Study of the effect of exercises and diet on bone and muscles in obese patients with osteosarcopenia

Not yet recruiting

• Conditions: Obesity, unspecified,

• Registration Number: CTRI/2022/07/044121
• Lead Sponsor: Indian Council of Medical Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-08
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Age 30-60 years -BMI≥25 Kg/m2 -Willing to give consent to participate in the study.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 West, DELHI, India

AIIMS, New Delhi

🇮🇳West, DELHI, India

Dr Ranveer Singh Jadon

Principal investigator

9540951048

rsjadonaiims@gmail.com