FrailtyNCT00718432
An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
A study testing Exercise and nutritional integrated care and Problem solving therapy (PST) integrated care in people with Frailty and Osteoporosis, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having these conditions are associated with adverse outcome in physical health, mental health, quality of life, and daily functioning. They are associated with higher mortality rates as well as increased health care cost. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Frailty, Osteoporosis, Depression
- What is being tested?
- Exercise and nutritional integrated care and Problem solving therapy (PST) integrated care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Dec 2010
- 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 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Scored 3-6 with the "Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese Telephone Interview Version" (Telephone Interview Version is replaced by In-Person Interview Version in 2009 study)
- Frailty index ≥ 1
Who cannot join
- Nursing home residents
- Cannot speak any of the following three dialogues: Mandarin, Taiwanese and Haga
- Hearing impairment interfering with communication or daily activities
- Visual impairment interfering with communication or daily activities.
- Cannot complete the screening instrument with the CSHA-CFS Chinese Telephone/In-Person Interview Version
- Scored 1, 2, or 7 with the CSHA-CFS Chinese Telephone/In-Person Interview Version
Show all 11Show fewer
- Cognitive impairment defined as 3-item recall ≤ 1
- Functional Impairment defined as not able to walk for 5 meters without assistance
- Suicidal Ideation defined as Suicide Subscale of The Mini-International Neuropsychiatric Interview (M.I.N.I.) ≥ 6
- Alcohol abuse disorders active within the last year. (score ≥ 2 on the CAGE)
- Organic mental disorders (Seizure, brain tumor, brain surgeries), History of schizophrenia or bipolar diagnosed from psychiatrist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.
Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having these conditions are associated with adverse outcome in physical health, mental health, quality of life, and daily functioning. They are associated with higher mortality rates as well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and interventions of these three geriatric syndromes are often related. Frailty is often defined as accumulations of multi-system deficiencies with increased vulnerability to multiple worse outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older adults may have positive impacts on measurements associated with not only frailty, but also depression, or osteoporosis. The objective of this proposed study is to conduct a randomized control trial (RCT) to exam the effectiveness of integrated interventions on multiple outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or osteoporosis, depression. We also plan to determine the differential effects of intervention between urban and rural area.
Read the detailed description
This is a three-year study. In the first year, we conducted a pilot study to test the feasibility of implementing integrated model on frailty, osteoporosis, depression, and other outcomes. Another objective is to determine optimal sample size for next level intervention in year 2 and 3 (2009 study).
Subjects are community-dwelling Taiwanese elders (65-79 years of age) living in Toufen Town in Miaoli County, Taiwan. Subjects are first screened with telephone interviews with the Chinese Canadian Study of Health and Aging _Clinical Frailty Scale (CCSHA_CFS). Eligible subjects are invited to a community hospital to be screened with the Health Study Phenotypic Classification of Frailty (CHS_PCF). Subjects scored ≥ 1 on the CHS_PCF are enrolled. With a 2 by 2 factorial design, subjects are first randomized into exercise/nutrition integrated care (ENIC) group and usual care (UC) group with education. Within each group, subjects are further randomized into problem solving therapy (PST) and usual care (UC) group with education by study care managers with pre-specified protocol. UC group subject received a study educational booklet with telephone follow up on compliance of booklet reading and suggested diet and exercise programs. Besides the booklets, ENIC group subjects received structured exercise 3 times/week with nutrition consultation as needed at hospital for 3 months while PST group subjects received 6 sessions of PST at hospital in 3 months.
Subjects were followed at 3, 6 and 12 months. Primary outcome is improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline analysis. Secondary outcomes include the physical function and performance, cognition, depression, quality of life, healthcare resource utilizations and bone-mineral density (BMD). Intention-to-treat analysis was applied.
The pilot study enrolled 117 subjects, after analysis of the preliminary results, the study protocol for the second and third year (2009 study) is modified as follows:
- The study is conducted at one urban (Wanhua) and one rural (Toufen) site with roughly 150 participants at each site.
- Convenient samples referred from participant physicians' clinics instead of the population based samples in year 1 are used to decrease administration cost.
- Telephone based first stage screening instrument will be modified and validated for face to face interview.
- Longer intervention period (6-months) than year 1.
- Interventions provided in ENIC and PSTIC groups are combined into a single integrated care (IC) group. Interventions for IC group and UC group are minor changed, as described below.
