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CTRI Number  CTRI/2024/02/063021 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Connection between Muscle loss 6- minute walking test and general well-being in Diabetic patients above 50 years. 
Scientific Title of Study   Relationship between Sarcopenia 6-Minute walk test and Quality of Life in Diabetic patients aged over 50 years- Pilot study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swetha Jennifer S 
Designation  Student 
Affiliation  St Johns Medical College 
Address  Department of Physiotherapy St Johns Medical College Sarjapur Road Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8792611656  
Fax    
Email  swethajennifer0818sk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  A Sankarganesh 
Designation  Associate professor 
Affiliation  St Johns Medical College 
Address  Department of Physiotherapy St Johns Medical College Hospital Sarjapur Road Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8925080987  
Fax    
Email  a.shankarganesh87@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swetha Jennifer S 
Designation  Student 
Affiliation  St Johns Medical College 
Address  Department of Physiotherapy St Johns Medical College Sarjapur Road Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8792611656  
Fax    
Email  swethajennifer0818sk@gmail.com  
 
Source of Monetary or Material Support  
St Johns Medical College Hospital 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  Rajiv Gandhi University of Health Sciences 12, 30th Cross Rd, opp. Sagar Hospital, 4th T Block East, Pattabhirama Nagar, Jayanagar, Bengaluru, Karnataka 560041 
Type of Sponsor  Government medical college 
 
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 
Swetha Jennifer S  St. Johns Medical College Hospital  Department of Radiology, Room no:55(Ground floor) and Department of Physiotherapy, Room no:66(Ground floor). St. Johns Medical Hospital, John Nagar, Sarjapur road Bengaluru-560034
Bangalore
KARNATAKA 
8792611656

swethajennifer0818sk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Type 2- Diabetic patients 
 
ExclusionCriteria 
Details  Chronic cardiac condition.
Neurological Impairments.
Musculoskeletal Deformities.
Non cooperative Participants. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate the correlation between Glycemic control and Sarcopenia among Diabetic patients aged over 50 years  At the end of the 1st session. 
 
Secondary Outcome  
Outcome  TimePoints 
To find the relationship between sarcopenia and 6-minute walk test(6-MWT) in Diabetic patients  At the end of the 1st session.  
To find Quality of life in Diabetic patients with Sarcopenia.  At the end of the 1st session. 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) 31/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Aim: To find the relationship between Sarcopenia, 6-Minute walk test (6-MWT) and Quality of life in Diabetic patients aged over 50 years.

The incidence and Prevalence of metabolic and musculoskeletal diseases are increasing. In which Type 2-DM accounts for around 90% of all cases. It is a complex heterogenous metabolic disorder and causes dysfunction in multiple organs and tissues. Type 2 Diabetes is a highly prevalent health problem in the elderly, affecting  >25% of people aged  > 65 years. Older adults with Diabetes are known to have higher rate of functional decline and disability. Now, Sarcopenia is recognized as another co-morbidity in older adults with Diabetes. Diabetes as been reported to accelerate the reduction of muscle mass and strength by several mechanisms like protein synthesis is stimulated by insulin and impairment in the insulin-associated signaling pathway might lead to reduced muscle anabolism and increased protein catabolism, which contribute to sarcopenia.

Sarcopenia is defined as a syndrome of progressive and generalized loss of skeletal mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death  by the European Working Group on Sarcopenia in older people (EWGSOP). The three core criteria are low muscle mass, low muscle strength and poor physical performance.

The gold standard methods for assessing the muscle mass are CT, MRI and DEXA which can assess the skeletal muscle mass accurately. However, these assessments cannot be performed frequently because of the radiation exposure and complexity. Ultrasonography is a rapid, affordable and a non-invasive technique that is widely available. It is a promising technique for estimating the skeletal muscle mass, quality and architecture and thus possibly useful for diagnosing or screening Sarcopenia. 6-MWT is a measure of physical fitness, a submaximal test to assess the aerobic capacity and endurance. The strength of the muscle is assessed by 1-Repetition maximum (RM) which is a gold standard method for assessing the strength capacity in the Non-laboratory settings.

In this study we will be looking at the Quadriceps Femoris muscle for which the 1-RM will be assessed and the Ultrasound of the same will be taken. Girth measurement of Quadriceps femoris and Calf muscle, Hand Grip strength of the forearm muscles will be assessed. The HbA1c value will be collected from the participants. 6-MWT will be performed and participants will be asked to fill in SARC-F and SarQoL Questionnaire.

Proper evidence based studies are not done to find the relationship between sarcopenia, 6-MWT and Quality of life in Diabetic patients, thus by this study we can develop an effective, easily accessible and safe assessment pattern to determine the exercise capacity and use those results to prescribe  exercise. 
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