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

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ClinicalTrials.gov Identifier: NCT02873676
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
gwcmc

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Behavioral: nutritional intervention Behavioral: resistance training program Behavioral: lifestyle modification project Behavioral: control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
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 Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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




Primary Outcome Measures :
  1. relative skeletal muscle index [ Time Frame: 3 months ]
    RSMI(Unit: kg/m2)is defined as muscle mass


Secondary Outcome Measures :
  1. Hand grip [ Time Frame: 3 months ]
    HG(Unit: kg)is defined as muscle strength

  2. gait speed [ Time Frame: 3 months ]
    GP(Unit: s)is defined as physical activity level

  3. quality of life on EQ-5D scale [ Time Frame: 3 months ]
    Scores range from 0 [worse] to 1[best](Unit on a scale)

  4. The rate of fracture [ Time Frame: 3 months ]
    rate of participants with fracture due to fall(Unit: %)

  5. the change of physical function on frail index [ Time Frame: 3 months ]
    Scores range from 0 [normal] to 1[unhealth](Unit on a scale)

  6. the rate of infection complication [ Time Frame: 3 months ]
    Rate of participants with infection complication due to sarcopenia(Unit: %)

  7. mortality rate [ Time Frame: 3 months ]
    Rate of participants mortality(Unit: %)

  8. medical cost on cost-effectiveness ratio [ Time Frame: 3 months ]
    the lower cost,the higher effectiveness(Unit: %)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873676


Contacts
Contact: Kang Yu +86 10 69155550 yuk1997@sina.com

Locations
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Kang Yu    +86 13801130457    yuk1997@sina.com   
Sponsors and Collaborators
gwcmc
Investigators
Study Chair: Kang Yu Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Responsible Party: gwcmc
ClinicalTrials.gov Identifier: NCT02873676     History of Changes
Other Study ID Numbers: PUMCH344801
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: March 2016

Keywords provided by gwcmc:
prevalence; lifestyle modification; clinical outcomes

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms