Frail ElderlyNCT06628895
Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Frail Elderly, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to know the effect of multicomponent exercise in frail elderly in community to aging hallmarks. The main question[s] it aims to answer are: 1. Do global DNA methylation levels change in elderly people in Bandung after receiving modified poco-poco exercise? 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Sep 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Frailty level is in pre-frailty
- MoCA INA score above 18
- Domicile in Bandung City
- Willing to participate in the study after informed consent
Who cannot join
- There is a hearing impairment that may prevent the subject from receiving verbal instructions
- There is uncorrected visual impairment
- There are musculoskeletal disorders so that they cannot perform exercise procedures or procedures for measuring research variables
- Subjects received other rehabilitation programs
- Post-stroke with average limb muscle strength below three
- There are diseases that cause impaired cognition such as Alzheimer\'s disease, traumatic head injury, Parkinson\'s disease.
Show all 9Show fewer
- There are severe joint diseases such as osteoarthritis and rheumatoid arthritis that may worsen during exercise or may cause difficulty in carrying out the exercise program.
- Severe cardiovascular disease as assessed by a heart and vascular specialist
- Unable to attend Exercises regularly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Istingadah Desiana, dr, SpKFR, Ger(K), FIPM (USG) contact
Indonesia1 site, 1 recruiting
- Recruiting
Puskesmas Sekejati
Bandung, West Java, 40287
MD
About this study
Official title: Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP on Elderly Living On Community in Bandung
The goal of this clinical trial is to know the effect of multicomponent exercise in frail elderly in community to aging hallmarks. The main question[s] it aims to answer are:
- Do global DNA methylation levels change in elderly people in Bandung after receiving modified poco-poco exercise?
- Do GDF15 levels change in elderly people in Bandung after they are given modified poco-poco exercise?
- Do lamin A COP levels change in elderly people in Bandung after they are given modified poco-poco exercise?
- Does the level of frailty in elderly people in Bandung change after they are given modified poco-poco exercise?
Participants will be asked to do flexibility, balance, aerobic and strengthening exercise included in poco-poco modified exercise three times a week for 12 weeks
Read the detailed description
The elderly population in West Java Province with the age category of 60-64 years is 1.76 million people. Experts estimate that 25.2% of the Indonesian population experiences frailty. Frailty can lead to a variety of worsening health conditions. The frailty process is thought to stem from the failure of various mechanisms associated with markers of aging. Markers of aging are divided into three categories: primary, antagonistic and integrative. Biomarkers representing these three categories are global DNA methylation, GDF15 and Lamin A COP. Multicomponent exercise is the most effective intervention in elderly with frailty. Elderly people in West Java on average only have an education equivalent to junior high school (SMP), so activities that promote physical activity are better focused on health activities in the community. The poco-poco exercise that is currently commonly practiced almost fulfills the rules of multicomponent exercise for frailty elderly, but poco-poco exercise does not have a muscle strengthening exercise component, so a modified poco-pcoco exercise was created to fulfill this method.
- Conditions
- Frail Elderly
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
Exercise training that consists of flexibility, aerobic, balance and strengthening regime. The exercise given three times a week, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Frail elderly living in community | Experimental | Adult above 60 years old, frailty level based on Fried frailty phenotype, without having diabetes mellitus and cardiac disease Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Level of Global DNA Methylation in 12 Weeks
Global DNA Methylation will be measured twice using ...
Measured: week 0 and week 12
Change From Baseline in Level of Growth Deficiency Factor (GDF15) in 12 Weeks
GDF15 will be measured using blood plasma with Enzyme Linked Immuno Assay (ELISA), expected GDF value that show improvement that it will be decreased
Measured: week 0 and week 12
Change From Baseline in Level of Lamin A (Cyclic Osteo Progenitor) COP in 12 Weeks
Lamin A COP will be measured with flow cytometry from Peripheral Blood Mononuclear Cells (PBMC), the value that shows improvement has a lesser lamin A COP population
Measured: week 0 and week 12
Change From Baseline in Level of Frailty in 12 Weeks
Level of Frailty is measured using Fried's Frailty Phenotype with range 1-5 with 5 is the worst level of frailty. Fried's frailty measured with five components that are unintentional weight loss, muscle weakness, exhaustion on activity, slow gait and low physical activity.
Measured: week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Sep 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irma R. Defi, DR. Med. Sc, dr, SpKFR, Ger(K), Study director, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628895
- Sponsor's protocol ID
- IKFR-202410.01
- Status last verified
- Feb 2025
- First submitted
- 26 Sep 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP on Elderly Living On Community in Bandung
- ClinicalTrials.gov ID
- NCT06628895
- Acronym / sponsor ID
- IKFR-202410.01
- Conditions
- Frail Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 8 Oct 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.