UC group: Inform the subjects about results of frailty, osteoporosis or depression assessment. The study educational booklet and CD-ROM on frailty, depression, osteoporosis, healthy diets, exercise protocols, and self-coping strategies will be given to participants. One 2-hour educational session is provided to participants to go through the booklet with demonstration of study exercise protocol. Subjects are encouraged to have balanced nutrition and regular exercises at home following the study protocol. Subjects were contacted bimonthly to check on how much they had read and watched the study material, and how well they had complied with the suggested diet and exercise protocols. However, it is at the subjects' discretion to discuss with their primary care physicians regarding the clinical interventions.
IC group: Subjects will receive all interventions provided to the UC group. Furthermore, subjects will take exercise/rehabilitation courses at the participating hospitals twice a week for 24 weeks and 6 sessions of problem solving treatment (PST). If subjects do not improve on any of the 5 indicators from the (CHSPCF), comprehensive geriatric assessments (CGAs) are applied to identify more potential modifiable factors for frailty for individualized managements.
Actual number of subjects enrolled in pilot study and 2009 study are 117 and 289 respectively and the total number of subjects enrolled in pilot study and 2009 study is 406.
- Conditions
- Frailty, Osteoporosis, Depression
- Being tested
- Exercise and nutritional integrated care, Usual care with education, Problem solving therapy (PST) integrated care
- Keywords
- Frailty, Osteoporosis, Depression
- Medical subject headings
- Frailty, Osteoporosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and nutritional integrated careBehavioural
Besides the information sharing and the educational booklets, the ENIC group subjects are invited to take a structured exercise course at the participating hospital 3 times a week for 3 months. (twice a week for 24 weeks in 2009 study) The exercise program included warm up; a range of motion, stretching, and postural-correction activities; aerobic strengthening; balance; and cool down. The research team also inquired about the subjects' dietary compliance and responded to their dietary questions during the exercise sessions.
Usual care with educationBehavioural
The study educational booklet (plus CD-ROM in 2009 study) on frailty, depression, osteoporosis, healthy diets, exercise protocols, and coping strategies are given to the participants. UC group subjects will receive a 2-hour education based on the content of study booklet including 1-hour demonstration of study exercise program in 2009 study. Subjects are contacted monthly (bimonthly in 2009 study ) for frequencies of reading this booklet and the compliance on the suggested diet and exercise protocols. Subjects are also encouraged to follow with their primary care physicians for abnormal results identified from our assessments.
Problem solving therapy (PST) integrated careBehavioural
Besides the information sharing and the educational booklets, the PSTIC group subjects will receive 6 sessions of PST (within 12 weeks in pilot study, within 24 weeks in 2009 study) aiming at solving the 'here-and-now' problems contributing to their mood-related condition and helps increase their self-efficacy. If major depressions are found, subjects are referred to their primary care physicians for further medical managements.
| Study group | Role | What they receive |
|---|---|---|
| UC group | Active comparator | Usual care with education Receives: Behavioral: Usual care with education |
| ENIC group (IC group in 2009 study) | Experimental | Exercise and nutritional integrated care Receives: Behavioral: Exercise and nutritional integrated care |
| PSTIC group (IC group in 2009 study) | Experimental | Problem solving therapy integrated care Receives: Behavioral: Problem solving therapy (PST) integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of frailty
Improvement of Cardiovascular Health Study Phenotypical Classification of Frailty (CHS_PCF) by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments.
Measured: baseline, 3, 6, and 12 months
Secondary outcomes (17)
Bone Mineral Density
Dual-emission X-ray absorptiometry (DXA) of both Hip and spine
Measured: baseline and 12 months
quality of life assessment
EQ-5D index-Taiwan utility
Measured: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
QUALEFFO_31
pain, physical function,mental function
Measured: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
barthel index
Measured: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline and 12 months
PRIME-MD (only measured in pilot study)
The Primary Care Evaluation of Mental Disorders
Measured: baseline, 3, 6, and 12 months
BDI-II (only measured in 2009 study)
Beck Depression Inventory Second Edition
Measured: baseline, 6, and 12 months
health-resource utilization
Measured: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
Original Frailty Indicators
Weight loss, Exhaustion, Low level physical activity, Slow walking speed, Weak grip strength
Measured: baseline, 3, 6, and 12 months
timed up and go
Measured: baseline, 3, 6, and 12 months
one leg stand time
Measured: baseline, 3, 6, and 12 months
dominant hand grip strength
Measured: baseline, 3, 6, and 12 months
dominant knee extension power
Measured: baseline, 3, 6, and 12 months
vitamin B12 in blood
Measured: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
vitamin D in blood
Measured: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
CRP in blood
Measured: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
testosterone in blood
Measured: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
IL-6 in blood
Measured: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionDec 2010
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 FrailtyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Ken N Kuo, M.D., Study chair, Natoinal Health Research InstitutesChing-Yu Chen, M.D., Principal investigator, Natoinal Health Research InstitutesRong-Sen Yang, M.D., Principal investigator, Natoinal Health Research InstitutesKeh-Ming Lin, M.D., Principal investigator, Natoinal Health Research InstitutesChao Agnes Hsiung, M.D., Principal investigator, Natoinal Health Research Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718432
- Sponsor's protocol ID
- EC0970301
- Status last verified
- Jun 2009
- First submitted
- 16 Jul 2008
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.
