| CTRI Number |
CTRI/2019/06/019941 [Registered on: 28/06/2019] Trial Registered Prospectively |
| Last Modified On: |
22/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercise, nutrition and muscle quality |
|
Scientific Title of Study
|
Randomized controlled trial to compare the impact of exercise and nutritional interventions on changes in skeletal muscle mass and function in obese patients with sarcopenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naval K Vikram |
| Designation |
Professor |
| Affiliation |
A.I.I.M.S., New Delhi |
| Address |
Department of Medicine, 3rd Floor Room No 8, A.I.I.M.S,
South
DELHI
110029
India |
| Phone |
119810007331 |
| Fax |
01126588663 |
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naval K Vikram |
| Designation |
Professor |
| Affiliation |
A.I.I.M.S., New Delhi |
| Address |
Department of Medicine, 3rd Floor Room No 8, A.I.I.M.S,
South
DELHI
110029
India |
| Phone |
119810007331 |
| Fax |
01126588663 |
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naval K Vikram |
| Designation |
Professor |
| Affiliation |
A.I.I.M.S., New Delhi |
| Address |
Department of Medicine, 3rd Floor Room No 8, A.I.I.M.S,
South
DELHI
110029
India |
| Phone |
119810007331 |
| Fax |
01126588663 |
| Email |
navalvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V Ramalingaswami Bhawan, PO Box No 4911 Ansari Nagar New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Submitted to ICMR |
| Address |
Indian Council of Medical Research, Ansari Nagar, Post Box 4911, New Delhi-110029 |
| 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 Naval K Vikram |
All India Institute of Medical Sciences. new Delhi |
Department of Medicine, 3rd Floor, Cross Wing Room No 8
South
DELHI |
119810007331
01126588663
navalvikram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, A.I.I.M.S., New Delhi |
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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Progressive resistance exercise |
Progressive resistance exercise with nutritional intervention for a period of 6 months |
| Comparator Agent |
Standard physical activity |
Standard physical activity with nutritional intervention for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between 30-60 years of age with BMI ≥25 kg/m2, diagnosed to have sarcopenia based on the following definition of sarcopenia:
1 Appendicular skeletal muscle mass/height2: Men< 7.0 kg/m2, Women <6.0 kg/m2.
2 Hand grip strength Men: <27 kg Women: <16 kg
3 SPPB ≤8 (The maximum score on the SPPB is 12)
4 4-minute gait speed < 0.8 m/s
|
|
| ExclusionCriteria |
| Details |
1 Known or recently diagnosed diabetes mellitus or coronary heart disease
2 Contraindication to aerobic exercise or progressive resistance training
3 Any severe acute or chronic illness, severe end organ dysfunction, post organ transplant
4 Known malignancy, HIV/ HBsAg/Anti HCV positivity
5 Chronic alcohol use (>30 g/day in men and >20 g/day in women) or any other drug abuse
6 Use of any medications that may affect the muscle function or mass such as corticosteroids, anabolic steroids, protein supplements, performance enhancing medications etc.
7 Pregnancy and lactation, any physical deformity or loss of extremity
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in muscle mass and function in sarcopenic individuals |
At the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in metabolic abnormalities such as insulin resistance, dyslipidemia and dysglycemia |
At the end of 6 months |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
26/08/2019 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Sarcopenia, an age related loss of skeletal muscle mass and function
is also seen in younger individuals and may lead to disability and future
complications. The trajectory of one’s muscle loss can be altered by physical
exercise and/or the environment, which are the modifiable risk factors.
Novelty: Indian population has been shown to have higher body fat and relatively
lower quality and quantity of skeletal muscle mass which may increase risk of sarcopenia.
This may contribute to the high prevalence of insulin resistance and its
complications. Effective interventions for sarcopenia are likely to have impact on
obesity and related metabolic problems. There is paucity of data in this regard
in Indian population.
Objectives: To compare the effect of nutritional intervention along with progressive
resistance training and nutritional intervention along with standard physical
activity on skeletal muscle mass and function, and metabolic parameters in
obese sarcopenic individuals.
Methods: This randomized controlled trial will include 140 obese patients with sarcopenia
divided into two intervention arms (nutritional intervention with resistance
exercise vs. nutritional interventions with standard exercise) for a period of
6 months. Anthropometry, biochemistry and muscle strength will be assessed at
baseline, 3 and 6 months. Whole body DEXA scan and plain CT scan at L3-4 level
for skeletal muscle area will be done at baseline and at 6 months.
Expected outcomes: Combination of nutritional intervention along with progressive
resistance training is likely to improve skeletal muscle mass and function in
obese sarcopenic individuals which may be helpful in designing appropriate
interventions for sarcopenia. |