| CTRI Number |
CTRI/2024/02/062765 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Exercise on Age related muscle weakness among People with Type 2 diabetes mellitus |
|
Scientific Title of Study
|
Effect of Exercise-based Intervention on Mitochondrial Dysfunction in Type 2 Diabetes Mellitus with Sarcopenia- A Randomized Controlled 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 |
Deeksha Shettigar |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Center for Podiatry and Diabetic Foot Care and Research Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9620886655 |
| Fax |
|
| Email |
dee.shettigar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deeksha Shettigar |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Center for Podiatry and Diabetic Foot Care and Research Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9620886655 |
| Fax |
|
| Email |
dee.shettigar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Chief Center for Podiatry and Diabetic Foot Care and Research Dean MCHP Professor |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education Manipal |
| Address |
Center for Podiatry and Diabetic Foot Care and Research Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
ajmaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR Extramural Research Programme Investigator Initiated Projects Intermediate grant
Dr Pulkit Verma Scientist C Division of BMI ICMR Headquarters New Delhi 110029
|
|
|
Primary Sponsor
|
| Name |
ICMR Extramural Research Programme Investigator Initiated Projects Intermediate Grant |
| Address |
Dr Pulkit Verma Scientist C Division of BMI ICMR Headquarters New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Deeksha Shettigar |
Kasturba Hospital Manipal |
Kasturba Hospital Room No. 4 Center for Podiatry and Diabetic Foot Care and Research Department of Physiotherapy First Floor N Block Manipal Karnataka 576104
Udupi
KARNATAKA |
9620886655
dee.shettigar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise-based Intervention |
Exercise-based intervention will be administered for 12 weeks which will mainly target on muscle strength, muscle mass and improving quality of life.
It consists of Resistance training, Aerobic exercise and Balance exercise. Exercises will be progressed as per the resistance, and repetition in the 4th and 8th week. |
| Comparator Agent |
Standard care |
Participants in the control group will be instructed to continue their activities of daily living and maintain standard care given by physician |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 40-70 years
Individuals diagnosed with T2DM and on medication
SARC-F score more than or equal to 4
Less than 600 MET minutes per week |
|
| ExclusionCriteria |
| Details |
History of lower limb amputation and lower limb injury
Active lower limb ulcer
Neuromuscular pathology
Any Neurodegenerative diseases
Any Cardiac disorders
Patients diagnosed with Cancer
Systemic illness which hinders participation in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SARC F Questionairre
Hand Grip Strength using Jamar Hand held Hydraulic Dynamometer
Quadriceps and Calf muscle circumference using Inch tape
Skeletal mass index using BIA- Inbody 270 |
Baseline
12th week of intervention
24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscle ultrasound imaging of Quadriceps and Calf muscles
Blood Biomarkers
Timed Up and Go test |
Baseline
12th week of intervention
24th week |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Evaluating the effect of Exercise-based intervention in Type 2 Diabetes mellitus(T2DM) with Sarcopenia on Skeletal mass index, SARC-F, Hand grip strength, Limb girth of Quadriceps and Calf muscle, Physical performance using Timed-up and Go test and few blood biomarkers and ultrasound imaging of quadriceps and calf muscle.Patients with T2DM and Sarcopenia coming to the Center for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, and Department of Endocrinology, Kasturba Hospital Manipal will be thoroughly screened in accordance with the inclusion and exclusion criteria and will be included in the study. Each participant will be informed in detail about the study and the participant information sheet (PIS) along with an informed consent form will be provided to them. If they agree to take part in the study, We will get their written informed permission. The participants will be screened for Sarcopenia using the SARC-F questionnaire and Calf Circumference measurement will be done. A GPAQ questionnaire will be used to assess the Physical activity level. Demographic details and detailed clinical evaluation of the study participants will be done. The baseline primary and secondary outcome measures SARC- F questionnaire, Hand grip strength, Limb girth assessment of Quadriceps and calf muscle, Skeletal mass index, blood biomarkers, ultrasound imaging to observe the soft tissue changes of Quadriceps and calf muscles, and Timed up and go test will be evaluated at the time of the initial visit along with the demographic details of each participant. Once the patient completes all the baseline assessments, Individuals will be randomized into Interventional and Control groups with a computer-generated varied blocked randomization method. The allocation will be conducted with the sealed envelope method, the sequence will be written in paper which will be put inside an envelope and will be opened by an assistant at the time of each recruitment. Exercise-based intervention protocol will be explained to each participant and the first session will be conducted under the supervision of the primary investigator. Exercise-based intervention involves Resistance exercise, Aerobic training, and Balance training exercises. Exercises will be for 12 weeks. These exercises will be progressed as per the resistance, and repetition in the 4th and 8th week. Supervised exercise sessions will be planned every two weeks. Participants in the control group will be instructed to continue their activities of daily living as usual and also Maintain standard care by the physician. All the outcome measures will be assessed at the baseline, the 12th week of treatment, and at the 24th week(Follow-up). The participant has to visit the hospital 3 times.
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