SarcopeniaNCT06287502
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
A study testing β-hydroxy β-methylbutyrate (HMB) and Resistance, aerobic, flexibility and balance exercise training in people with Sarcopenia and Osteoporosis, run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, Osteoporosis
- What is being tested?
- β-hydroxy β-methylbutyrate (HMB) and Resistance, aerobic, flexibility and balance exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Sep 2022to 30 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of sarcopenia:
- Low hand grip strength (Male: <28 kg, Female: <18 kg) AND
- Low appendicular skeletal mass by bioimpedance analysis (Male: <7.0 kg/m2 Female: <5.7 kg/m2)
- Diagnosed with osteoporosis by:
- Fragility fracture or
- T-score ≤-2.5 SDs at any site based upon BMD measurement by Dual Energy X-ray Absorptiometry (DXA) scan
Who cannot join
- Incompetent in giving consent or following commands
- Non-ambulatory subject
- Unstable medical conditions contributing to sarcopenia, for example but not limited to:
- End stage organ failure
- Unstable cardiovascular, respiratory, gastrointestinal and endocrine conditions
- Active malignancy
Show all 15Show fewer
- Chronic kidney disease stage IV or above or with hyperkalaemia
- Diabetes mellitus on medications or with unstable control
- Terminal illness
- Obese subjects (BMI ≥ 25.0)
- Self-reported allergy to the ingredients of the nutrition supplement
- Patients with metallic implants
- Any orthopaedic pathologies affecting the strength of bilateral upper limbs
- Any hereditary or acquired muscular diseases
- Participation in other regular exercise programme
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.
- Conditions
- Sarcopenia, Osteoporosis
- Being tested
- β-hydroxy β-methylbutyrate (HMB), Resistance, aerobic, flexibility and balance exercise training
- Medical subject headings
- Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-hydroxy β-methylbutyrate (HMB)Dietary supplement
Ensure NutriVigor, a nutritional supplement, was provided to subjects according to the manufacturer's recommendation of two servings per day. Each serving consists of 54.1g of powder which provides ~231kcal, 8.61g protein, 1.21 g β-hydroxy β-methylbutyrate, 130 IU vitamin D and 0.29 g omega-3 fatty acid.
Resistance, aerobic, flexibility and balance exercise trainingBehavioural
The exercise intervention consists of 75-minutes sessions delivered by physiotherapists at the Integrated Rehabilitation Day Centre (IRDC) in Kowloon Hospital, twice per week for 12 weeks with a total of 24 supervised sessions. Each exercise session consists of 5 minutes of warm up, 30 minutes of resistance training, 20 minutes of aerobic training, 15 minutes of balance or neuromuscular exercises and 5 minutes of cool down.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB) during the 12-week study period. Receives: Dietary Supplement: β-hydroxy β-methylbutyrate (HMB); Behavioral: Resistance, aerobic, flexibility and balance exercise training |
| Wait-list control | No intervention | The waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Grip strength was measured with Jamar Plus+ digital hand dynamometer (Performance Health Supply, Wisconsin, United States).
Measured: 12 weeks
Secondary outcomes (6)
Body weight
Measured: 12 weeks
Body mass index
Measured: 12 weeks
Appendicular skeletal muscle mass index
ASMI was measured with a bioimpedance analyser, InBody 270 (InBody, Seoul, South Korea).
Measured: 12 weeks
6-metre walk test
In 6-metre walk test, a 10-metre walkway is marked at the 0-, 2-, 8-, and 10-metre points. The time for the patient to finish the central 6 metres will be recorded by a digital stopwatch by the same tester.
Measured: 12 weeks
5-time chair stand test
Starting from sitting on a standard chair with folded arm across chest, subject is asked to rise from the chair and return to the seated position as quickly as possible for five repetitions.
Measured: 12 weeks
Short Physical Performance Battery (SPPB)
The SPPB, a reliable and valid tool to evaluate functional capability, consisted of three components: standing balance, walking speed and chair stand .
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start9 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Hin Cheung, Kowloon Hospital, Hong Kong
- Investigators
- Hin Cheung Leung, MBChB, Principal investigator, Kowloon Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287502
- Sponsor's protocol ID
- KHRehab_LeungHC_2
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
PubMed 32033882Zhu 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
- ClinicalTrials.gov ID
- NCT06287502
- Acronym / sponsor ID
- KHRehab_LeungHC_2
- Conditions
- Sarcopenia, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Mar 2024 (actual)
- 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.
This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: β-hydroxy β-methylbutyrate (HMB), Behavioral: Resistance, aerobic, flexibility and balance exercise trainingSubjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB) during the 12-week study period. |
| Wait-list control | No intervention | –The waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of sarcopenia:
- Diagnosed with osteoporosis by:
Key exclusion criteria (15 listed)
- Incompetent in giving consent or following commands
- Non-ambulatory subject
- Unstable medical conditions contributing to sarcopenia, for example but not limited to:
- Chronic kidney disease stage IV or above or with hyperkalaemia
- Diabetes mellitus on medications or with unstable control
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 |
|---|---|---|
| β-hydroxy β-methylbutyrate (HMB)Ensure NutriVigor, a nutritional supplement, was provided to subjects according to the manufacturer's recommendation of two servings per day. Each serving consists of 54.1g of powder which provides ~231kcal, 8.61g protein, 1.21 g β-hydroxy β-methylbutyrate, 130 IU vitamin D and 0.29 g omega-3 fatty acid. | Dietary supplement | Intervention |
| Resistance, aerobic, flexibility and balance exercise trainingThe exercise intervention consists of 75-minutes sessions delivered by physiotherapists at the Integrated Rehabilitation Day Centre (IRDC) in Kowloon Hospital, twice per week for 12 weeks with a total of 24 supervised sessions. Each exercise session consists of 5 minutes of warm up, 30 minutes of resistance training, 20 minutes of aerobic training, 15 minutes of balance or neuromuscular exercises and 5 minutes of cool down. | Behavioural | Intervention |
Primary outcome
Grip strength
Time frame: 12 weeks
Grip strength was measured with Jamar Plus+ digital hand dynamometer (Performance Health Supply, Wisconsin, United States).
6 secondary outcomes
Body weight
Time frame: 12 weeks
Body mass index
Time frame: 12 weeks
Appendicular skeletal muscle mass index
Time frame: 12 weeks
6-metre walk test
Time frame: 12 weeks
5-time chair stand test
Time frame: 12 weeks
Short Physical Performance Battery (SPPB)
Time frame: 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 23 Sep 2025.
- Background: PubMed 32033882Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Hin Cheung Leung, MBChB principal investigator
Kowloon Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-hydroxy β-methylbutyrate (HMB) and Resistance, aerobic, flexibility and balance exercise training in people with Sarcopenia and Osteoporosis, run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
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 15 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 23 Sep 2025. 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 Hong Kong. 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?
Grip strength (time frame: 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 NCT06287502, which also lists 2 linked publications.
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 23 Sep 2025.