Prevalence and Effect of Lifestyle Modification on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia
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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 16, 2020
June 1, 2020
4.8 years
September 16, 2015
June 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
relative skeletal muscle index
RSMI(Unit: kg/m2)is defined as muscle mass
3 months
Secondary Outcomes (8)
Hand grip
3 months
gait speed
3 months
quality of life on EQ-5D scale
3 months
The rate of fracture
3 months
the change of physical function on frail index
3 months
- +3 more secondary outcomes
Study Arms (4)
nutritional intervention
EXPERIMENTALThis 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
EXPERIMENTALThis group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing.
lifestyle modification project
EXPERIMENTALThis group receive multi-dimensional intensive nutritional intervention and resistance training program.
control
PLACEBO COMPARATORThis group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization.
Interventions
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)
The training program involve warm-up exercise, muscle strength training and relaxing
Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training
The intervention involve dietary pattern modification and protein intake standardization
Eligibility Criteria
You may qualify if:
- age\>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, China
Related Publications (3)
Li CW, Li Q, Liu Y, Zhang Y, Wang ZK, Xing Y, Niu YS, Pang Y, Yu K. Sarcopenic obesity exacerbates gastric cancer prognosis via increased intermuscular and visceral fat accumulation. Eur J Med Res. 2025 Oct 22;30(1):1012. doi: 10.1186/s40001-025-03251-6.
PMID: 41126316DERIVEDLi Z, Cui M, Yu K, Zhang XW, Li CW, Nie XD, Wang F. Effects of nutrition supplementation and physical exercise on muscle mass, muscle strength and fat mass among sarcopenic elderly: a randomized controlled trial. Appl Physiol Nutr Metab. 2021 May;46(5):494-500. doi: 10.1139/apnm-2020-0643. Epub 2020 Nov 20.
PMID: 33216623DERIVEDLi CW, Yu K, Shyh-Chang N, Li GX, Jiang LJ, Yu SL, Xu LY, Liu RJ, Guo ZJ, Xie HY, Li RR, Ying J, Li K, Li DJ. Circulating factors associated with sarcopenia during ageing and after intensive lifestyle intervention. J Cachexia Sarcopenia Muscle. 2019 Jun;10(3):586-600. doi: 10.1002/jcsm.12417. Epub 2019 Apr 10.
PMID: 30969486DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kang Yu
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2015
First Posted
August 19, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06