FatigueNCT07149272
Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients
A study testing Virtual Reality Exercise (VRE) using VRAGMENT software in people with Fatigue and Lactate, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- What is being tested?
- Virtual Reality Exercise (VRE) using VRAGMENT software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Feb 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 60-90 years old in acute geriatric ward
- mobilization level 3 and 4
- able to communicate and follow instructions
Who cannot join
- VR Sickness
- severe psychosocial problems
- severe caregiver burden
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients : A Randomized Control Trial
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:
Read more
- are there any difference in post exercise lactate at day 1 and 7 between the two groups?
- does the lactate concentration reduces after low intensity resistance exercise in subject with high resting lactate?
- 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.
Read the detailed description
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.
VRAGMENT itself is a daily shopping simulation game.To align safely with mobilization levels 3 and 4, the virtual mechanics replaced physical walking with manual controller manipulation and virtual locomotion.
VRAGMENT Training Procedure:
- Before each training session, the researchers reviewed the indications and contraindications for mobilization. Training was conducted only when the participant had no contraindications to mobilization.
- Participants received a detailed explanation of the activities to be performed during the VRAGMENT training and the final objective of the game.
- Participants underwent familiarization with the Oculus Quest 2 headset, which served as the hardware platform for VRAGMENT. The virtual play area was also calibrated according to each participant's position, range of motion, and clinical condition.
- Vital signs were assessed immediately before and after each training session to monitor the participant's physiological response and safety.
- Participants initiated the game and completed the VRAGMENT activities sequentially. Throughout the session, the healthcare staff and attending physician were permitted to provide instructions, feedback, and verbal encouragement without directly performing the activities for the participant.
- The level of difficulty was progressively increased when the participant was able to complete the entire sequence of activities within a given level in at least 50% less time than their initial completion time for that level.
- The duration of each training session was recorded. Participants were expected to complete 30 minutes of training per day, either continuously or in divided sessions according to their tolerance and clinical condition. Training was conducted five times.
Evaluation was performed within seven days after the first session.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.
- Conditions
- Fatigue, Lactate, Frailty, Sarcopenia in Elderly, Quality of Life
- Being tested
- Virtual Reality Exercise (VRE) using VRAGMENT software
- Keywords
- Exercise, Geriatric, Lactate, Virtual Reality, frailty, quality of life, sarcopenia
- Medical subject headings
- Fatigue, Frailty, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exercise (VRE) using VRAGMENT softwareDevice
Also called VRAGMENT
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Conventional multimodal exercise (standard care) |
| VRE Intervention Group | Experimental | Conventional exercise + Virtual Reality Exercise (VRAGMENT software on Oculus Quest 2) Receives: Device: Virtual Reality Exercise (VRE) using VRAGMENT software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Assessed at baseline on Day 1 and after the intervention period on Day 7.
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
Measured: Patterns are assessed by comparing the kinetic profiles from Day 1 to Day 7
Change in Barthel Index Score
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.
Measured: Assessed at baseline on Day 1 and after the intervention period on Day 7.
Change in 40-Item Frailty Index (FI-40) Score
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.
Measured: Assessed at baseline on Day 1 and after the intervention period on Day 7.
Change in SARC-F Score
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.
Measured: Assessed at baseline on Day 1 and after the intervention period on Day 7.
Change in Post-Exercise Borg Rating of Perceived Exertion Score
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.
Measured: Assessed immediately after standardized low-intensity resistance exercise on Day 1 and Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start16 Feb 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Harini, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149272
- Sponsor's protocol ID
- KET-261/UN2.F1/ETIK/PPM.00.02/
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant confidentiality
Publications
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.
PubMed 34770694Vavricka 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.
PubMed 39264074Goodwin 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.
PubMed 19885119Cho 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.
PubMed 25364137Schneider 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.
PubMed 17562631Patino-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.
PubMed 28474000Ioannou 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.
PubMed 33415290
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients : A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07149272
- Acronym / sponsor ID
- KET-261/UN2.F1/ETIK/PPM.00.02/
- Conditions
- Fatigue, Lactate, Frailty, Sarcopenia in Elderly, Quality of Life
- Keywords
- Exercise, Geriatric, Lactate, Virtual Reality, frailty, quality of life, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- are there any difference in post exercise lactate at day 1 and 7 between the two groups?
- does the lactate concentration reduces after low intensity resistance exercise in subject with high resting lactate?
- 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.
Detailed description
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.
VRAGMENT itself is a daily shopping simulation game.To align safely with mobilization levels 3 and 4, the virtual mechanics replaced physical walking with manual controller manipulation and virtual locomotion.
VRAGMENT Training Procedure:
- Before each training session, the researchers reviewed the indications and contraindications for mobilization. Training was conducted only when the participant had no contraindications to mobilization.
- Participants received a detailed explanation of the activities to be performed during the VRAGMENT training and the final objective of the game.
- Participants underwent familiarization with the Oculus Quest 2 headset, which served as the hardware platform for VRAGMENT. The virtual play area was also calibrated according to each participant's position, range of motion, and clinical condition.
- Vital signs were assessed immediately before and after each training session to monitor the participant's physiological response and safety.
- Participants initiated the game and completed the VRAGMENT activities sequentially. Throughout the session, the healthcare staff and attending physician were permitted to provide instructions, feedback, and verbal encouragement without directly performing the activities for the participant.
- The level of difficulty was progressively increased when the participant was able to complete the entire sequence of activities within a given level in at least 50% less time than their initial completion time for that level.
- The duration of each training session was recorded. Participants were expected to complete 30 minutes of training per day, either continuously or in divided sessions according to their tolerance and clinical condition. Training was conducted five times.
Evaluation was performed within seven days after the first session.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Conventional multimodal exercise (standard care) |
| VRE Intervention Group | Experimental | Device: Virtual Reality Exercise (VRE) using VRAGMENT softwareConventional exercise + Virtual Reality Exercise (VRAGMENT software on Oculus Quest 2) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age 60-90 years old in acute geriatric ward
- mobilization level 3 and 4
- able to communicate and follow instructions
Key exclusion criteria (3 listed)
- VR Sickness
- severe psychosocial problems
- severe caregiver burden
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Exercise (VRE) using VRAGMENT softwareAlso: VRAGMENTAdjuvant 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 | Device | VRE Intervention Group |
Primary outcome
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
6 secondary outcomes
Change in EQ-5D-5L Health Utility Index
Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.
Qualitative Pattern of Fatigue via Lactate Kinetics
Time frame: Patterns are assessed by comparing the kinetic profiles from Day 1 to Day 7
Change in Barthel Index Score
Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.
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.
Change in SARC-F Score
Time frame: Assessed at baseline on Day 1 and after the intervention period on Day 7.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 34770694Cortes-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.
- Background: PubMed 39264074Vavricka 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.
- Background: PubMed 19885119Goodwin 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.
- Background: PubMed 25364137Cho 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.
- Background: PubMed 17562631Schneider 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.
- Background: PubMed 28474000Patino-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.
- Background: PubMed 33415290Ioannou 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.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exercise (VRE) using VRAGMENT software in people with Fatigue and Lactate, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149272, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.