FrailtyNCT05511311
Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:
A study testing Resistance Training and Standard Therapy in people with Frailty and Sarcopenia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
There is an increasing number of elderly population, not only in Indonesia, but also in the world. With increasing of age, there is also an increasing number of elderly with sarcopenia and frailty. Both of the diseases can lead to dependency, decrease quality of life, and morbidity. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia, Resistance Training
- What is being tested?
- Resistance Training and Standard Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2022to 30 Nov 2022
- 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
- Patients 60 years old or orlder
- Categorized as Pre-frail or Frail based on FRAIL criteria
- Is not in routine physical activity in the past 3 months
- Succeeded Mini Physical Performance Test with score 11 or more
Who cannot join
- Cognitive Disturbance (Abbreviated Mental Test < 8)
- Not consenting to join the trial
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo National Hospital
Jakarta, Jakarta Pusat, 10310
Siti Setiati, Prof, 081389835588, s_setiati@yahoo.com
Rahmi Istanti, 081519745728, rahmiistanti77@gmail.com
About this study
Official title: Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM: The Role of Resistance Training as Sarcopenia and Frailty Management Towards Frailty Score, Sarcopenia Score, and Quality of Life
There is an increasing number of elderly population, not only in Indonesia, but also in the world. With increasing of age, there is also an increasing number of elderly with sarcopenia and frailty. Both of the diseases can lead to dependency, decrease quality of life, and morbidity. Besides nutrition, physical activity, especially resistance training is proven to be beneficial in improving sarcopenia and frailty condition.
Currently in Cipto Mangunkusumo National Hospital (RSCM), there is no comprehensive frailty prevention clinic in the geriatric inpatient clinics. This research can be the base of frailty and sarcopenia treatment in RSCM.
- Conditions
- Frailty, Sarcopenia, Resistance Training
- Being tested
- Resistance Training, Standard Therapy
- Keywords
- frailty, sarcopenia, elderly, resistance training
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingProcedure or surgery
Resistance training developed by the researcher (SCR-RSCM) for 12 weeks
Standard TherapyProcedure or surgery
Standard therapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 12-week of Standard Therapy using elastic-band Receives: Procedure: Standard Therapy |
| Intervention | Experimental | 12-week of Resistance Training developed by RSCM using sand-bag Receives: Procedure: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Status
The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight (10). Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
Measured: 12 weeks
Sarcopenia Status
Measured using:
- BIA: <7.0 kg/m2 in men and <5.7 kg/m2 in women
- Five times sit to stand: ≥12 seconds
- Hand-grip strength: <28 kg for men and <18 kg for women
Measured: 12 weeks
Walking Speed
<1.0 m/s
Measured: 12 weeks
Patient's Quality of Life
Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')
Measured: 12 weeks
Secondary outcomes (2)
Prevalence of Frailty
The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight (10). Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
Measured: 12 weeks
Prevalence of Sarcopenia
Measured using:
- BIA: <7.0 kg/m2 in men and <5.7 kg/m2 in women
- Five times sit to stand: ≥12 seconds
- Hand-grip strength: <28 kg for men and <18 kg for women
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 posted22 Aug 2022
- Study start1 Jan 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Setiati, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511311
- Sponsor's protocol ID
- Frailty Clinic
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 32033882Mienche M, Setiati S, Setyohadi B, Kurniawan J, Laksmi PW, Ariane A, Tirtarahardja G. Diagnostic Performance of Calf Circumference, Thigh Circumference, and SARC-F Questionnaire to Identify Sarcopenia in Elderly Compared to Asian Working Group for Sarcopenia's Diagnostic Standard. Acta Med Indones. 2019 Apr;51(2):117-127.
PubMed 31383826Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM: The Role of Resistance Training as Sarcopenia and Frailty Management Towards Frailty Score, Sarcopenia Score, and Quality of Life
- ClinicalTrials.gov ID
- NCT05511311
- Acronym / sponsor ID
- Frailty Clinic
- Conditions
- Frailty, Sarcopenia, Resistance Training
- Keywords
- frailty, sarcopenia, elderly, resistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 22 Aug 2022 (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.
There is an increasing number of elderly population, not only in Indonesia, but also in the world. With increasing of age, there is also an increasing number of elderly with sarcopenia and frailty. Both of the diseases can lead to dependency, decrease quality of life, and morbidity. Besides nutrition, physical activity, especially resistance training is proven to be beneficial in improving sarcopenia and frailty condition.
Currently in Cipto Mangunkusumo National Hospital (RSCM), there is no comprehensive frailty prevention clinic in the geriatric inpatient clinics. This research can be the base of frailty and sarcopenia treatment in RSCM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Standard Therapy12-week of Standard Therapy using elastic-band |
| Intervention | Experimental | Procedure: Resistance Training12-week of Resistance Training developed by RSCM using sand-bag |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 60 years old or orlder
- Categorized as Pre-frail or Frail based on FRAIL criteria
- Is not in routine physical activity in the past 3 months
- Succeeded Mini Physical Performance Test with score 11 or more
Key exclusion criteria (2 listed)
- Cognitive Disturbance (Abbreviated Mental Test < 8)
- Not consenting to join the trial
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 |
|---|---|---|
| Resistance TrainingResistance training developed by the researcher (SCR-RSCM) for 12 weeks | Procedure or surgery | Intervention |
| Standard TherapyStandard therapy for 12 weeks | Procedure or surgery | Control |
Primary outcome
Frailty Status
Time frame: 12 weeks
The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight (10). Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status
Sarcopenia Status
Time frame: 12 weeks
Measured using: * BIA: <7.0 kg/m2 in men and <5.7 kg/m2 in women * Five times sit to stand: ≥12 seconds * Hand-grip strength: <28 kg for men and <18 kg for women
Walking Speed
Time frame: 12 weeks
<1.0 m/s
Patient's Quality of Life
Time frame: 12 weeks
Measured by EQ-5D: ranging from 0 ('worst imaginable health') to 100 ('best imaginable health')
2 secondary outcomes
Prevalence of Frailty
Time frame: 12 weeks
Prevalence of Sarcopenia
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Results publication: 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.
- Results publication: PubMed 31383826Mienche M, Setiati S, Setyohadi B, Kurniawan J, Laksmi PW, Ariane A, Tirtarahardja G. Diagnostic Performance of Calf Circumference, Thigh Circumference, and SARC-F Questionnaire to Identify Sarcopenia in Elderly Compared to Asian Working Group for Sarcopenia's Diagnostic Standard. Acta Med Indones. 2019 Apr;51(2):117-127.
- Results publication: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Standard Therapy in people with Frailty and Sarcopenia, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Status (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 NCT05511311, which also lists 3 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 22 Aug 2022.