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The goal of this study aims to analyze lactate kinetics as an exercise response after conventional multimodal exercise and virtual reality exercise (VRE) in hospitalized geriatric. The main question it aims to answer are:
Participants were randomized into control and VRE group. Peripheral blood lactate was taken immediately before and after low-intensity resistance exercise at baseline and one week after
Sixty geriatric patients were recruited during their hospitalization at RSUPN Dr. Cipto Mangunkusumo (RSCM). Subjects were randomized into control and intervention group. Both groups get conventional multimodal exercise, the intervention group gets additional VRE as adjuvant therapy. Exercise prescription was given after the subjects going through functional assessment conducted by physiatrists. The prescription described the frequency, intensity, interval, and type of exercise that is adjusted to subject's clinical condition. Each subject could have more than one type of exercise, but the most common combination consists of breathing, resistance, and aerobic exercises. VRAGMENT software was administered as VRE to the intervention group. In VRAGMENT, subjects should make phone call, groceries and making payment. Those activities in virtual environment initiated real movement of neck, trunk, arms, and legs. Capillary blood lactate sample was examined using StatStrip® from Nova Biomedical. Measurement range of StatStrip® is 0,3 - 20,0 mmol/L. Lactate examination conducts at baseline and one week after the exercise program. Blood samples were collected immediately pre and post-standardized low-intensity resistance training. The data collected were analyzed using SPSS statistics (version 24.0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Conventional multimodal exercise (standard care) | |
| VRE Intervention Group | Experimental | Conventional exercise + Virtual Reality Exercise (VRAGMENT software on Oculus Quest 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post-Exercise Blood Lactate Concentration (mmol/L) | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate Clearance Rate (% change per minute) | The rate at which blood lactate is cleared following exercise, calculated as the percentage decrease in lactate concentration from the immediate post-exercise peak to a subsequent measurement. This provides a kinetic measure of metabolic recovery | Measured during the recovery phase on Day 1 and Day 7. The outcome is the comparison of the clearance rates between the two days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN Dr. Cipto Mangunkusumo | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34770694 | Background | Cortes-Perez I, Sanchez-Alcala M, Nieto-Escamez FA, Castellote-Caballero Y, Obrero-Gaitan E, Osuna-Perez MC. Virtual Reality-Based Therapy Improves Fatigue, Impact, and Quality of Life in Patients with Multiple Sclerosis. A Systematic Review with a Meta-Analysis. Sensors (Basel). 2021 Nov 6;21(21):7389. doi: 10.3390/s21217389. | |
| 39264074 |
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IPD will not be shared to protect participant confidentiality
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| 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 | Jun 30, 2025 | Aug 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2024 | Aug 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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This study utilized a two-arm, parallel-group, randomized controlled trial (RCT) design with single-blinding to evaluate the efficacy of Virtual Reality Exercise (VRE) as an adjuvant therapy for hospitalized geriatric patients. Sixty participants were randomly assigned to either a control group receiving conventional multimodal exercise or an intervention group receiving conventional exercise plus VRE using VRAGMENT software on Oculus Quest 2. Both groups underwent simultaneous interventions with outcomes measured at baseline and one week post-intervention, focusing on lactate kinetics as the primary outcome. The single-blind design ensured participants were unaware of their group allocation to minimize bias, while clinicians administering the interventions remained unblinded due to the nature of the VR therapy.
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Participants were blinded to group allocation (control vs. VRE intervention) to minimize performance bias
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| Qualitative Pattern of Fatigue via Lactate Kinetics | A qualitative assessment of the overall lactate kinetic response (combining the post-exercise change and clearance rate) to infer clinical patterns of fatigue improvement | Patterns are assessed by comparing the kinetic profiles from Day 1 to Day 7 |
| Vavricka J, Broz P, Follprecht D, Novak J, Krouzecky A. Modern Perspective of Lactate Metabolism. Physiol Res. 2024 Aug 31;73(4):499-514. doi: 10.33549/physiolres.935331. |
| 19885119 | Background | Goodwin ML, Harris JE, Hernandez A, Gladden LB. Blood lactate measurements and analysis during exercise: a guide for clinicians. J Diabetes Sci Technol. 2007 Jul;1(4):558-69. doi: 10.1177/193229680700100414. |
| 25364137 | Background | Cho H, Sohng KY. The effect of a virtual reality exercise program on physical fitness, body composition, and fatigue in hemodialysis patients. J Phys Ther Sci. 2014 Oct;26(10):1661-5. doi: 10.1589/jpts.26.1661. Epub 2014 Oct 28. |
| 17562631 | Background | Schneider SM, Hood LE. Virtual reality: a distraction intervention for chemotherapy. Oncol Nurs Forum. 2007 Jan;34(1):39-46. doi: 10.1188/07.ONF.39-46. |
| 28474000 | Background | Patino-Hernandez D, David-Pardo DG, Borda MG, Perez-Zepeda MU, Cano-Gutierrez C. Association of Fatigue With Sarcopenia and its Elements: A Secondary Analysis of SABE-Bogota. Gerontol Geriatr Med. 2017 Apr 10;3:2333721417703734. doi: 10.1177/2333721417703734. eCollection 2017 Jan-Dec. |
| 33415290 | Background | Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec. |