Intervention Assessing the Role of Exercise Program and Nutrition Supplement for Sarcopenia

January 11, 2018 updated by: Ruth Chan, Chinese University of Hong Kong

Intervention for Sarcopenia Among Older Chinese Adults: A Randomized Controlled Trial Assessing the Role of Exercise Program and Nutrition Supplement

Sarcopenia represents the loss of skeletal muscle and strength that occurs with aging. It is a major component of frailty and its effect on daily functioning, falls, and fractures has been well documented. Along with the population aging worldwide, the number of people with sarcopenia is expected to increase and, thus, contributing to dependency and the anticipated increase in health and social care costs. The cause of sarcopenia is multifactorial. Recent evidence suggests that some reversibility exists, highlighting the importance of intervention modalities. However, the role of nutritional supplementation and exercise programs, either individually or in combination, is still uncertain, and further randomized controlled trials (RCTs) have been recommended by the International Sarcopenia Initiative. Therefore, the investigators plan to conduct a 24-month RCT to compare the effectiveness of 12-week exercise program alone, combined exercise program and nutrition supplement, and non-exercise control group on improving muscle mass, strength and power and physical performance in Chinese older people who have sarcopenia defined using the Asian Working Group Criteria (AWGC). The investigators hypothesize that compared with the non-exercise control group, there will be improvement in muscle strength, power and mass, and physical performance in the exercise alone group, and that there will be an additive effect with the combined exercise and nutrition supplement group. Chinese older people aged 65 years and over will be recruited for a brief screening of sarcopenia and cognitive status. Potential subjects will further undertake detailed body composition and biochemical measurements to check for their eligibility. Eligible subjects will be randomized to one of the three groups: exercise program alone, combined exercise program and nutrition supplement, or waitlist control group with the same exercise program offered after 24-week of study enrollment. Each group will have 45 subjects. Outcome measurements including muscle strength, power and mass, physical performance, instrumental activities of daily living and related biochemical measurements will be made at baseline, 12 and 24 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Hong Kong, China
        • Chinese University of Hong Kong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese origin
  • Normally reside in Hong Kong
  • Could speak and understand Chinese
  • With handgrip strength less than 26 kg for men and 18 kg for women and/or usual gait speed less than or equal to 0.8 m/s, as recommended by the Asian Working Group on Sarcopenia (AWGS)
  • With height-adjusted appendicular skeletal muscle mass (ASM/ht2) measured using dual X-ray absorptiometry (DEXA) less than 7.0 kg/m2 for men and 5.4 kg/m2 for women, as recommended by the AWGS
  • Willing to follow the study procedures

Exclusion Criteria:

  • Recent (i.e. past 3 months) or concurrent participation in any clinical trial or dietary and/or exercise intervention program
  • Self-reported allergy to the ingredients of the nutrition supplement
  • Use of medications that could affect study outcomes
  • With cancer conditions that are currently undergoing treatment
  • Poorly controlled or unstable chronic obstructive pulmonary disease
  • Poorly controlled or unstable cardiovascular disease or diabetes or hypertension
  • Recent unhealed bone fracture (within the past 12 months)
  • With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program
  • With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise program alone
There will be 2 site sessions and 1 home session per week for 12 weeks. Each site exercise session will begin and end with a 5-10 minute warm-up and cool-down routine. The first part of the exercise program consists of 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body. To target the development of muscle power in both the lower and upper extremities, participants will be instructed to perform each concentric movement 'as rapidly as possible,' and the eccentric movement in a slow and controlled manner. A 5-minute rest period will be given prior to the start of the second part of the exercise program that consists of aerobic exercises such as ball games using fitballs or Taichi. Participants will be asked to spend an hour/week on home exercise. Thera-Bands and a leaflet showing the exercise procedures will be given to them and their caregivers.
Behavioral: Exercise program alone
Experimental: Exercise program plus nutrition supplement
This group will receive both the exercise program as well as the nutrition supplement. The components of the exercise program will be same as those of the exercise program alone group. Participants will also be asked to consume two sachets of Ensure NutriVigor every day during the 12-week intervention period. Ensure NutriVigor (one sachet of 54.1 g powder) contains 231 calories, 8.61 g protein, 1.21 g hydroxyl-methyl-butyrate (HMB), 130 IU vitamin D, and 0.29 g omega 3 fatty acid per serving. Participants will be instructed on how to prepare the supplement.
Behavioral: Exercise program alone
Dietary supplement: Combined exercise program and nutrition supplement
Other: Waitlist control group
This group will be asked to maintain their usual physical activities and dietary habits during the first 6 months of study period. After they complete the 24-week measurement, they will receive the same 12-week exercise program as of the exercise program alone group.
Other: Waitlist control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in gait speed
Time Frame: baseline, 12 weeks
This outcome will be measured using the 6-meter walk test
baseline, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: baseline, 12 weeks
Handgrip strength will be measured using a dynamometer
baseline, 12 weeks
Bilateral leg extensors strength
Time Frame: baseline, 12 weeks
Bilateral leg extensors strength will be measured by spring gauge while seated, and the average value between right and left will be used for analysis.
baseline, 12 weeks
Muscle power in the upper extremities
Time Frame: baseline, 12 weeks
This outcome will be measured using seated 1.8kg medicine ball throw test (maximum throw distance achieved in 3 trials).
baseline, 12 weeks
Muscle power in the lower extremities
Time Frame: baseline, 12 weeks
This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).
baseline, 12 weeks
Height-adjusted appendicular skeletal muscle mass
Time Frame: baseline, 12 weeks
This outcome will be measured using dual X-ray absorptiometry (DEXA)
baseline, 12 weeks
Improvement in sarcopenia category
Time Frame: baseline, 12 weeks
This outcome will be measured using DEXA
baseline, 12 weeks
Health-related quality of life
Time Frame: baseline, 12 weeks
This outcome will be measured using validated Chinese version of short form (SF)-12
baseline, 12 weeks
Instrumental Activities of Daily Living (IADL)
Time Frame: baseline, 12 weeks
Participants will be asked to self-report of any impairment in walking two to three blocks outdoors on level ground, climbing 10 steps without resting, preparing own meals, doing heavy housework like scrubbing floors or washing windows, and shopping for groceries or clothes. A summed score from 0 to 5 was calculated from these activities as the degree of impairment in IADLs, with higher score indicating greater impairment.
baseline, 12 weeks
Cardiorespiratory fitness
Time Frame: baseline, 12 weeks
Cardiorespiratory fitness will be measured by 6-minute walk test (6MWT). 6MWT will be completed and scored as the total number of meters walked in 6 minutes.
baseline, 12 weeks
Serum cystatin C measurement measured using immunoassay method
Time Frame: baseline, 12 weeks
For combined exercise program and nutrition supplement group only
baseline, 12 weeks
Renal function test measured by University Pathology Service
Time Frame: baseline, 12 weeks
For combined exercise program and nutrition supplement group only
baseline, 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting blood samples for genetic study of genes related to physical function, sarcopenia and frailty
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change in gait speed
Time Frame: 12 weeks, 24 weeks
This outcome will be measured using the 6-meter walk test
12 weeks, 24 weeks
Handgrip strength
Time Frame: 12 weeks, 24 weeks
Handgrip strength will be measured using a dynamometer
12 weeks, 24 weeks
Bilateral leg extensors strength
Time Frame: 12 weeks, 24 weeks
Bilateral leg extensors strength will be measured by spring gauge while seated, and the average value between right and left will be used for analysis.
12 weeks, 24 weeks
Muscle power in the upper extremities
Time Frame: 12 weeks, 24 weeks
This outcome will be measured using seated 1.5kg medicine ball throw test (maximum throw distance achieved in 3 trials).
12 weeks, 24 weeks
Muscle power in the lower extremities
Time Frame: 12 weeks, 24 weeks
This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).
12 weeks, 24 weeks
Height-adjusted appendicular skeletal muscle mass
Time Frame: 12 weeks, 24 weeks
This outcome will be measured using DEXA
12 weeks, 24 weeks
Improvement in sarcopenia category
Time Frame: 12 weeks, 24 weeks
This outcome will be measured using DEXA
12 weeks, 24 weeks
Health-related quality of life
Time Frame: 12 weeks, 24 weeks
This outcome will be measured using validated Chinese version of SF-12
12 weeks, 24 weeks
Instrumental Activities of Daily Living
Time Frame: 12 weeks, 24 weeks
Participants will be asked to self-report of any impairment in walking two to three blocks outdoors on level ground, climbing 10 steps without resting, preparing own meals, doing heavy housework like scrubbing floors or washing windows, and shopping for groceries or clothes. A summed score from 0 to 5 was calculated from these activities as the degree of impairment in IADLs, with higher score indicating greater impairment.
12 weeks, 24 weeks
Cardiorespiratory fitness
Time Frame: 12 weeks, 24 weeks
Cardiorespiratory fitness will be measured by 6-minute walk test (6MWT). 6MWT will be completed and scored as the total number of meters walked in 6 minutes.
12 weeks, 24 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014.648-T

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