Clinical trial NCT06628895: Effect of Modified Poco-Poco Exercise to Frailty Stages, Expression of Global DNA Methylation, GDF15 and Lamin A COP
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frail Elderly
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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

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.

Eligibility criteria: 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\&#39;s disease, traumatic head injury, Parkinson\&#39;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

Primary outcomes:
measure: Change From Baseline in Level of Global DNA Methylation in 12 Weeks
timeFrame: week 0 and week 12
measure: Change From Baseline in Level of Growth Deficiency Factor (GDF15) in 12 Weeks
timeFrame: week 0 and week 12
measure: Change From Baseline in Level of Lamin A (Cyclic Osteo Progenitor) COP in 12 Weeks
timeFrame: week 0 and week 12
measure: Change From Baseline in Level of Frailty in 12 Weeks
timeFrame: week 0 and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Puskesmas Sekejati
state: Jawa Barat
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran
name: Irma R. Defi, DR. Med. Sc, dr, SpKFR, Ger(K)
role: STUDY_DIRECTOR
References: