along with aerobic and resistance training.  3 sessions per week for 12 consecutive weeks. 
Intervention  Cognitive Motor Dual-Task Training with Blindfold along with aerobic and resistance training.  3 sessions per week for 12 consecutive weeks. 
Comparator Agent  Conventional therapy of aerobic and resistance training  3 sessions per week for 12 consecutive weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Diagnosis of T2DM > 5years confirmed by the physician;
2. Age between 40 to 70 year: either gender;
3. HbA1C level : above 6.5 mmol/dL
4. Education level more than 5 years
5. Sufficient cognitive level for understanding and agreement to participate in the study  
 
ExclusionCriteria 
Details  1. Mini- Mental State Examination [MMSE] score less than 24;
2. Diagnosis of progressive neurological disease;
3. Limited mobility;
4. Diagnosis of cardiovascular disorder;
5. Diagnosis of microvascular and macrovascular complications and symptom of diabetic neuropathy;
6. Occurrence of skin lesion or local infection over the dorsiflexor and plantar flexor muscle;
7. History of skeletal muscle injury in previous six months or during the execution of the study;
8. Inability to undergo evaluations in a satisfactory manner;
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cognitive function  12 week
& 18th week follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Association of HbA1c level
Muscle strength
Body mass index 
12 week
& 18th week follow up 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) 30/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Type 2 diabetes mellitus is one most major health burden for the elderly population, affecting approximately 25% of people over the age of 65 years. Beyond microvascular and macrovascular complications, cognitive decline has been described as a new diabetes complication in the elderly population. Increased level of attention has been paid by researchers and clinicians to this age-related condition— which is characterized by loss of dual task activity together with loss of cognitive function—in individuals with T2DM; this is due to the heavy impact that cognitive decline may have on physical and psychosocial health of diabetic patients, thus affecting their quality of life. The main aim of the Randomised controlled trial (RCT) to determine the effect of cognitive motor dual task training with and without blindfold exercise on cognition in people with T2DM. We hypothesized that here will be significant difference in the effects of cognitive motor dual task blindfold training, cognitive motor dual task training and conventional therapy on cognition in type 2 diabetes mellitus.

Methods: A randomized controlled and parallel three arm trial with patient blinded. A total of  93 patients with type 2 diabetes mellitus aged 40-65 either gender with HbA1c > 6.6 mmol/dL and more than 5 years of education. The eligible subjects will undergo for baseline assessment of BMI, Muscle strength, duration of disease. Then the subjects will be allocated to each group through random lottery method. After allocation the subjects in the experimental group A group will receive CMDBT, experimental group B group will receive CMDT and control group will receive conventional therapy of aerobic and resistance training 3 sessions / week for 12 consecutive weeks. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes.  The primary outcome measures are Montreal cognitive assessment and Trail making test.

Discussion: This research study focuses mainly on the cognitive function. In order to ensure the quality of the experiment, this study gives the treatment plan in detail and establishes a unified framework. Later results analysis will be done, this study believes that this cognitive motor dual task training with blindfold will effectively help to improve cognitive function in type 2 diabetes mellitus subjects.

 

Key words: Type 2 Diabetes mellitus, Cognitive function, Cognitive motor dual task training, Cognitive decline and Blind fold training. 
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