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Completed

NCT Number: NCT07149272

Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients

The goal of this clinical trial is to determine whether adding virtual reality exercise to conventional multimodal exercise affects exercise-related lactate kinetics, functional status, frailty, sarcopenia risk, perceived exertion, and health-related quality of life in adults aged 60 years or older who are hospitalized in an acute geriatric ward.

The main questions it aims to answer are:

1. are there any difference in post exercise lactate at day 1 and 7 between the two groups? 2. does the lactate concentration reduces after low intensity resistance exercise in subject with high resting lactate? 3. Does virtual reality-assisted multimodal exercise improve functional independence, frailty status, sarcopenia risk, perceived exertion, and health-related quality of life from baseline to Day 7?

Researchers will compare participants receiving conventional multimodal exercise plus virtual reality exercise with participants receiving conventional multimodal exercise alone to evaluate the additional effects of the virtual reality intervention.

Participants will:

* Undergo functional and medical assessments before starting the exercise program. * Receive an individualized conventional multimodal exercise program during hospitalization. * If assigned to the intervention group, perform additional virtual reality exercise using the VRAGMENT program. * Have capillary blood lactate concentrations measured immediately before and after standardized low-intensity resistance exercise on Day 1 and Day 7. * Complete the following assessments at baseline and on Day 7: * Barthel Index to assess functional independence. * Frailty Index-40 (FI-40) to assess frailty. * SARC-F to assess the risk of sarcopenia. * Borg Rating of Perceived Exertion (RPE) Scale to assess perceived exercise intensity. * EQ-5D-5L to assess health-related quality of life. * Have vital signs, exercise tolerance, and adverse events monitored throughout the intervention.

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Key information

Conditions

Fatigue Atrophy Behavior Frailty Lactate Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Quality of Life Sarcopenia Sarcopenia in Elderly Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

153 hospitalized older adults were enrolled from the acute geriatric ward at RSUPN Dr. Cipto Mangunkusumo (RSCM). Participants were randomly allocated to either a control group or an intervention group. The control group received conventional multimodal exercise, while the intervention group received the same conventional exercise program with additional virtual reality exercise (VRE) as an adjunctive therapy.

Before beginning the exercise program, each participant underwent a comprehensive medical and functional assessment performed by a physical medicine and rehabilitation specialist. An individualized exercise prescription was then developed according to the participant's clinical and functional condition. The prescription specified the frequency, intensity, duration, and type of exercise. Conventional multimodal exercise could include breathing, resistance, aerobic, mobility, and other clinically indicated exercises.

Participants assigned to the intervention group additionally performed VRE using the VRAGMENT software. VRAGMENT simulates instrumental activities of daily living, including making telephone calls, selecting grocery items, and completing payment transactions. Activities performed in the virtual environment were designed to elicit movements of the neck, trunk, upper limbs, and lower limbs according to each participant's functional capacity. Instructions, supervision, and feedback were provided throughout the sessions. Vital signs, exercise tolerance, symptoms of virtual reality sickness, and other adverse events were monitored.

The primary outcome was the change in exercise-related capillary blood lactate concentration. Lactate was measured using the StatStrip® Lactate Meter from Nova Biomedical, which has a measurement range of 0.3-20.0 mmol/L. Blood samples were collected immediately before and after standardized low-intensity resistance exercise at baseline (Day 1) and following the seven-day intervention period (Day 7). These measurements were used to evaluate acute exercise-related lactate responses and changes in lactate kinetics between Day 1 and Day 7.

Secondary and exploratory outcomes were assessed at baseline and Day 7 and included:

  • Functional independence measured using the Barthel Index.
  • Frailty measured using the 40-item Frailty Index (FI-40).
  • Sarcopenia risk measured using SARC-F.
  • Perceived exercise intensity measured using the Borg Rating of Perceived Exertion Scale.
  • Health-related quality of life measured using the EQ-5D-5L.

