| 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 |
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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 |
|
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Source of Monetary or Material Support
|
| Jamia Hamdard, Mehrauli Badarpur road, Hamdard nagar, New delhi, 110062, India |
|
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Primary Sponsor
|
| Name |
Jamia hamdard University |
| Address |
M.B road,Hamdard nagar , 110062 |
| Type of Sponsor |
Other [University] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
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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. |
|
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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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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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 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Inflammatory Markers
Smoking Status
Medication Use (Diabetes, BP)
Baseline Physical Activity
Blood Pressure (BP)
|
At baseline and at 12 Weeks |
|
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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
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|
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%, respectively. Exercise 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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