SarcopeniaNCT03650907
Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
A study testing Group exercise program and Self exercise program in people with Sarcopenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Sarcopenia is a geriatric syndrome of decreased muscle volume with muscular function decline. There is more tendency for sarcopenic elderly to be frail, disabled, or have cardiovascular disease. Read more about this study
- Who is it for?
- Ages 20 to 110 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Group exercise program and Self exercise program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2018to 31 May 2019
- 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 20 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >20-year-old
- diagnosed with sarcopenia (by the definition from Asia workgroup for sarcopenia, AWGS) or frailty (The Fried model, based on five functional criteria)
Who cannot join
- Severe medical diseases or mental problems, which result in difficulty to follow exercise program.
- Inability to get down from bed for activity due to disease, such as neuropathy or orthopedic disease.
- High risk group for exercise program, such as those with unstable fracture or nonunion fracture.
- Anyone who didn't want attend this study.
Trial locations and contacts
1 site in 1 country.
About this study
Sarcopenia is a geriatric syndrome of decreased muscle volume with muscular function decline. There is more tendency for sarcopenic elderly to be frail, disabled, or have cardiovascular disease. Compared to those who are not sarcopenic, they also had worse prognosis in response to treatment for definite diseases, and spend more medical cost.
Exercise appears to have an important role in management of sarcopenia. In the current study, the investigators provide an exercise program, including resistance/balance training for the elderly with sarcopenia or frailty in long-term care institution, and evaluate the effect.
- Conditions
- Sarcopenia
- Being tested
- Group exercise program, Self exercise program
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exercise programBehavioural
Patients in experimental group attend group exercise program, instructed by fitness trainer, at long-term care institutions.
Frequency: 3 times per week. Type: resistance/flexibility/balance training, including warm-up and cold-down. Duration: 1 hour per time, for 16 weeks.
Self exercise programBehavioural
Patients in control group receive oral education for self exercise program, mainly resistance muscle training. Patients are requested to do self-training for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group exercise program by coach | Experimental | Not described Receives: Behavioral: Group exercise program |
| Self exercise | Sham comparator | Not described Receives: Behavioral: Self exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
grasp strength by dynamometer
Measured: after 16-weeks training
walk speed
6-meter walk test
Measured: after 16-weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start24 Aug 2018
- Primary completion31 May 2019
- Study completion31 May 2019
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.
- More trials run by Chang Gung Memorial HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Chun Tseng, Chang Gung Memorial Hospital
- Investigators
- Wen-Chun Tseng, Principal investigator, Chang Gung Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650907
- Sponsor's protocol ID
- SarcExercise
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention for Patients With Sarcopenia or Frailty in Long-term Care Institutions
- ClinicalTrials.gov ID
- NCT03650907
- Acronym / sponsor ID
- SarcExercise
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 29 Aug 2018 (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.
Sarcopenia is a geriatric syndrome of decreased muscle volume with muscular function decline. There is more tendency for sarcopenic elderly to be frail, disabled, or have cardiovascular disease. Compared to those who are not sarcopenic, they also had worse prognosis in response to treatment for definite diseases, and spend more medical cost.
Exercise appears to have an important role in management of sarcopenia. In the current study, the investigators provide an exercise program, including resistance/balance training for the elderly with sarcopenia or frailty in long-term care institution, and evaluate the effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group exercise program by coach | Experimental | Behavioral: Group exercise program |
| Self exercise | Sham comparator | Behavioral: Self exercise program |
Who may qualify
- Ages
- 20 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >20-year-old
- diagnosed with sarcopenia (by the definition from Asia workgroup for sarcopenia, AWGS) or frailty (The Fried model, based on five functional criteria)
Key exclusion criteria (4 listed)
- Severe medical diseases or mental problems, which result in difficulty to follow exercise program.
- Inability to get down from bed for activity due to disease, such as neuropathy or orthopedic disease.
- High risk group for exercise program, such as those with unstable fracture or nonunion fracture.
- Anyone who didn't want attend this study.
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 |
|---|---|---|
| Group exercise programPatients in experimental group attend group exercise program, instructed by fitness trainer, at long-term care institutions. Frequency: 3 times per week. Type: resistance/flexibility/balance training, including warm-up and cold-down. Duration: 1 hour per time, for 16 weeks. | Behavioural | Group exercise program by coach |
| Self exercise programPatients in control group receive oral education for self exercise program, mainly resistance muscle training. Patients are requested to do self-training for 16 weeks. | Behavioural | Self exercise |
Primary outcome
Muscle strength
Time frame: after 16-weeks training
grasp strength by dynamometer
walk speed
Time frame: after 16-weeks training
6-meter walk test
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 13 Aug 2019.
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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.
Wen-Chun Tseng principal investigator
Chang Gung Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group exercise program and Self exercise program in people with Sarcopenia, run by Chang Gung Memorial Hospital 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 2 inclusion and 4 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 13 Aug 2019. 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?
Muscle strength (time frame: after 16-weeks training). The study lists 2 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 13 Aug 2019.