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

June 13, 2020 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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)
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
The training program involve warm-up exercise, muscle strength training and relaxing
Experimental: lifestyle modification project
This group receive multi-dimensional intensive nutritional intervention and resistance training program.
Behavioral: lifestyle modification project
Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training
Placebo Comparator: control
This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization.
Behavioral: control
The intervention involve dietary pattern modification and protein intake standardization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relative skeletal muscle index
Time Frame: 3 months
RSMI(Unit: kg/m2)is defined as muscle mass
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Kang Yu, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH344801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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