Lactate Kinetics Analysis Related to Low-Intensity Resistance Exercise

NCT07149272 | Completed

• 1 other identifier: KET-261/UN2.F1/ETIK/PPM.00.02/
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.are there any difference in post exercise lactate at day 1 and 7 between the two groups?
2. 2.does the lactate concentration reduces after low intensity resistance exercise in subject with high resting lactate?

Conditions

Fatigue; Lactate

Keywords

Exercise; Geriatric; Lactate; Virtual Reality

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 (2)

• Lactate Clearance Rate (% change per minute)

  Measured during the recovery phase on Day 1 and Day 7. The outcome is the comparison of the clearance rates between the two days

• Qualitative Pattern of Fatigue via Lactate Kinetics

  Patterns are assessed by comparing the kinetic profiles from Day 1 to 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; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

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. 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.

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 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)