Feasibility of Virtual Reality-assisted Ergometer Cycling in Addition to Regular Rehabilitation During Municipality-based Inpatient Rehabilitation Care

NCT07459439 | Not Yet Recruiting

• 1 other identifier: VR-C-REHAB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

VR-C-REHAB is a single-group pilot and feasibility study examining the practicality of implementing virtual-reality-assisted ergometer cycling as an adjunct to usual municipal inpatient rehabilitation for older adults (≥65 years). Many individuals admitted to temporary inpatient care present with low physical activity levels and fluctuating motivation, reducing the achievable exercise dose. Virtual reality may enhance engagement, enjoyment, and adherence, but its feasibility in this setting must be evaluated before conducting a future effect trial. The primary objective is to determine whether participants can achieve an adequate exercise dose, defined as the proportion of completed VR-cycling sessions out of those offered (target: ≥75%). Secondary feasibility outcomes include recruitment rate, safety and acceptability, and total cycling time. Exploratory outcomes include change in the 10-Meter Walk Test and session-level motivation (0-10). The intervention consists of 20 minutes of VR-assisted cycling, three times weekly for up to four weeks, delivered alongside standard rehabilitation. Data are collected at baseline, during each session, and at completion. Analyses are descriptive, focusing on the precision of feasibility estimates. Progression criteria (Go/Amend/Stop) are based on adherence, recruitment, and safety. The results will inform the design and implementation of a subsequent controlled study.

Conditions

Older Adults (65 Years and Older); Outpatient Treatment; Rehabilitation Frail Elderly Subjects

Keywords

municipality-based inpatient rehabilitation care

Outcome Measures

Primary Outcomes (1)

• Exercise Adherence: In percent

  Definition: NumbercompletedVR-bicyclessessions/ NumberofferedVR-bicyclesessioner pr. participant, summarised and/or averaged for the entire cohort. The feasibility goal is set at ≥75%. "Offered sessions" are defined as the planned three weekly sessions during the period the participant is admitted and available, excluding days with clearly documented contraindications or acute illness according to predetermined criteria. The reasons for lack of training will be explicitly described in the manual as "illness," covering biological illness or other admitted causes, and "demotivation," which encompasses reasons such as tiredness, demotivation, or discomfort. The actual cause will be described.

  4 weeks (at every exercise session)

Secondary Outcomes (4)

• 1. Recruitment Rate: Percent

  Baseline testing (day 0)

• walk speed

  baseline testing and follow up testing after ending the intervention( up to 4 weeks later)

• Motivation

  during every session from enrollment until end of intervention (max 4 weeks)

• Total Time Spent Cycling in minutes

  Week 4 (or after conclusion of the intervention if that happens before)

Other Outcomes (1)

• Safety/Acceptability (Recommended in Feasibility):

  4 weeks (at every exercise session if it occurs)

Study Arms (1)

Intervention

EXPERIMENTAL

Other: VR cycling

Interventions

VR cycling OTHER

* Intervention: 20 minutes of cycling with VR goggles in addition to regular treatment. * Frequency: Three times weekly. * Duration: Up to 4 weeks (dependent on discharge timing). * Delivery: Supervised by physiotherapists or therapeutic staff according to local practices.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years
• Referred to rehabilitation during a stay at temporary inpatient care
• Assessed by a therapist as capable of participating in seated cycling (possibly supervised)
• Able to provide informed consent (with relevant support according to local guidelines, if necessary).

You may not qualify if:

• Medical contraindications to moderate physical activity/cycling (e.g., unstable angina, uncontrolled arrhythmia, acute infection with significant impact)
• Severe dizziness/vestibular symptoms likely to be exacerbated by VR use
• Known photosensitive epilepsy or other conditions posing significant risk with VR stimulation
• Unresolved vision/perception issues or severe nausea rendering VR use unsuitable
• Participation in another intervention study that interferes with this intervention.

Sponsors & Collaborators

• Horsholm Municipality: lead

Study Sites (2)

Bispebjerg Hospital

Copenhagen, Denmark

Location

Sundheds- og rehabiliteringscenter Hørsholm

Hørsholm, 2970, Denmark

Location

Related Publications (4)

• Mocco A, Valmaggia L, Bernardi L, Alfieri M, Tarricone I. Enhancing Physical Activity with Immersive Virtual Reality: A Systematic Review. Cyberpsychol Behav Soc Netw. 2024 May;27(5):303-317. doi: 10.1089/cyber.2023.0394. Epub 2024 Mar 20.

  PMID: 38506442 BACKGROUND

• Hajder Đ,Bjelica B,Bubanj S,Aksović N,Marković M,Arsenijević R,Lupu GS,Gašić T,Sufaru C,Toskić L,Dobreci DL,Dobrescu T,Sava MA

  BACKGROUND

• Rytterström P,Strömberg A,Jaarsma T,Klompstra L

  BACKGROUND

• Campo-Prieto P,Cancela-Carral JM,Rodríguez-Fuentes G

  BACKGROUND

Central Study Contacts

Niklas Grundt Hansen, PhD Candidate

CONTACT

+45 61277932; grundt.niklas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and developement therapist, Msc. PT, PhD Candidate

Model Details: interventional study with allocation: N/A, masking: none/open label

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 9, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be alailable from june 2026 onwards
• Access Criteria: By contacting PI data will be provided on request.

Locations

DK (2)