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NCT Number: NCT06628895

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

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

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Key information

Conditions

Frail Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas Sekejati

Bandung, West Java, 40287, Indonesia

Location status: Recruiting

Location contact

MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Frailty level is in pre-frailty
  • MoCA INA score above 18
  • Domicile in Bandung City
  • Willing to participate in the study after informed consent

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Other

Exercise training that consists of flexibility, aerobic, balance and strengthening regime. The exercise given three times a week, for 12 weeks.

Primary outcomes

  1. 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 ...

  2. 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

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Istingadah Desiana, dr, SpKFR, Ger(K), FIPM (USG)

CONTACT

[email protected]

62 812 7123 9200

William Giovani, dr

CONTACT

[email protected]

6281271239200

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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