The analyses evaluated changes in the measured outcomes over time and compared the intervention and control groups. Statistical analyses were performed using IBM SPSS Statistics version 24.0.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient age 60-90 years old in acute geriatric ward
  • mobilization level 3 and 4
  • able to communicate and follow instructions

Exclusion criteria

  • VR Sickness
  • severe psychosocial problems
  • severe caregiver burden

Treatment and study plan

Virtual Reality Exercise (VRE) using VRAGMENT software

Device

Adjuvant Virtual Reality Exercise (VRE) delivered via Oculus Quest 2 headset with VRAGMENT software, a culturally adapted VR program simulating daily activities (e.g., grocery shopping, phone calls) to induce physical movement. Participants received VRE alongside conventional multimodal exercise (breathing, resistance, aerobic) during hospitalization. Sessions were tailored to individual clinical conditions and aimed to improve fatigue and mobility through gamified rehabilitation

Other names: VRAGMENT

Primary outcomes

  1. Change in Post-Exercise Blood Lactate Concentration (mmol/L)

    Time frame: The change from pre- to post-exercise is measured on Day 1 and again on Day 7. The outcome is the comparison of these changes between the two days

    The absolute change in capillary blood lactate concentration (mmol/L) from pre-exercise to immediately post-exercise. This change will be calculated at two time points: at baseline (Day 1) and one week post-intervention (Day 7). The difference between the Day 7 change and the Day 1 change will be the primary outcome. Measurements will be taken using the StatStrip® Lactate Meter

Secondary outcomes

  1. Change in EQ-5D-5L Health Utility Index

    Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.

    Health-related quality of life is assessed using the EQ-5D-5L descriptive system. The instrument evaluates five dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five response levels, ranging from no problems to extreme problems or inability to perform the activity. Participants' health states are converted into an EQ-5D-5L health utility index using the Indonesian value set. Index values range from -0.865 to 1.000, with higher values indicating better health-related quality of life. The outcome is calculated as the Day 7 index value minus the Day 1 index value. A positive change indicates improvement in health-related quality of life.

  2. Qualitative Pattern of Fatigue via Lactate Kinetics

    Time frame: Patterns are assessed by comparing the kinetic profiles from Day 1 to Day 7

    A qualitative assessment of the overall lactate kinetic response (combining the post-exercise change and clearance rate) to infer clinical patterns of fatigue improvement

  3. Change in Barthel Index Score

    Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.

    Functional independence in activities of daily living is assessed using the 10-item Barthel Index. The instrument evaluates feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, mobility, and stair climbing. The total score ranges from 0 to 20, with higher scores indicating greater functional independence. The outcome is calculated as the Day 7 score minus the Day 1 score. A positive change indicates improvement in functional independence.

  4. Change in 40-Item Frailty Index (FI-40) Score

    Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.

    Frailty is assessed using the 40-item Frailty Index (FI-40), which evaluates the accumulation of health deficits across multiple domains. Each deficit is scored from 0, indicating that the deficit is absent, to 1, indicating that the deficit is fully present. Intermediate values may be assigned when applicable. The FI-40 score is calculated by dividing the total deficit score by the number of deficits assessed. The resulting score ranges from 0 to 1, with higher scores indicating greater frailty. The outcome is calculated as the Day 7 score minus the Day 1 score. A negative change indicates a reduction in frailty.

  5. Change in SARC-F Score

    Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.

    Sarcopenia risk is assessed using the SARC-F questionnaire. The questionnaire evaluates five components: strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each component is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate a greater risk of sarcopenia, and a score of 4 or higher indicates an increased risk of sarcopenia. The outcome is calculated as the Day 7 score minus the Day 1 score. A negative change indicates improvement or a reduction in sarcopenia risk.

  6. Change in Post-Exercise Borg Rating of Perceived Exertion Score

    Time frame: Assessed immediately after standardized low-intensity resistance exercise on Day 1 and Day 7.

    Perceived exercise intensity is assessed immediately after standardized low-intensity resistance exercise using the Borg Rating of Perceived Exertion Scale. The scale ranges from 6, indicating no exertion, to 20, indicating maximal exertion. Higher scores indicate greater perceived exercise intensity. The outcome is calculated as the post-exercise Borg score on Day 7 minus the post-exercise Borg score on Day 1. A negative change indicates lower perceived exertion when performing the standardized exercise.

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients : A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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