Feasibility of Virtual Reality-assisted Ergometer Cycling in Addition to Regular Rehabilitation During Municipality-based Inpatient Rehabilitation Care: A Single-group Pilot- and Feasibility-trial - VR-C-Rehab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Exercise Adherence: In percent
研究概览
简要总结
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 15 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.
详细描述
Background and Rationale:
Elderly individuals with diminished physical capacity who are admitted to temporary inpatient rehabilitation often exhibit low levels of physical activity and motivation, which can adversely affect the exercise dose during their stay. Cycling is recognized as a safe and effective form of exercise; however, its implementation is often hindered by low commitment and fluctuating daily energy levels.
Virtual reality (VR) has the potential to enhance motivation, perceived enjoyment, and adherence to training by providing distraction, engagement, and a more stimulating exercise environment. Prior to conducting a potential impact study, it is essential to assess the feasibility of recruitment, implementation, acceptance, and exercise dose within municipal inpatient rehabilitation settings.
Objective and Research Question:
Overall Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Intervention
干预措施: VR cycling (Other)
结局指标
主要结局
Exercise Adherence: In percent
时间窗: 4 weeks (at every exercise session)
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.
次要结局
- 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))
研究者
Niklas Grundt Hansen
Research and developement therapist, Msc. PT, PhD Candidate
Horsholm Municipality