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

U

Umi Sjarqiah

Status

Completed

Conditions

Healthy

Treatments

Other: SI Kumbang gymnastic exercise
Other: Bugar Lansia Gymnastic Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07300722
24-10-1593

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

Female

Ages

60 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

SI Kumbang Gymnastic Exercise
Experimental group
Description:
Intervention Group received SI Kumbang gymnastic exercise
Treatment:
Other: SI Kumbang gymnastic exercise
Bugar Lansia Gymnastic Exercise
Active Comparator group
Description:
Controlled Group received Bugar Lansia gymnastic exercise
Treatment:
Other: Bugar Lansia Gymnastic Exercise

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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