| 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
|
|
|
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
|
|
|
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. |