PubMed 23009149
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.
- ClinicalTrials.gov ID
- NCT00718432
- Acronym / sponsor ID
- EC0970301
- Conditions
- Frailty, Osteoporosis, Depression
- Keywords
- Frailty, Osteoporosis, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Jul 2008 (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.
Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having these conditions are associated with adverse outcome in physical health, mental health, quality of life, and daily functioning. They are associated with higher mortality rates as well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and interventions of these three geriatric syndromes are often related. Frailty is often defined as accumulations of multi-system deficiencies with increased vulnerability to multiple worse outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older adults may have positive impacts on measurements associated with not only frailty, but also depression, or osteoporosis. The objective of this proposed study is to conduct a randomized control trial (RCT) to exam the effectiveness of integrated interventions on multiple outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or osteoporosis, depression. We also plan to determine the differential effects of intervention between urban and rural area.
Detailed description
This is a three-year study. In the first year, we conducted a pilot study to test the feasibility of implementing integrated model on frailty, osteoporosis, depression, and other outcomes. Another objective is to determine optimal sample size for next level intervention in year 2 and 3 (2009 study).
Subjects are community-dwelling Taiwanese elders (65-79 years of age) living in Toufen Town in Miaoli County, Taiwan. Subjects are first screened with telephone interviews with the Chinese Canadian Study of Health and Aging _Clinical Frailty Scale (CCSHA_CFS). Eligible subjects are invited to a community hospital to be screened with the Health Study Phenotypic Classification of Frailty (CHS_PCF). Subjects scored ≥ 1 on the CHS_PCF are enrolled. With a 2 by 2 factorial design, subjects are first randomized into exercise/nutrition integrated care (ENIC) group and usual care (UC) group with education. Within each group, subjects are further randomized into problem solving therapy (PST) and usual care (UC) group with education by study care managers with pre-specified protocol. UC group subject received a study educational booklet with telephone follow up on compliance of booklet reading and suggested diet and exercise programs. Besides the booklets, ENIC group subjects received structured exercise 3 times/week with nutrition consultation as needed at hospital for 3 months while PST group subjects received 6 sessions of PST at hospital in 3 months.
Subjects were followed at 3, 6 and 12 months. Primary outcome is improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline analysis. Secondary outcomes include the physical function and performance, cognition, depression, quality of life, healthcare resource utilizations and bone-mineral density (BMD). Intention-to-treat analysis was applied.
The pilot study enrolled 117 subjects, after analysis of the preliminary results, the study protocol for the second and third year (2009 study) is modified as follows:
- The study is conducted at one urban (Wanhua) and one rural (Toufen) site with roughly 150 participants at each site.
- Convenient samples referred from participant physicians' clinics instead of the population based samples in year 1 are used to decrease administration cost.
- Telephone based first stage screening instrument will be modified and validated for face to face interview.
- Longer intervention period (6-months) than year 1.
- Interventions provided in ENIC and PSTIC groups are combined into a single integrated care (IC) group. Interventions for IC group and UC group are minor changed, as described below.
UC group: Inform the subjects about results of frailty, osteoporosis or depression assessment. The study educational booklet and CD-ROM on frailty, depression, osteoporosis, healthy diets, exercise protocols, and self-coping strategies will be given to participants. One 2-hour educational session is provided to participants to go through the booklet with demonstration of study exercise protocol. Subjects are encouraged to have balanced nutrition and regular exercises at home following the study protocol. Subjects were contacted bimonthly to check on how much they had read and watched the study material, and how well they had complied with the suggested diet and exercise protocols. However, it is at the subjects' discretion to discuss with their primary care physicians regarding the clinical interventions.
IC group: Subjects will receive all interventions provided to the UC group. Furthermore, subjects will take exercise/rehabilitation courses at the participating hospitals twice a week for 24 weeks and 6 sessions of problem solving treatment (PST). If subjects do not improve on any of the 5 indicators from the (CHSPCF), comprehensive geriatric assessments (CGAs) are applied to identify more potential modifiable factors for frailty for individualized managements.