The goal of this clinical trial is to know the effect of multicomponent exercise in frail elderly in community to aging hallmarks. The main question[s] it aims to answer are:
- Do global DNA methylation levels change in elderly people in Bandung after receiving modified poco-poco exercise?
- Do GDF15 levels change in elderly people in Bandung after they are given modified poco-poco exercise?
- Do lamin A COP levels change in elderly people in Bandung after they are given modified poco-poco exercise?
- Does the level of frailty in elderly people in Bandung change after they are given modified poco-poco exercise?
Participants will be asked to do flexibility, balance, aerobic and strengthening exercise included in poco-poco modified exercise three times a week for 12 weeks
Detailed description
The elderly population in West Java Province with the age category of 60-64 years is 1.76 million people. Experts estimate that 25.2% of the Indonesian population experiences frailty. Frailty can lead to a variety of worsening health conditions. The frailty process is thought to stem from the failure of various mechanisms associated with markers of aging. Markers of aging are divided into three categories: primary, antagonistic and integrative. Biomarkers representing these three categories are global DNA methylation, GDF15 and Lamin A COP. Multicomponent exercise is the most effective intervention in elderly with frailty. Elderly people in West Java on average only have an education equivalent to junior high school (SMP), so activities that promote physical activity are better focused on health activities in the community. The poco-poco exercise that is currently commonly practiced almost fulfills the rules of multicomponent exercise for frailty elderly, but poco-poco exercise does not have a muscle strengthening exercise component, so a modified poco-pcoco exercise was created to fulfill this method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail elderly living in community | Experimental | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAdult above 60 years old, frailty level based on Fried frailty phenotype, without having diabetes mellitus and cardiac disease |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Frailty level is in pre-frailty
- MoCA INA score above 18
- Domicile in Bandung City
- Willing to participate in the study after informed consent
Key exclusion criteria (9 listed)
- There is a hearing impairment that may prevent the subject from receiving verbal instructions
- There is uncorrected visual impairment
- There are musculoskeletal disorders so that they cannot perform exercise procedures or procedures for measuring research variables
- Subjects received other rehabilitation programs
- Post-stroke with average limb muscle strength below three
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 TRAINING WITH OR WITHOUT MEDICATIONExercise training that consists of flexibility, aerobic, balance and strengthening regime. The exercise given three times a week, for 12 weeks. | Other | Frail elderly living in community |
Primary outcome
Change From Baseline in Level of Global DNA Methylation in 12 Weeks
Time frame: week 0 and week 12
Global DNA Methylation will be measured twice using ...
Change From Baseline in Level of Growth Deficiency Factor (GDF15) in 12 Weeks
Time frame: week 0 and week 12
GDF15 will be measured using blood plasma with Enzyme Linked Immuno Assay (ELISA), expected GDF value that show improvement that it will be decreased
Change From Baseline in Level of Lamin A (Cyclic Osteo Progenitor) COP in 12 Weeks
Time frame: week 0 and week 12
Lamin A COP will be measured with flow cytometry from Peripheral Blood Mononuclear Cells (PBMC), the value that shows improvement has a lesser lamin A COP population
Change From Baseline in Level of Frailty in 12 Weeks
Time frame: week 0 and week 12
Level of Frailty is measured using Fried's Frailty Phenotype with range 1-5 with 5 is the worst level of frailty. Fried's frailty measured with five components that are unintentional weight loss, muscle weakness, exhaustion on activity, slow gait and low physical activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Frail Elderly
RecruitingPhase 2
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Diffuse Large B-Cell Lymphoma
RecruitingPhase 2
Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%
Metastatic NSCLC - Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of a Fitness-adapted Thera-py Approach With Either Continuous Zanubrutinib Monotherapy or Time-limited Zanubrutinib + Sonrotoclax in Older and/or Frail Patients With Treatment-naïve CLL
CLL (Chronic Lymphocytic Leukemia)
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Recruiting
Frailty Training for Emergency Nurses: A Cluster RCT in Morocco
Frail Elderly, Frailty
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.
Istingadah Desiana, dr, SpKFR, Ger(K), FIPM (USG) contact
Irma R. Defi, DR. Med. Sc, dr, SpKFR, Ger(K) study director
Universitas Padjadjaran
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 TRAINING WITH OR WITHOUT MEDICATION in people with Frail Elderly, run by Universitas Padjadjaran 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 9 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: looking for participants now, as of the sponsor's last update on 4 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Istingadah Desiana, dr, SpKFR, Ger(K), FIPM (USG) (62 812 7123 9200, istingadah.desiana@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Level of Global DNA Methylation in 12 Weeks (time frame: week 0 and week 12). 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?
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 4 Mar 2025.