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

Not Applicable

• Conditions: Sarcopenia
• Interventions: Behavioral: nutritional intervention; Behavioral: resistance training program; Behavioral: lifestyle modification project; Behavioral: control

• Registration Number: NCT02873676
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-16
• Study Start: 2016-03
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-13
• Last Update Posted: 2020-06-16
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutritional intervention	nutritional intervention	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).
resistance training program	resistance training program	This group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing.
lifestyle modification project	lifestyle modification project	This group receive multi-dimensional intensive nutritional intervention and resistance training program.
control	control	This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization.

Primary Outcome Measures

Name	Time	Method
relative skeletal muscle index	3 months	RSMI(Unit: kg/m2)is defined as muscle mass

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China