Actual number of subjects enrolled in pilot study and 2009 study are 117 and 289 respectively and the total number of subjects enrolled in pilot study and 2009 study is 406.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UC group | Active comparator | Behavioral: Usual care with educationUsual care with education |
| ENIC group (IC group in 2009 study) | Experimental | Behavioral: Exercise and nutritional integrated careExercise and nutritional integrated care |
| PSTIC group (IC group in 2009 study) | Experimental | Behavioral: Problem solving therapy (PST) integrated careProblem solving therapy integrated care |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Scored 3-6 with the "Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese Telephone Interview Version" (Telephone Interview Version is replaced by In-Person Interview Version in 2009 study)
- Frailty index ≥ 1
Key exclusion criteria (11 listed)
- Nursing home residents
- Cannot speak any of the following three dialogues: Mandarin, Taiwanese and Haga
- Hearing impairment interfering with communication or daily activities
- Visual impairment interfering with communication or daily activities.
- Cannot complete the screening instrument with the CSHA-CFS Chinese Telephone/In-Person Interview Version
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 and nutritional integrated careBesides the information sharing and the educational booklets, the ENIC group subjects are invited to take a structured exercise course at the participating hospital 3 times a week for 3 months. (twice a week for 24 weeks in 2009 study) The exercise program included warm up; a range of motion, stretching, and postural-correction activities; aerobic strengthening; balance; and cool down. The research team also inquired about the subjects' dietary compliance and responded to their dietary questions during the exercise sessions. | Behavioural | ENIC group (IC group in 2009 study) |
| Usual care with educationThe study educational booklet (plus CD-ROM in 2009 study) on frailty, depression, osteoporosis, healthy diets, exercise protocols, and coping strategies are given to the participants. UC group subjects will receive a 2-hour education based on the content of study booklet including 1-hour demonstration of study exercise program in 2009 study. Subjects are contacted monthly (bimonthly in 2009 study ) for frequencies of reading this booklet and the compliance on the suggested diet and exercise protocols. Subjects are also encouraged to follow with their primary care physicians for abnormal results identified from our assessments. | Behavioural | UC group |
| Problem solving therapy (PST) integrated careBesides the information sharing and the educational booklets, the PSTIC group subjects will receive 6 sessions of PST (within 12 weeks in pilot study, within 24 weeks in 2009 study) aiming at solving the 'here-and-now' problems contributing to their mood-related condition and helps increase their self-efficacy. If major depressions are found, subjects are referred to their primary care physicians for further medical managements. | Behavioural | PSTIC group (IC group in 2009 study) |
Primary outcome
improvement of frailty
Time frame: baseline, 3, 6, and 12 months
Improvement of Cardiovascular Health Study Phenotypical Classification of Frailty (CHS_PCF) by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments.
17 secondary outcomes
Bone Mineral Density
Time frame: baseline and 12 months
quality of life assessment
Time frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
QUALEFFO_31
Time frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
barthel index
Time frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline and 12 months
PRIME-MD (only measured in pilot study)
Time frame: baseline, 3, 6, and 12 months
BDI-II (only measured in 2009 study)
Time frame: baseline, 6, and 12 months
health-resource utilization
Time frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
Original Frailty Indicators
Time frame: baseline, 3, 6, and 12 months
timed up and go
Time frame: baseline, 3, 6, and 12 months
one leg stand time
Time frame: baseline, 3, 6, and 12 months
dominant hand grip strength
Time frame: baseline, 3, 6, and 12 months
dominant knee extension power
Time frame: baseline, 3, 6, and 12 months
vitamin B12 in blood
Time frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
vitamin D in blood
Time frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
CRP in blood
Time frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
testosterone in blood
Time frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
IL-6 in blood
Time frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
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 25 Jun 2015.
- Derived from this study: PubMed 23009149Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.
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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.
Ken N Kuo, M.D. study chair
Natoinal Health Research Institutes
Ching-Yu Chen, M.D. principal investigator
Natoinal Health Research Institutes
Rong-Sen Yang, M.D. principal investigator
Natoinal Health Research Institutes
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 and nutritional integrated care and Problem solving therapy (PST) integrated care in people with Frailty and Osteoporosis, run by National Health Research Institutes, Taiwan 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 11 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 25 Jun 2015. 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. 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?
improvement of frailty (time frame: baseline, 3, 6, and 12 months). 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 NCT00718432, 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 25 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.