Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fakultas Kedokteran dan Kesehatan Universitas Muhammadiyah Jakarta | OTHER |
| Fakultas Kedokteran Universitas Indonesia | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI Kumbang Gymnastic Exercise | Experimental | Intervention Group received SI Kumbang gymnastic exercise |
|
| Bugar Lansia Gymnastic Exercise | Active Comparator | Controlled Group received Bugar Lansia gymnastic exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI Kumbang gymnastic exercise | Other | SI Kumbang Gymnastic Exercise with four-way leg movements with hand movements using barbell weights and medium-intensity music. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Umi Sjarqiah, Medical Doctor | University of Muhammadiyah Jakarta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Muhammadiyah Jakarta | Jakarta | DKI Jakarta | 13220 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2025 | Dec 17, 2025 | Prot_SAP_000.pdf |
Not provided
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.
Not provided
Not provided
Not provided
| 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. |
|
| 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. |