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Completed

NCT Number: NCT07300722

Impact of "SI Kumbang" Gymnastic Exercise on Physical Performance and Immunity in the Elderly

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.

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Key information

Conditions

Healthy

Age range

60 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Muhammadiyah Jakarta

Jakarta, DKI Jakarta, 13220, Indonesia

About this study

A sample size of 33 people per group was determined. The study supervisor oversaw the use of a basic randomization program to carry out the random allocation. The Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) technique was used to guarantee allocation concealment. Outcome assessors were subjected to single blinding; they were not told about group allocations and were not allowed to look for relevant information. The "SI Kumbang" 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 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.

The research team reviewed patient logbooks at the beginning of each week to track adverse effects such weariness, shortness of breath, pain, or dizziness. At RS Islam Jakarta Pondok Kopi, every suspected adverse event was swiftly assessed, and any required medical attention was given. Every adverse event was reported to the ethics committee of the institution.

Data analysis was performed using SPSS 29.0 tests with significance set at p<0.05. Descriptive summaries of the sample characteristics were provided. Prior to analysis, the normality of the data was checked. Dependent t-tests were used to compare pre intervention and post intervention score in the SI Kumbang and Bugar Lansia groups for normally distributed outcomes (6MWD, handgrip, SPPB, PASE, Caspase-1, IL-18); the Wilcoxon test was used to assess non-normal data. Independent t test or Mann-Whitney U test is used for compared the effectiveness of the two interventions (∆ score). A p-value of less than 0.05 was deemed significant.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

SI Kumbang gymnastic exercise

Other

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

Bugar Lansia Gymnastic Exercise

Other

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

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 12 weeks.

    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).

  2. Strength muscle as Assessed by handgrip JAMAR

    Time frame: From enrollment to the end of treatment at 12 weeks.

    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.

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

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

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

    Time frame: From enrollment to the end of treatment at 12 weeks.

    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.

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

    Time frame: From enrollment to the end of treatment at 12 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Umi Sjarqiah

Other

Collaborators

  • Fakultas Kedokteran Universitas Indonesia
  • Fakultas Kedokteran dan Kesehatan Universitas Muhammadiyah Jakarta

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2025
Registry last updated
Dec 24, 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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