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

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nutritional intervention
resistance training program
lifestyle modification project
control
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sarcopenia focused on measuring prevalence; lifestyle modification; clinical outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

nutritional intervention

resistance training program

lifestyle modification project

control

Arm Description

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).

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2015
Last Updated
June 13, 2020
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02873676
Brief Title
Prevalence and Effect of Lifestyle Modification on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
prevalence; lifestyle modification; clinical outcomes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nutritional intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
resistance training program
Arm Type
Experimental
Arm Description
This group received resistance training program which is made up warm-up exercise, muscle strength training and relaxing.
Arm Title
lifestyle modification project
Arm Type
Experimental
Arm Description
This group receive multi-dimensional intensive nutritional intervention and resistance training program.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
This group receive nutritional consulting,which involve dietary pattern modification and protein intake standardization.
Intervention Type
Behavioral
Intervention Name(s)
nutritional intervention
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
resistance training program
Intervention Description
The training program involve warm-up exercise, muscle strength training and relaxing
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification project
Intervention Description
Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
The intervention involve dietary pattern modification and protein intake standardization
Primary Outcome Measure Information:
Title
relative skeletal muscle index
Description
RSMI(Unit: kg/m2)is defined as muscle mass
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hand grip
Description
HG(Unit: kg)is defined as muscle strength
Time Frame
3 months
Title
gait speed
Description
GP(Unit: s)is defined as physical activity level
Time Frame
3 months
Title
quality of life on EQ-5D scale
Description
Scores range from 0 [worse] to 1[best](Unit on a scale)
Time Frame
3 months
Title
The rate of fracture
Description
rate of participants with fracture due to fall(Unit: %)
Time Frame
3 months
Title
the change of physical function on frail index
Description
Scores range from 0 [normal] to 1[unhealth](Unit on a scale)
Time Frame
3 months
Title
the rate of infection complication
Description
Rate of participants with infection complication due to sarcopenia(Unit: %)
Time Frame
3 months
Title
mortality rate
Description
Rate of participants mortality(Unit: %)
Time Frame
3 months
Title
medical cost on cost-effectiveness ratio
Description
the lower cost，the higher effectiveness(Unit: %)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang Yu
Phone
+86 10 69155550
Email
yuk1997@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Yu
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Yu
Phone
+86 13801130457
Email
yuk1997@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33216623
Citation
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.
Results Reference
derived
PubMed Identifier
30969486
Citation
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.
Results Reference
derived

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

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