NCT06628895

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

September 26, 2024

Last Update Submit

February 27, 2025

Conditions

Frail Elderly

Outcome Measures

Primary Outcomes (4)

  • Change From Baseline in Level of Global DNA Methylation in 12 Weeks

    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

    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

    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

    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

Study Arms (1)

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

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

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.

Frail elderly living in community

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas Sekejati

Bandung, West Java, 40287, Indonesia

RECRUITING

MeSH Terms

Interventions

ExerciseDosage Forms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Irma R. Defi, DR. Med. Sc, dr, SpKFR, Ger(K)

    Faculty of Medicine Universitas Padjadjaran

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

62 812 7123 9200istingadah.desiana@unpad.ac.id

William Giovani, dr

CONTACT

6281271239200williamgiovanni146@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 8, 2024

Study Start

September 15, 2024

Primary Completion

March 15, 2025

Study Completion

April 30, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)