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Status unknownNCT02873676Updated Jun 16, 2020

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

An interventional study of nutritional intervention and resistance training program in Sarcopenia, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sarcopenia

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Keywords

  • prevalence; lifestyle modification; clinical outcomes
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In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    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).

    Behavioral: nutritional intervention

  • Experimental
    resistance training program

    This group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing.

    Behavioral: resistance training program

  • Experimental
    lifestyle modification project

    This group receive multi-dimensional intensive nutritional intervention and resistance training program.

    Behavioral: lifestyle modification project

  • Placebo comparator
    control

    This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization.

    Behavioral: control

Interventions

  • Behavioralnutritional 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)

  • Behavioralresistance training program

    The training program involve warm-up exercise, muscle strength training and relaxing

  • Behaviorallifestyle modification project

    Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training

  • Behavioralcontrol

    The intervention involve dietary pattern modification and protein intake standardization

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What researchers measure

Primary outcomes

  1. relative skeletal muscle index

    RSMI(Unit: kg/m2)is defined as muscle mass

    Time frame: 3 months

Secondary outcomes

  1. Hand grip

    HG(Unit: kg)is defined as muscle strength

    Time frame: 3 months

  2. gait speed

    GP(Unit: s)is defined as physical activity level

    Time frame: 3 months

  3. quality of life on EQ-5D scale

    Scores range from 0 \[worse\] to 1\[best\](Unit on a scale)

    Time frame: 3 months

  4. The rate of fracture

    rate of participants with fracture due to fall(Unit: %)

    Time frame: 3 months

  5. the change of physical function on frail index

    Scores range from 0 \[normal\] to 1\[unhealth\](Unit on a scale)

    Time frame: 3 months

  6. the rate of infection complication

    Rate of participants with infection complication due to sarcopenia(Unit: %)

    Time frame: 3 months

  7. mortality rate

    Rate of participants mortality(Unit: %)

    Time frame: 3 months

  8. medical cost on cost-effectiveness ratio

    the lower cost,the higher effectiveness(Unit: %)

    Time frame: 3 months

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Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, China
    Recruiting
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References and documents

Publications

  • Li 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 33216623 ↗
  • Li 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02873676
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
Mar 2016
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jun 16, 2020

Study contacts

Kang Yu
Contact
yuk1997@sina.com
+86 10 69155550
Kang Yu
study chair · Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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