| 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
|
|
|
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
|
|
|
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. |