HealthyNCT07300722
Impact of "SI Kumbang" Gymnastic Exercise on Physical Performance and Immunity in the Elderly
A study testing SI Kumbang gymnastic exercise and Bugar Lansia Gymnastic Exercise in people with Healthy, run by Umi Sjarqiah at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SI Kumbang gymnastic exercise and Bugar Lansia Gymnastic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
University of Muhammadiyah Jakarta
Jakarta, DKI Jakarta, 13220
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- SI Kumbang gymnastic exercise, Bugar Lansia Gymnastic Exercise
- Keywords
- physical performance, immunity, SI Kumbang exercise gymnastics, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI Kumbang gymnastic exerciseOther
SI Kumbang Gymnastic Exercise with four-way leg movements with hand movements using barbell weights and medium-intensity music.
Bugar Lansia Gymnastic ExerciseOther
Bugar Lansia Gymnastic Exercise with one-way forward leg movements with hand movements without barbell weights with medium intensity music.
| Study group | Role | What they receive |
|---|---|---|
| SI Kumbang Gymnastic Exercise | Experimental | Intervention Group received SI Kumbang gymnastic exercise Receives: Other: SI Kumbang gymnastic exercise |
| Bugar Lansia Gymnastic Exercise | Active comparator | Controlled Group received Bugar Lansia gymnastic exercise Receives: Other: Bugar Lansia Gymnastic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Apr 2025
- Primary completion10 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umi Sjarqiah
- Sponsor type
- University, hospital or other
- Collaborators
- Muhammadiyah University of Jakarta, Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Sponsor-investigator, Umi Sjarqiah, Universitas Muhammadiyah Yogyakarta
- Investigators
- Umi Sjarqiah, Medical Doctor, Principal investigator, University of Muhammadiyah Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300722
- Sponsor's protocol ID
- 24-10-1593
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of "SI Kumbang" Gymnastic Exercise on Physical Performance and Immunity in the Elderly
- ClinicalTrials.gov ID
- NCT07300722
- Acronym / sponsor ID
- 24-10-1593
- Conditions
- Healthy
- Keywords
- physical performance, immunity, SI Kumbang exercise gymnastics, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Umi SjarqiahUniversity, hospital or other
- Collaborators
- Muhammadiyah University of Jakarta, Fakultas Kedokteran Universitas Indonesia
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SI Kumbang Gymnastic Exercise | Experimental | Other: SI Kumbang gymnastic exerciseIntervention Group received SI Kumbang gymnastic exercise |
| Bugar Lansia Gymnastic Exercise | Active comparator | Other: Bugar Lansia Gymnastic ExerciseControlled Group received Bugar Lansia gymnastic exercise |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SI Kumbang gymnastic exerciseSI Kumbang Gymnastic Exercise with four-way leg movements with hand movements using barbell weights and medium-intensity music. | Other | SI Kumbang Gymnastic Exercise |
| Bugar Lansia Gymnastic ExerciseBugar Lansia Gymnastic Exercise with one-way forward leg movements with hand movements without barbell weights with medium intensity music. | Other | Bugar Lansia Gymnastic Exercise |
Primary outcome
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umi Sjarqiah, Medical Doctor principal investigator
University of Muhammadiyah Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SI Kumbang gymnastic exercise and Bugar Lansia Gymnastic Exercise in people with Healthy, run by Umi Sjarqiah at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiration endurance as Assessed by Six-Minute Walk Distance (6MWD) (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.