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CTRI Number  CTRI/2025/05/087951 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 19/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of multimodal exercise among Diabetic patients 
Scientific Title of Study   To Study the Effect of Multimodal Exercise on Body Composition, Physiological, and Biochemical Parameters among Diabetic subjects having Sarcopenia  
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr sohrab ahmad khan 
Designation  Professor 
Affiliation  Jamia Hamdard 
Address  Room Number 522, 5th floor , Central Library Building, Department of Physiotherapy, Jamia Hamdard, New Delhi

South
DELHI
110062
India 
Phone  8802648164  
Fax    
Email  sakhan_ahs@jamiahamdard.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Firdaus jawed 
Designation  Phd scholar 
Affiliation  Jamia Hamdard 
Address  Room Number 522, 5th floor , Central Library Building, Department of Physiotherapy, Jamia Hamdard, New Delhi

South
DELHI
110062
India 
Phone  9801381951  
Fax    
Email  firdauskhan3199@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr sohrab ahmad khan 
Designation  Professor 
Affiliation  Jamia Hamdard 
Address  Room Number 522, 5th floor , Central Library Building, Department of Physiotherapy, Jamia Hamdard, New Delhi

South
DELHI
110062
India 
Phone  8802648164  
Fax    
Email  sakhan_ahs@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
Jamia Hamdard, Mehrauli Badarpur road, Hamdard nagar, New delhi, 110062, India 
 
Primary Sponsor  
Name  Jamia hamdard University 
Address  M.B road,Hamdard nagar , 110062 
Type of Sponsor  Other [University] 
 
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 sohrab ahmad khan  Jamia Hamdard  Room Number 522, 5th floor , Central Library Building, Department of Physiotherapy, Jamia Hamdard, New Delhi
South
DELHI 
08802648164

sakhan_ahs@jamiahamdard.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Instituitional ethics Committee (JHIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patient will be added to a waitlist program. 
Intervention  Multimodal Exercise   The exercise prescription for this 6-week intervention consists of three 60-minute sessions per week on non-consecutive days, incorporating a multi-modal approach based on the recommendations in the guidelines of the American College of Sports Medicine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1-Adults aged 18-60 years diagnosed with Type 2 Diabetes Mellitus (T2DM)
2-Able to walk independently or with minimal assistance
3-No history of neurological disorders affecting cognition (e.g., stroke, Alzheimer’s)
4-Willing to provide informed consent
 
 
ExclusionCriteria 
Details  1. Individuals with severe mobility impairments preventing participation.
2. Diagnosed neurodegenerative diseases (e.g., dementia, Parkinson’s).
3. Uncontrolled psychiatric conditions.
4. Use of medications affecting muscle function or cognition.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Muscle Mass
Body Mass Index (BMI)
Waist-to-Hip Circumference Ratio
Physiological Parameters
Muscle Strength
Physical Performance
Balance
Heart Rate & Blood Pressure
Quality of Life
Sleep Quality
Biochemical Parameters
Glycemic Control (Hba1c)
Blood Glucose Levels
Lipid Profile
 
At baseline and at 12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Inflammatory Markers
Smoking Status
Medication Use (Diabetes, BP)
Baseline Physical Activity
Blood Pressure (BP)
 
At baseline and at 12 Weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   11/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Introduction

Sarcopenia is a significant public health concern, characterized by progressive loss of skeletal muscle mass, strength and function. It is one of the important functions for contributing to frailty, physical disability and increased risk of falls. Sarcopenia negatively impacts quality of life and poses substantial healthcare challenges. Its multifactorial etiology includes ageing, physical inactivity, chronic diseases, and nutritional deficiencies, making targeted interventions essential for prevention and management. With ageing, the amount of muscle cells is gradually depleted, and anabolic stimuli create resistance with a consequent decrease in mitochondrial function, changes in gene expression, reduced insulin sensitivity, and impaired neuromuscular signalling.

Diabetes has been associated with impaired insulin sensitivity and persistent systemic inflammation, which can increase the risk of sarcopenia. Globally, the prevalence of sarcopenia varies from 10% to 40%, contingent on evaluation standards and population variables. But according to recent meta-analyses, the prevalence of sarcopenia in diabetic patients is two to three times higher than in non-diabetic people. In India, the prevalence of sarcopenia, severe sarcopenia, and probable sarcopenia was 6.1%, 18.8%, and 43%, respectivelyExercise has emerged as a key component in the treatment of sarcopenia, with evidence supporting its function in increasing muscle mass, strength, and physical performance. While other modalities, such aerobic exercises and multimodal training regimens, have shown complimentary advantages, resistance training in particular has been thoroughly researched for its anabolic effects. Exercise is available to all, but nutrition is not feasible for most people. Nutrition alone cannot overcome the loss of muscle mass and it is not feasible for all. The expanding field of research has yielded diverse findings due to variations in study methodologies, participant demographics, intervention strategies, and outcome assessments. This inconsistency has made it challenging to establish clear-cut recommendations. While previous investigations have shown that consistent physical activity can enhance muscular performance and metabolic health across various groups, including those with chronic conditions, there remains a gap in our understanding. Specifically, we lack comprehensive knowledge about how structured exercise programs impact the physical and biochemical profiles of individuals with both sarcopenia and diabetes.

Objective

· Evaluate the effect of multimodal exercise on Body composition, Physiological, and Biochemical parameters among Sarcopenia Patients with Type 2 Diabetes.

Rationale

·       Sarcopenia, characterized by progressive loss of skeletal muscle mass and function, is increasingly recognized as a critical comorbidity in individuals with type 2 diabetes mellitus (T2DM), even among younger adults. The coexistence of these conditions amplifies the risk of physical disability, metabolic complications, and reduced quality of life, emphasizing the urgent need for effective, evidence-based interventions tailored to this population. While the prevalence and impact of sarcopenia have been extensively studied in older adults, there is a significant gap in research focusing on younger adults (20–50 years), despite evidence that early-onset sarcopenia in T2DM may accelerate disease progression and functional decline.

·       Multimodal exercise interventions-which combine resistance, aerobic, and balance training-have emerged as the most promising non-pharmacological strategies for improving muscle strength, physical function, and metabolic health in sarcopenic patients with T2DM. Meta-analyses and randomized controlled trials in older populations consistently demonstrate that such interventions lead to significant improvements in muscle strength (e.g., handgrip, leg strength), physical performance (e.g., sit-to-stand, timed up and go tests), and glycemic control (e.g., reductions in HbA1c). 


 
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