SarcopeniaNCT05720416
Effects of a Multi-intervention Programme for the Elderly
A study testing protein supplementation and muscle strength training in people with Sarcopenia and Sarcopenic Obesity, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.
Trial summary
1. To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Sarcopenic Obesity, Dementia
- What is being tested?
- protein supplementation and muscle strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Aug 2023to 31 Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 60 years old, (2) able to Communicate and follow instructions; (3) Stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease.
Who cannot join
- difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Daycare center at Central Taiwan University of Science and Technology
Taichung
About this study
Official title: Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly
- To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.
- Conditions
- Sarcopenia, Sarcopenic Obesity, Dementia
- Being tested
- protein supplementation, muscle strength training, usual care
- Medical subject headings
- Sarcopenia, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementationDietary supplement
protein supplementation for 16 weeks
muscle strength trainingBehavioural
muscle strength training for 16 weeks
usual careOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| muscle strength training and protein supplementation | Experimental | Not described Receives: Dietary Supplement: protein supplementation; Behavioral: muscle strength training |
| usual care | Placebo comparator | Not described Receives: Other: usual care |
| muscle strength training | Experimental | Not described Receives: Behavioral: muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chang in muscle strength from baseline to 16 weeks
pinch, grip and quadriceps strength. A Higher score means a better outcome.
Measured: Baseline and 16 weeks
Chang in weight of muscle and fat from baseline to 16 weeks
muscle mass(kg), fat mass (kg)
Measured: Baseline and 16 weeks
Chang in Activities of Daily Living from baseline to 16 weeks
This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome.
Measured: Baseline and 16 weeks
Chang in Instrumental activities of daily living from baseline to 16 weeks
This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome.
Measured: Baseline and 16 weeks
Chang in Clinical Dementia Rating from baseline to 16 weeks
Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.
Measured: Baseline and 16 weeks
Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks
Mental Function Assessment. The range for total score is 0-38. A Higher score means a worse outcome.
Measured: Baseline and 16 weeks
Chang in Cohen-Mansfield Agitation Inventory from baseline to 16 weeks
This is a scale of behavior measurement. The range for total is 29-203. A higher score means a worse outcome.
Measured: Baseline and 16 weeks
Chang in EQ5D from baseline to 16 weeks
This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome.
Measured: Baseline and 16 weeks
Chang in QUALIDEM from baseline to 16 weeks
The scale is a dementia-specific Qol instrument. The range for total score is 0-120. A higher score means a better outcome.
Measured: Baseline and 16 weeks
Demographic attributes
Gender, education, age, married status, religion, medication, diseases, work and height.
Measured: Baseline
Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks
The range for total is 0-80. A higher score means a better outcome.
Measured: Baseline and 16 weeks
Chang in PERSONAL WELLBEING INDEX intellectual disability from baseline to 16 weeks
The range for total is 0-70. A higher score means a better outcome.
Measured: Baseline and 16 weeks.
Chang in World Health Organization Quality of Life Instruments (WHOQOL-BREF) from baseline to 16 weeks
This is a scale of quality of life. The range for total is 26-130. A higher score means a better outcome.
Measured: Baseline and 16 weeks.
Chang in Four-Meter Gait Speed from baseline to 16 weeks
Measured with seconds. A higher score means a worse outcome.
Measured: Baseline and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start22 Aug 2023
- Primary completion30 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Taiwan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiu Shu-Ching, Central Taiwan University of Science and Technology
- Investigators
- Chiu, Principal investigator, Central Taiwan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720416
- Sponsor's protocol ID
- 202300020A3
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly
- ClinicalTrials.gov ID
- NCT05720416
- Acronym / sponsor ID
- 202300020A3
- Conditions
- Sarcopenia, Sarcopenic Obesity, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Central Taiwan University of Science and TechnologyUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Feb 2023 (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.
- To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| muscle strength training and protein supplementation | Experimental | Dietary Supplement: protein supplementation, Behavioral: muscle strength training |
| usual care | Placebo comparator | Other: usual care |
| muscle strength training | Experimental | Behavioral: muscle strength training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over 60 years old, (2) able to Communicate and follow instructions; (3) Stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease.
Key exclusion criteria (1 listed)
- difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.
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 |
|---|---|---|
| protein supplementationprotein supplementation for 16 weeks | Dietary supplement | muscle strength training and protein supplementation |
| muscle strength trainingmuscle strength training for 16 weeks | Behavioural | muscle strength training, muscle strength training and protein supplementation |
| usual careno intervention | Other | usual care |
Primary outcome
Chang in muscle strength from baseline to 16 weeks
Time frame: Baseline and 16 weeks
pinch, grip and quadriceps strength. A Higher score means a better outcome.
Chang in weight of muscle and fat from baseline to 16 weeks
Time frame: Baseline and 16 weeks
muscle mass(kg), fat mass (kg)
Chang in Activities of Daily Living from baseline to 16 weeks
Time frame: Baseline and 16 weeks
This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome.
Chang in Instrumental activities of daily living from baseline to 16 weeks
Time frame: Baseline and 16 weeks
This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome.
Chang in Clinical Dementia Rating from baseline to 16 weeks
Time frame: Baseline and 16 weeks
Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.
Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks
Time frame: Baseline and 16 weeks
Mental Function Assessment. The range for total score is 0-38. A Higher score means a worse outcome.
Chang in Cohen-Mansfield Agitation Inventory from baseline to 16 weeks
Time frame: Baseline and 16 weeks
This is a scale of behavior measurement. The range for total is 29-203. A higher score means a worse outcome.
Chang in EQ5D from baseline to 16 weeks
Time frame: Baseline and 16 weeks
This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome.
Chang in QUALIDEM from baseline to 16 weeks
Time frame: Baseline and 16 weeks
The scale is a dementia-specific Qol instrument. The range for total score is 0-120. A higher score means a better outcome.
Demographic attributes
Time frame: Baseline
Gender, education, age, married status, religion, medication, diseases, work and height.
Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks
Time frame: Baseline and 16 weeks
The range for total is 0-80. A higher score means a better outcome.
Chang in PERSONAL WELLBEING INDEX intellectual disability from baseline to 16 weeks
Time frame: Baseline and 16 weeks.
The range for total is 0-70. A higher score means a better outcome.
Chang in World Health Organization Quality of Life Instruments (WHOQOL-BREF) from baseline to 16 weeks
Time frame: Baseline and 16 weeks.
This is a scale of quality of life. The range for total is 26-130. A higher score means a better outcome.
Chang in Four-Meter Gait Speed from baseline to 16 weeks
Time frame: Baseline and 16 weeks.
Measured with seconds. A higher score means a worse outcome.
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 Mar 2025.
- 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.
Chiu principal investigator
Central Taiwan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplementation and muscle strength training in people with Sarcopenia and Sarcopenic Obesity, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.
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 1 inclusion and 1 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 Mar 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Chang in muscle strength from baseline to 16 weeks (time frame: Baseline and 16 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.