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

NCT07149272 | Completed

• 1 other identifier: KET-261/UN2.F1/ETIK/PPM.00.02/
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Fatigue; Lactate; Frailty; Sarcopenia in Elderly; Quality of Life

Keywords

Exercise; Geriatric; Lactate; Virtual Reality; frailty; quality of life; sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in EQ-5D-5L Health Utility Index

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

• Qualitative Pattern of Fatigue via Lactate Kinetics

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

• Change in Barthel Index Score

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

• Change in 40-Item Frailty Index (FI-40) Score

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

• Change in SARC-F Score

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

Study Arms (2)

Control Group

NO INTERVENTION

Conventional multimodal exercise (standard care)

VRE Intervention Group

EXPERIMENTAL

Conventional exercise + Virtual Reality Exercise (VRAGMENT software on Oculus Quest 2)

Device: Virtual Reality Exercise (VRE) using VRAGMENT software

Interventions

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

Also known as: VRAGMENT

VRE Intervention Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• VR Sickness
• severe psychosocial problems
• severe caregiver burden

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (7)

• 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.

  PMID: 34770694 BACKGROUND

• 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.

  PMID: 39264074 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.

  PMID: 19885119 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.

  PMID: 25364137 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.

  PMID: 17562631 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.

  PMID: 28474000 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.

  PMID: 33415290 BACKGROUND

MeSH Terms

Conditions

Fatigue; Frailty; Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group allocation (control vs. VRE intervention) to minimize performance bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Melinda Harini, Sp.K.F.R., Ger. (K)

Model Details: 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. All 153 eligible participants were randomized to either the intervention or control group. Participants could discontinue the intervention. The intervention group received conventional multimodal exercise supplemented with VRE using the VRAGMENT software delivered through an Oculus Quest 2 headset. Both groups underwent simultaneous interventions with outcomes measured at baseline and one week post-intervention, focusing on lactate kinetics, functional independence, frailty, sarcopenia risk, perceived exercise intensity, and quality of life.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 VRE therapy.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 29, 2025
• Study Start: February 16, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)