MedDataX Logo

Lactate Kinetics Analysis Related to Low-Intensity Resistance Exercise

NCT ID: NCT07149272

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. 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?

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatigue Lactate

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exercise Geriatric Lactate Virtual Reality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants were blinded to group allocation (control vs. VRE intervention) to minimize performance bias

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Conventional multimodal exercise (standard care)

Group Type NO_INTERVENTION

No interventions assigned to this group

VRE Intervention Group

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

Group Type EXPERIMENTAL

Virtual Reality Exercise (VRE) using VRAGMENT software

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Exercise (VRE) using VRAGMENT software

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VRAGMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melinda Harini

Dr. dr. Melinda Harini, Sp.K.F.R., Ger. (K)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34770694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39264074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19885119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25364137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17562631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28474000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33415290 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KET-261/UN2.F1/ETIK/PPM.00.02/

Identifier Type: -

Identifier Source: org_study_id