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
|
|
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
|
|
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. |