SarcopeniaNCT02873676
Prevalence and Effect of Lifestyle Modification on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia
A study testing nutritional intervention, resistance training program and lifestyle modification project in people with Sarcopenia, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- nutritional intervention, resistance training program and lifestyle modification project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Kang Yu, +86 13801130457, yuk1997@sina.com
About this study
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
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.
- Conditions
- Sarcopenia
- Being tested
- nutritional intervention, resistance training program, lifestyle modification project, control
- Keywords
- prevalence; lifestyle modification; clinical outcomes
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionBehavioural
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 programBehavioural
The training program involve warm-up exercise, muscle strength training and relaxing
lifestyle modification projectBehavioural
Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training
controlBehavioural
The intervention involve dietary pattern modification and protein intake standardization
| Study group | Role | What they receive |
|---|---|---|
| nutritional intervention | Experimental | 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). Receives: Behavioral: nutritional intervention |
| resistance training program | Experimental | This group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing. Receives: Behavioral: resistance training program |
| lifestyle modification project | Experimental | This group receive multi-dimensional intensive nutritional intervention and resistance training program. Receives: Behavioral: lifestyle modification project |
| control | Placebo comparator | This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization. Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative skeletal muscle index
RSMI(Unit: kg/m2)is defined as muscle mass
Measured: 3 months
Secondary outcomes (8)
Hand grip
HG(Unit: kg)is defined as muscle strength
Measured: 3 months
gait speed
GP(Unit: s)is defined as physical activity level
Measured: 3 months
quality of life on EQ-5D scale
Scores range from 0 [worse] to 1[best](Unit on a scale)
Measured: 3 months
The rate of fracture
rate of participants with fracture due to fall(Unit: %)
Measured: 3 months
the change of physical function on frail index
Scores range from 0 [normal] to 1[unhealth](Unit on a scale)
Measured: 3 months
the rate of infection complication
Rate of participants with infection complication due to sarcopenia(Unit: %)
Measured: 3 months
mortality rate
Rate of participants mortality(Unit: %)
Measured: 3 months
medical cost on cost-effectiveness ratio
the lower cost，the higher effectiveness(Unit: %)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kang Yu, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873676
- Sponsor's protocol ID
- PUMCH344801
- Status last verified
- Jun 2020
- First submitted
- 16 Sep 2015
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41126316Guo JY, Yu K, Li CW, Bao YY, Zhang Y, Wang F, Li RR, Xie HY. The application of Chinese version of SARC-F and SARC-CalF in sarcopenia screening against five definitions: a diagnostic test accuracy study. BMC Geriatr. 2024 Oct 26;24(1):883. doi: 10.1186/s12877-024-05460-w.
PubMed 39462351Li 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.
PubMed 33216623Li 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.
PubMed 30969486
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02873676
- Acronym / sponsor ID
- PUMCH344801
- Conditions
- Sarcopenia
- Keywords
- prevalence; lifestyle modification; clinical outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nutritional intervention | Experimental | Behavioral: nutritional interventionThis 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 | Experimental | Behavioral: resistance training programThis group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing. |
| lifestyle modification project | Experimental | Behavioral: lifestyle modification projectThis group receive multi-dimensional intensive nutritional intervention and resistance training program. |
| control | Placebo comparator | Behavioral: controlThis group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional interventionThe 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) | Behavioural | nutritional intervention |
| resistance training programThe training program involve warm-up exercise, muscle strength training and relaxing | Behavioural | resistance training program |
| lifestyle modification projectLifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training | Behavioural | lifestyle modification project |
| controlThe intervention involve dietary pattern modification and protein intake standardization | Behavioural | control |
Primary outcome
relative skeletal muscle index
Time frame: 3 months
RSMI(Unit: kg/m2)is defined as muscle mass
8 secondary outcomes
Hand grip
Time frame: 3 months
gait speed
Time frame: 3 months
quality of life on EQ-5D scale
Time frame: 3 months
The rate of fracture
Time frame: 3 months
the change of physical function on frail index
Time frame: 3 months
the rate of infection complication
Time frame: 3 months
mortality rate
Time frame: 3 months
medical cost on cost-effectiveness ratio
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 41126316Li 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.
- Derived from this study: PubMed 39462351Guo JY, Yu K, Li CW, Bao YY, Zhang Y, Wang F, Li RR, Xie HY. The application of Chinese version of SARC-F and SARC-CalF in sarcopenia screening against five definitions: a diagnostic test accuracy study. BMC Geriatr. 2024 Oct 26;24(1):883. doi: 10.1186/s12877-024-05460-w.
- Derived from this study: PubMed 33216623Li 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.
- Derived from this study: PubMed 30969486Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kang Yu study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention, resistance training program and lifestyle modification project in people with Sarcopenia, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Yu (+86 10 69155550, yuk1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative skeletal muscle index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02873676, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.