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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873676
• Other study ID #: PUMCH344801
• Status: Recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu
• Phone: +86 10 69155550
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Behavioral:
• nutritional intervention
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)
• resistance training program
The training program involve warm-up exercise, muscle strength training and relaxing
• lifestyle modification project
Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training
• control
The intervention involve dietary pattern modification and protein intake standardization

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative skeletal muscle index	RSMI(Unit: kg/m2)is defined as muscle mass	3 months
Secondary	Hand grip	HG(Unit: kg)is defined as muscle strength	3 months
Secondary	gait speed	GP(Unit: s)is defined as physical activity level	3 months
Secondary	quality of life on EQ-5D scale	Scores range from 0 [worse] to 1[best](Unit on a scale)	3 months
Secondary	The rate of fracture	rate of participants with fracture due to fall(Unit: %)	3 months
Secondary	the change of physical function on frail index	Scores range from 0 [normal] to 1[unhealth](Unit on a scale)	3 months
Secondary	the rate of infection complication	Rate of participants with infection complication due to sarcopenia(Unit: %)	3 months
Secondary	mortality rate	Rate of participants mortality(Unit: %)	3 months
Secondary	medical cost on cost-effectiveness ratio	the lower cost,the higher effectiveness(Unit: %)	3 months