NCT07300722

Brief Summary

The goal of this clinical trial is to evaluate and compare the impact of SI Kumbang gymnastic exercise and Bugar Lansia gymnastic exercise programs on physical performance dan immunity in elderly. It will also learn about the safety of SI Kumbang gymnastic exercise. The main questions it aims to answer are:

  • How does cardiorespiratory fitness differ between SI Kumbang and Bugar Lansia exercise?
  • How does muscle strength differ between SI Kumbang and Bugar Lansia exercise?
  • How does balance differ between SI Kumbang and Bugar Lansia exercise?
  • How does physical activity differ between SI Kumbang and Bugar Lansia exercise?
  • How do Caspase-1 and IL-18 inflammasomes differ between SI Kumbang and Bugar Lansia exercise? Researchers will compare SI Kumbang gymnastic exercise to a Bugar Lansia gymnastic exercise to see if SI Kumbang gymnastic exercise better than Bugar Lansia gymnastic exercise. Participants will:
  • Do SI Kumbang gymnastic exercise or Bugar Lansia gymnastic exercise a within 3 times a week for 3 months.
  • Visit the clinic twice for outcome assesment before and after intervention.
  • Keep a diary of their symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 19, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

physical performanceimmunitySI Kumbang exercise gymnasticselderly

Outcome Measures

Primary Outcomes (5)

  • Cardiorespiration endurance as Assessed by Six-Minute Walk Distance (6MWD)

    The definition of Six Minute Walking Distance (6MWD) is a 15-meter walking test for 6 minutes which is one of the sub-maximal tests, namely O2 uptake and heart rate are linearly related to VO2max so that fitness can be predicted. During the exercise, respondents are not allowed to run and respondents are allowed to rest during the test. This is an appropriate method because it has been proven to be able to achieve the sub-maximal zone and aerobic zone in a person. The results taken are the distance traveled in meters (Six Minutes Walking Distance).

    From enrollment to the end of treatment at 12 weeks.

  • Strength muscle as Assessed by handgrip JAMAR

    A Jamar is a handheld dynamometer used to measure the maximal strength of the hand and forearm muscles through an isometric grip test. It assesses the strength of the muscles primarily responsible for closing the fingers and gripping, such as the forearm flexors. The test involves a standardized procedure, and the results are displayed on a dual scale in kilograms and pounds, often with a peak-hold needle to record the highest force achieved.

    From enrollment to the end of treatment at 12 weeks.

  • Balance as Assessed by Short Physical Performance Battery (SPPB).

    The Short Physical Performance Battery (SPPB) is an objective assessment tool used to evaluate the physical function of an older person's lower extremities. It is comprised of three simple tasks: a timed chair stand test, a timed gait speed test, and a standing balance test. The results from these tests are combined into a score from 0 (worst) to 12 (best), which is used to predict various health outcomes such as disability, hospitalization, and mortality.

    From enrollment to the end of treatment at 12 weeks

  • Physical activity as Assessed by Physical Activity Scale for the Elderly (PASE).

    The Physical Activity Scale for the Elderly (PASE) is a brief, self-report questionnaire that assesses the level of physical activity in adults aged 65 and older over a one-week period. It includes questions about frequency and duration of leisure, household, and work-related activities and can be administered through telephone, mail, or in-person interviews. Higher scores indicate a greater amount of physical activity.

    From enrollment to the end of treatment at 12 weeks.

  • Immunity were inflammasome as Assessed by Caspase-1 and IL-18.

    Caspase-1 is an enzyme that activates the proinflammatory cytokines interleukin-1 beta (IL-1β) and interleukin-18 (IL-18) by processing them into their mature, active forms. This process is a key part of the body's inflammatory response to infections and stress.

    From enrollment to the end of treatment at 12 weeks.

Study Arms (2)

SI Kumbang Gymnastic Exercise

EXPERIMENTAL

Intervention Group received SI Kumbang gymnastic exercise

Other: SI Kumbang gymnastic exercise

Bugar Lansia Gymnastic Exercise

ACTIVE COMPARATOR

Controlled Group received Bugar Lansia gymnastic exercise

Other: Bugar Lansia Gymnastic Exercise

Interventions

SI Kumbang Gymnastic Exercise with four-way leg movements with hand movements using barbell weights and medium-intensity music.

SI Kumbang Gymnastic Exercise

Bugar Lansia Gymnastic Exercise with one-way forward leg movements with hand movements without barbell weights with medium intensity music.

Bugar Lansia Gymnastic Exercise

Eligibility Criteria

Age60 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants
  • Age of 60 to 70 years old.
  • Categorized as pre-frail (FI-40 score \> 0.08 \< 0.25) or robust (FI-40 score ≤ 0.08)
  • Body mass index (BMI) between 18.5 and 24.9.
  • Diabetes mellitus (controlled glucose ≤ 120 mg/dL)
  • Blood pressure (controlled blood tension ≤ 130/80 mmHg) without taking any drugs that affected heart rate.

You may not qualify if:

  • Chronic heart or lung disease conditions
  • Chronic conditions that cannot be reversed (e.g., cancer or chronic renal disease)
  • Diabetes complications in the extremities
  • Motor impairment (MMT \< 5)
  • Knee pain
  • Lower limb deformities (genu varus/valgus)
  • Hand deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Muhammadiyah Jakarta

Jakarta, DKI Jakarta, 13220, Indonesia

Location

Study Officials

  • Umi Sjarqiah, Medical Doctor

    University of Muhammadiyah Jakarta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The SI Kumbang gymnastics exercise and Bugar Lansia gymnastics exercise regimens were part of the intervention groups. For 12 weeks in a row, both therapies included three 30-minute sessions, 3 times per week. Participants received adaption sessions to acquaint themselves with the workout regimens throughout the first week. The Borg Scale was utilized to track intensity.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 24, 2025

Study Start

April 1, 2025

Primary Completion

September 10, 2025

Study Completion

September 30, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations