SarcopeniaNCT02374268
Intervention Assessing the Role of Exercise Program and Nutrition Supplement for Sarcopenia
A study testing Exercise program alone and Combined exercise program and nutrition supplement in people with Sarcopenia, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Exercise program alone and Combined exercise program and nutrition supplement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sarcopenia
- Being tested
- Exercise program alone, Combined exercise program and nutrition supplement, Waitlist control group
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program aloneBehavioural
Combined exercise program and nutrition supplementDietary supplement
Waitlist control groupOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise program alone | Experimental | 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. Receives: Behavioral: Exercise program alone |
| Exercise program plus nutrition supplement | Experimental | 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. Receives: Behavioral: Exercise program alone; Dietary Supplement: Combined exercise program and nutrition supplement |
| Waitlist control group | Other | 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. Receives: Other: Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
This outcome will be measured using the 6-meter walk test
Measured: baseline, 12 weeks
Secondary outcomes (11)
Handgrip strength
Handgrip strength will be measured using a dynamometer
Measured: baseline, 12 weeks
Bilateral leg extensors strength
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.
Measured: baseline, 12 weeks
Muscle power in the upper extremities
This outcome will be measured using seated 1.8kg medicine ball throw test (maximum throw distance achieved in 3 trials).
Measured: baseline, 12 weeks
Muscle power in the lower extremities
This outcome will be measured using 5-chair stand test (time to complete standing from a chair 5 times as quickly as possible).
Measured: baseline, 12 weeks
Height-adjusted appendicular skeletal muscle mass
This outcome will be measured using dual X-ray absorptiometry (DEXA)
Measured: baseline, 12 weeks
Improvement in sarcopenia category
This outcome will be measured using DEXA
Measured: baseline, 12 weeks
Health-related quality of life
This outcome will be measured using validated Chinese version of short form (SF)-12
Measured: baseline, 12 weeks
Instrumental Activities of Daily Living (IADL)
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.
Measured: baseline, 12 weeks
Cardiorespiratory fitness
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.
Measured: baseline, 12 weeks
Serum cystatin C measurement measured using immunoassay method
For combined exercise program and nutrition supplement group only
Measured: baseline, 12 weeks
Renal function test measured by University Pathology Service
For combined exercise program and nutrition supplement group only
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374268
- Sponsor's protocol ID
- 2014.648-T
- Status last verified
- Jan 2018
- First submitted
- 12 Feb 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.
PubMed 30462162
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Sarcopenia Among Older Chinese Adults: A Randomized Controlled Trial Assessing the Role of Exercise Program and Nutrition Supplement
- ClinicalTrials.gov ID
- NCT02374268
- Acronym / sponsor ID
- 2014.648-T
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise program alone | Experimental | Behavioral: Exercise program aloneThere 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. |
| Exercise program plus nutrition supplement | Experimental | Behavioral: Exercise program alone, Dietary Supplement: Combined exercise program and nutrition supplementThis 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. |
| Waitlist control group | Other | Other: Waitlist control groupThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program alone | Behavioural | Exercise program alone, Exercise program plus nutrition supplement |
| Combined exercise program and nutrition supplement | Dietary supplement | Exercise program plus nutrition supplement |
| Waitlist control group | Other | Waitlist control group |
Primary outcome
Change in gait speed
Time frame: baseline, 12 weeks
This outcome will be measured using the 6-meter walk test
11 secondary outcomes
Handgrip strength
Time frame: baseline, 12 weeks
Bilateral leg extensors strength
Time frame: baseline, 12 weeks
Muscle power in the upper extremities
Time frame: baseline, 12 weeks
Muscle power in the lower extremities
Time frame: baseline, 12 weeks
Height-adjusted appendicular skeletal muscle mass
Time frame: baseline, 12 weeks
Improvement in sarcopenia category
Time frame: baseline, 12 weeks
Health-related quality of life
Time frame: baseline, 12 weeks
Instrumental Activities of Daily Living (IADL)
Time frame: baseline, 12 weeks
Cardiorespiratory fitness
Time frame: baseline, 12 weeks
Serum cystatin C measurement measured using immunoassay method
Time frame: baseline, 12 weeks
Renal function test measured by University Pathology Service
Time frame: baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 30462162Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program alone and Combined exercise program and nutrition supplement in people with Sarcopenia, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.