FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/044121 [Registered on: 19/07/2022] Trial Registered Prospectively
Last Modified On: 12/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of the effect of exercises and diet on bone and muscles in obese patients with osteosarcopenia 
Scientific Title of Study   Randomized control trial to study the impact of weight bearing and resistance exercise with nutritional interventions on bone and muscle health in obese patients with osteosarcopenia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranveer Singh Jadon 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-3070 A, 3rd Floor, Teaching Block, Department of Medicine, AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9540951048  
Fax    
Email  rsjadonaiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranveer Singh Jadon 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-3070 A, 3rd Floor, Teaching Block, AIIMS, Delhi 110029
Room no-3094 A, 3rd Floor, Teaching Block, AIIMS, Delhi
South West
DELHI
110029
India 
Phone  9540951048  
Fax    
Email  rsjadonaiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranveer Singh Jadon 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-3070 A, 3rd Floor, Teaching Block, AIIMS, Delhi 110029
Room no-3094 A, 3rd Floor, Teaching Block, AIIMS, Delhi
South West
DELHI
110029
India 
Phone  9540951048  
Fax    
Email  rsjadonaiims@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
Indian Council of Medical Research (ICMR)  
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Indian Council of Medical Research V Ramalingaswami Bhawan, PO Box No 4911 Ansari Nagar, New Delhi 110029, India Ph 91 11 26588895, 91 11 26588980 
Type of Sponsor  Government funding agency 
 
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 Ranveer Singh Jadon  AIIMS, New Delhi  R.no. 3070A, Teaching Block, Department of Medicine
South West
DELHI 
9540951048

rsjadonaiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard physical activity and nutritional intervention  Standard physical activity: A total of about 60 minutes of daily physical activity such as brisk walking, jogging etc will be advised. It will be advised to perform these exercises daily or at least five days in a week with a gradual progression in repetitions and intensity as tolerated by the patient for 6 months. Nutritional interventions (as in intervention arm): In the form of balanced diet advice with adequate protein and calcium intake as per standard dietary recommendations comprising up to 30% of total daily energy intake and appropriate intake of micronutrients for 6 months. A moderate energy restriction of 500 kcal/d will be advised targeted at a moderate weight loss of about 0.5 kg/wk or 8%–10% of initial body weight after 6 months.  
Intervention  Weight bearing and structured resistance exercises with nutritional intervention  Structured resistance exercise: Initially all the exercises will be demonstrated by a trained physiotherapist. Thera bands of different elastic strength (4 varieties) will be used and will be provided to all patients. In beginning a RET (resistance exercise therapy) program is to perform a ‘total body’ exercise routine whereby all of the major muscle groups i.e. chest, back, arms, shoulders, upper legs (quadriceps, hamstrings, and gluteal muscles), and lower legs (calves) are exercised. In each exercise session which is up to 90 minutes of duration, consist of maximum of 3 sets and in each set 10 repetitions of RET will be done as tolerated by the patients with gradual progression in supervision of a physiotherapist in initial one week, subsequently with the ‘total body’ routine being performed 3 times per week up to entire follow up of 6 months. Nutritional interventions: In the form of balanced diet advice with adequate protein and calcium intake as per standard dietary recommendations comprising up to 30% of total daily energy intake and appropriate intake of micronutrients. A moderate energy restriction of 500 kcal/d will be advised targeted at a moderate weight loss of about 0.5 kg/wk or 8%– 10% of initial body weight after 6 months. Weight bearing exercise program will be included in this group including bench press and double leg press, quarter squats up to right angle knee flexion, wide stance mini-squat, quadruped position and step-up exercises, wall slides with upper limb, and standing on one limb with arm support. Weight cuffs will be used as weight providing measures. These will be done 3 times/week for 6 months.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -Age 30-60 years
-BMI≥25 Kg/m2
-Willing to give consent to participate in the study
 
 
ExclusionCriteria 
Details  -Known or recently diagnosed diabetes mellitus (HbA1c≥6.5%) or coronary heart disease
-Contraindication to aerobic exercise or progressive resistance training
-Any severe acute or chronic illness, severe end organ dysfunction, post organ transplant
-Known malignancy, HIV/ HBsAg/Anti HCV positivity
-Chronic alcohol use (>30 g/day in men and >20 g/day in women) or any other drug abuse
-Use of any medications that may affect the muscle function or mass such as corticosteroids, anabolic steroids, protein supplements, performance enhancing medications etc.
-Pregnancy and lactation, any physical deformity or loss of extremity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Impact of combination of nutritional intervention along with progressive resistance training and weight bearing exercise on bone mineral density and muscle mass, strength and function in osteosarcopenic individuals  Muscle strength and function will be assessed at baseline, 3 months and at 6 months of intervention
Muscle mass and bone mineral density will be assessed at baseline and at 6 months of intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence and risk factors of osteosarcopenia among obese individuals.  Risk factors of osteosarcopenia will be assessed at baseline and prevalence will be assessed when desired number of osteosarcopenia patients will be recruited over 26 months. 
Effect of weight bearing and resistance exercise training and nutritional interventions on metabolic parameters, bone resorption and bone formation biomarkers in obese osteosarcopenic individuals  Assessment of metabolic parameters will be assessed at baseline, 3 month and at 6 month
Assessment of bone resorption and bone formation biomarkers will be done at baseline and at 6 month 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   01/08/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

1.      Osteosarcopenia is a relatively new entity that describes the co-existence of osteoporosis and sarcopenia which are associated with ageing. In addition to aging, osteosrcopenia is also associated with obesity. Osteosarcopenic obesity is a condition of growing importance with significant negative sequelae on both patients and society alike. Osteoporosis, a condition of low bone mass and mineralization of bone; sarcopenia, the loss of muscle mass, strength and function, and obesity, increased adipose tissue in body leading to significantly worsened outcomes than seen in either condition individually. For individuals, major consequences include falls and fractures, increased morbidity, mortality and disability, and reduced quality of life. For society, osteosarcopenia brings a staggering socioeconomic burden. With increasing age and obesity in population, osteosarcopenic obesity becomes a public health concern. Its aetiology is multi-factorial, with mechanical, biochemical, genetic and lifestyle factors all contributing to involution of the “bone-muscle- unit” and increasing adipose tissue. Increasing understanding of the interactions between muscle, bone and adipose tissue could facilitate the development of new therapeutic agents to mitigate the impact of these on individual’s health. Therefore, it is the urgent need of the hour for early diagnosis of osteosarcopenia in young obese population for effective therapeutic interventions. Together with existing pharmacological, nutritional and exercise-based therapies, the present proposal aim to provide non pharmacological management of osteosarcopenia using resistance exercise and nutritional intervention in osteosarcopenic obese patients.

 
Close