Prevalence and Effect of Lifestyle Modification on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia

Study Overview
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Brief Summary
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The purposes of this study were to investigate the prevalence and risk factors for sarcopenia in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification Project (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.

Official Title
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Prevalence and the Effect of Lifestyle Modification Project (LMP) on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia in Chinese Adults and Elderly: a Multicenter Randomized Controlled Trail

Conditions
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Sarcopenia

Intervention / Treatment
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* Behavioral: nutritional intervention
* Behavioral: resistance training program
* Behavioral: lifestyle modification project
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent Exclusion Criteria: age<18 year Concurrent severe cardiac disease, unstable diabetes mellitus,uncontrolled chronic disease,liver and renal failer, which may significantly interfere with study compliance. Participants received any drugs or supplements known to influence effcet size,such as protein powder, calcium, or vitamin D before the 3 months preceding the study. Participants with electronic or mental device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional intervention<br>This group received multi-dimensional intensive nutritional intervention for 3 month, which included whey (30g/d,plus three times every week ),vitamin D (1000IU) and omega-3 fatty acid (DHA 1200mg and EPA 800mg). | Behavioral: nutritional intervention<br>* The intervention is made up of nutrition supplements and dietary pattern modification, which includes whey 30g/d(plus three times every week),vitamin D 1000IU, omega-3 fatty acid (DHA1200mg and EPA 800mg)<br>|
| Experimental: resistance training program<br>This group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing. | Behavioral: resistance training program<br>* The training program involve warm-up exercise, muscle strength training and relaxing<br>|
| Experimental: lifestyle modification project<br>This group receive multi-dimensional intensive nutritional intervention and resistance training program. | Behavioral: lifestyle modification project<br>* Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training<br>|
| Placebo Comparator: control<br>This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization. | Behavioral: control<br>* The intervention involve dietary pattern modification and protein intake standardization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative skeletal muscle index | RSMI(Unit: kg/m2)is defined as muscle mass | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip | HG(Unit: kg)is defined as muscle strength | 3 months | 
| gait speed | GP(Unit: s)is defined as physical activity level | 3 months | 
| quality of life on EQ-5D scale | Scores range from 0 [worse] to 1[best](Unit on a scale) | 3 months | 
| The rate of fracture | rate of participants with fracture due to fall(Unit: %) | 3 months | 
| the change of physical function on frail index | Scores range from 0 [normal] to 1[unhealth](Unit on a scale) | 3 months | 
| the rate of infection complication | Rate of participants with infection complication due to sarcopenia(Unit: %) | 3 months | 
| mortality rate | Rate of participants mortality(Unit: %) | 3 months | 
| medical cost on cost-effectiveness ratio | the lower cost，the higher effectiveness(Unit: %) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevalence; lifestyle modification; clinical outcomes