Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP

February 27, 2025 updated by: Universitas Padjadjaran

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:

  1. Do global DNA methylation levels change in elderly people in Bandung after receiving modified poco-poco exercise?
  2. Do GDF15 levels change in elderly people in Bandung after they are given modified poco-poco exercise?
  3. Do lamin A COP levels change in elderly people in Bandung after they are given modified poco-poco exercise?
  4. 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Indonesia
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40287
        • Recruiting
        • Puskesmas Sekejati
        • Contact:
          • MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Frailty level is in pre-frailty
  2. MoCA INA score above 18
  3. Domicile in Bandung City
  4. Willing to participate in the study after informed consent

Exclusion Criteria:

  1. There is a hearing impairment that may prevent the subject from receiving verbal instructions
  2. There is uncorrected visual impairment
  3. There are musculoskeletal disorders so that they cannot perform exercise procedures or procedures for measuring research variables
  4. Subjects received other rehabilitation programs
  5. Post-stroke with average limb muscle strength below three
  6. There are diseases that cause impaired cognition such as Alzheimer's disease, traumatic head injury, Parkinson's disease.
  7. 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.
  8. Severe cardiovascular disease as assessed by a heart and vascular specialist
  9. Unable to attend Exercises regularly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Frail elderly living in community
Adult above 60 years old, frailty level based on Fried frailty phenotype, without having diabetes mellitus and cardiac disease
Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Exercise training that consists of flexibility, aerobic, balance and strengthening regime. The exercise given three times a week, for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 ...
week 0 and week 12
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
week 0 and week 12
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
week 0 and week 12
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.
week 0 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitas Padjadjaran

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indonesia Endowment Fund for Education Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Irma R. Defi, DR. Med. Sc, dr, SpKFR, Ger(K), Faculty of Medicine Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IKFR-202410.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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